The UK's #1 Pharma packaging child resistant design experts, Origin. We engage in the design, manufacture and consolidated supply of pharmaceutical packaging, partnering with licence holders and CMOs. Our focus has been continually refined to support the creation of entirely effective packaging solutions underpinned by a robust supply chain and outstanding client services activity.
When a new drug hits the development stage it can go through a lengthy and complex process before it is seen by the public or distributed to pharmacies. In reality, only two tested innovations out of 10,000 actually become fully licensed treatments. All in all, it can take an average of ten to fifteen years for a new drug to make it from a petri dish in a laboratory onto the shelves of the pharmacy.
The First Stage of Discovering a New Drug
When a new drug is discovered, it relies heavily on in depth knowledge of a specific disease. It is important to understand how biological processes work in the body, as well as the side effects of certain illnesses. This sort of knowledge will reveal potential areas that the drug can target during treatment. At the moment, scientists are now able to design innovative medicines due to immersing information on the shape of biological molecules. This just goes to show how important detailed studies are during the process of discovering a new drug.
Why is the First Stage So Crucial?
These initial steps should be taken very seriously, as studies will reveal more and more about the drug in question. Usually, animals and cells will be used to test the drug first of all. However, this does not mean that the results will be the same in thousands of humans. Often drugs that show positive results in animals won’t have the same effect on humans, so this is why it is important to be cautious with the testing process. This can provide critical data for future trials, but a successful animal trial does not always pave the way for a groundbreaking new treatment.
Qualifying For the First Stage
At this pound thousands of new drugs will have been tested and created so that those with potential can be identified. The dropout rate at this point is very high with less than one in one thousand continuing to the next level. If a new compound shows potential it will then be put through several laboratory tests because a clinical trial on humans can be authorized.
The Three Phases of a Clinical Trial
First of all, the new drug needs to be tested in order to determine its level of safety. At this point it is usually given to a small selection of healthy people. This important phases assists researchers in grasping how the medicine works and what kind of dosage will be suitable.
Studies can now begin, as long as the drug is proven to be safe. The medicine can now be used on people with the condition to see how effective it will be. These in depth trials can take several years to complete, with an average of one or two hundred participants. The study can take several forms, such as controlled, randomised or double blind. In a controlled study the drug is compared to a placebo. In a randomised situation, volunteers are randomly allocated the drug or the placebo. Whereas, in a double blind study neither the participant nor the medical team know which treatment they are going to get.
A larger study can then commence if the medicine shows positive results. The clinical trial will usually expand out to other countries and last another few years. This gives the researchers time to assess the potential of the new compound amongst a broader range of people.
The Process of Licensing
When it comes to drug development, licensing is a crucial stage to get past. In the UK, the MHRA (Medicines and Healthcare products Regulatory Agency) or the EMA (European Medicines Agency) will be the regulating authorities. In the USA the FDA (Food and Drug Administration) are those responsible for protecting public health.
During this process a DMF or Drug Master File might be prepared by the pharma manufacturer and submitted to the appropriate regulator for that area. This document will provide the regulator with information about what was used during the manufacturing process.
Licensing approval can take an average of 12 years and it costs approximately one billion dollars to develop one new successful medine.
Using a New Medicine
Once a drug has been licensed it will be closely surveyed for safety. Within the pharmaceutical packaging there will always be a PIL (Patient Information Leaflet), which outlines how the medicine should be taken and what the potential side effects are.
Clinical trials can also continue well after a compound has been given its licence. This is done so that new treatment uses can be found, the effectiveness can be measured in a broader range of patients and it can be compared to other current treatments.
Although a licence is usually granted for one specific purpose, doctors will be free to prescribe this for other purposes as they see fit. New treatment areas might come into light as a result, but a pharma company will need to show the new data to the authorities in order to extend their licence.
The Process of Patenting
Pharma companies will patent any type of compound that shows potential results during the early stages of testing and development. This stops other companies from copying it for up to twenty years and it also covers the intellectual properties of the drug. Companies will patent their products so that it can recoup the costs of development and so they can invest in future innovative drugs.
Millions of Dollars of Research Can Be Lost Instantly
At any point in the development process a new drug could be rejected at the drop of a hat. Millions of dollars can be lost as a result of these snap decisions, however they are usually due to safety issues, quality or overall effectiveness. A drug won’t be pulled from testing for no reason, however it can still be devastating to see after all the research, development and testing has been carried out. There have been many drugs that have failed at the last hurdle including lonafarnib (a cancer drug) and isradipine for Parkinson’s Disease.
This wealth of information just goes to show the time it takes to develop a new drug, as well as the astounding costs. Many patients have benefitting from new and innovative clinical trials. Even though it is a lengthy process, pharma companies will always continue to develop their research for the greater good.
Sunday, April 7th is World Health Day, an annual campaign built to increase global awareness of universal health coverage with a particular focus on what services should be available. The event Is organized by the World Health Organization, and signals a major date in their calendar. But exactly who is WHO, and what are their aims for the World Health Day 2019?
Here’s all you need to know about the global agency of international public health and this year’s event, which also marks the 70th anniversary of the organization’s formation in 1948.
Who is WHO?
Formed on April 7th, 1948, having signed its initial constitution between 61 countries in 1946, WHO is an agency that is linked to the United Nations and has its HQ in Geneva, Switzerland. Its remit is to promote the human right of good health to everyone across the globe.
WHO is currently headed by Director General Tedros Adhanom, and is responsible for conducting the annual World Health Survey and World Health Report, as well as celebrating World Health Day itself. Their findings and advice are instrumental to continued developments.
The organization has played a key role in eradicating smallpox and the continued fight against TB, HIV, and various other diseases. They also concern themselves with matters relating to nutrition and occupational health across the globe.
What Are WHO’s Main Principles?
The World Health Organization believes that health is a human right and strives to turn universal coverage into a reality. With over half of the global population unable to access the health services they require, and additional 100,000 being forced into poverty through paid health support, WHO fights to improve education and facilities to allow people to gain adequate health services for their families.
World Health Day is an annual celebration to further underline those intentions. WHO places a significant emphasis on primary health care, which is defined as the first level of contact with the health system where patients receive their health care. Primary care screening for health problems, vaccines, family planning, rehab, and treatments for various conditions. With a focus on cost-efficiency and stability, this is one of the primary functions of the system,
Moreover, WHO is dedicated to building a global network of health care providers that understand the traditions, cultures and practices of their communities, with a particular focus on preparation for outbreaks and emergencies. Through skilled health workers, people-centric care, and continued investment into primary health care, the goal is to – one day – achieve universal coverage.
World Health Day 2019: What You Need To Know
World Health Day is the annual celebration of the work that WHO completes, and is built to further increase the public awareness of world health issues. This ultimately focuses around the idea of helping people gain a deeper appreciation of the need for global health coverage, including what services should be available, along with information on past progress and the journey ahead.
WHO strives to celebrate the great work conducted by health care worker across the planet, and encourages their participation throughout the campaign. Their input is used to help the decision-makers incorporate ideas regarding the primary health care requirements of people in different parts of the world. Moreover, health care givers are provided with visual material and paraphernalia to gain further exposure and help the people at all levels gain a deeper understanding of the campaign as a whole.
The campaign also aims to give health care decision-makers, governors, and ministers a chance to plug gaps in relation to the health care in their individual countries and territories. It is also an opportunity to celebrate the progress that has been made in recent times on the back of the ongoing campaign.
World Health Day also coincides with the release of the annual World Health Report, which includes key data on pressing issues such as newborn and child health, noncommunicable diseases, mental health and environmental risks. The information relates to individual regions as well as the planet as a whole.
The Theme for 2019
Since 1995, World Health Day has carried a specific theme. They have been as follows:
1995: Global Polio Eradication
1996: Healthy Cities for better life
1997: Emerging infectious diseases
1998: Safe motherhood
1999: Active aging makes the difference
2000: Safe Blood starts with me
2001: Mental Health: stop exclusion, dare to care
2002: Move for health
2003: Shape the future of life: healthy environments for children
2004: Road safety
2005: Make every mother and child count
2006: Working together for health
2007: International health security
2008: Protecting health from the adverse effects of climate change
2009: Save lives, Make hospitals safe in emergencies
2010: Urbanization and health: make cities healthier
2011: Antimicrobial resistance: no action today, no cure tomorrow
2012: Good health adds life to years
2013: Healthy heart beat, Healthy blood pressure
2014: Vector-borne diseases: small bite, big threat
2015: Food safety
2016: Halt the rise: beat diabetes
2017: Depression: Let’s talk
2018: Universal Health Coverage
In 2019, the theme of Universal Health Coverage (UHC) continues due to (as mentioned above) the World Health Organization’s decision to make this a priority. People deserve health support irrespective of geographic location or financial status, World Health Day 2019 looks to push towards this goal once more.
What Can You Do To Support The Cause
At a global public level, World Health Day is primarily concerned with increasing universal awareness and education. Therefore, the best thing you can do this April 7th is play an active role. Whether it’s paying greater attention to the visual materials produced by WHO, wearing badges and paraphernalia, or sharing social media posts doesn’t matter. Anything you do to further support the cause is a step in the right direction.
Let’s hope that one day, the celebrations will be solely about the success of eradicating those global health issues rather than also promoting further development. That’s the dream.
Origin Pharma Contributed an article to EPM Magazine – full story below
Like every industry, the pharma sector is poised on the edge of its seat in anticipation of a final agreement on Brexit.
The UK will officially leave the European Union on March 29th (if all goes to plan) and the terms of the exit will dictate how British pharma firms can trade with and market their products to Member States and the rest of the world.
Marketing authorisation for products in the EU is currently governed by the European Medicines Agency (EMA), based in London. The immediate consequence of Brexit is that the EMA will relocate to the Netherlands, with the likelihood of losing key members of staff and adding complexities when it comes to remits and responsibilities.
The EMA is currently working on the eventuality of a no-deal Brexit, which would leave the UK classed a ‘third country’, meaning they’ll no longer be able to engage as a ‘co-rapporteur’ in the marketing authorisation process of products in the EU.
The UK currently contributes heavily to the regulation of EU medicine approval – used as a reference Member State in 45% of decentralised EU medicine approvals – so, Brexit will see the supply chain impacted. Plus, the UK exports a significant amount of products to the EU, and a no-deal eventuality would impact the £11.9 billion of medicinal exports and put the EU market under strain.
A no-deal agreement would also see the responsibility for human medication marketing in the UK fall on the Medicines and Healthcare Products Regulatory Agency (MRHA). It would require new laws and systems for packaging, labelling and patient information leaflets to ensure high standards and safety, putting stress on regulatory bodies to ensure they’re prepared.
The problem is, the MRHA approval process is largely industry-funded and would struggle to sustain itself on only the fees paid for the review of medicine in the UK. It could see the number of authorisations granted drop, unless funding could be secured from the health budget or public funding.
It will, however, provide a platform for the MHRA to establish itself as a global leader in medicine regulation, including marketing authorisation and packaging. The MHRA already contributes heavily to the EU workload and will look to grow its authority as it undertakes greater responsibility in the case of a no deal Brexit, where the UK looks to begin trading in new markets.
Alone, the UK is a much less appealing market though, representing just 3% of the global pharmaceutical market compared with the EU’s 22%. As the UK looks to expand its trading opportunities it may struggle, with attractive countries like USA, China and Russia signing mutual recognition agreements with the EU.
The UK government is preparing for future customs arrangements with the EU, hoping to minimise disruption post-Brexit. However, Brexit will inevitably add costs which could cause businesses to move elsewhere and result in damaging border delays. This will cause serious problems for time-sensitive medicines which require delivery in as little as 24 hours in many cases, potentially leaving patients without vital medication.
Pharmaceutical packaging is an industry going from strength to strength and its shows no signs of slowing down. In fact, by 2025 the market is expected to be worth $128 billion.
The main drivers of this growth are: increased global demand for medication from emerging economies; an ageing population; an increase in chronic diseases; antimicrobial resistance and stricter environmental and medical regulation.
Rich Quelch, Global Head of Marketing at Origin, previews the pharma packaging innovations and challenges we can expect to see in 2019.
A key priority for the pharma packaging industry will be to continue to support the wider health sector in promoting medication adherence.
With around 200,000 people in the EU alone dying each year from not properly adhering to medical advice, global health services are beginning to feel the economic strain.
Smart packaging – like technology to track and accurately monitor dosage information and give patients timely reminders – is the future of pharma, increasing patient compliance and providing valuable digitised feedback to healthcare professionals.
It can also help solve problems of unauthorised access to medicines, including promoting child-resistance. Tamper-evident packaging and pre-filled syringes are examples of innovations expected to become more mainstream.
Pharma packaging brands could reap the rewards of pioneering child-friendly packaging. With some companies achieving child-resistance levels of F4 to F1, attitudes are changing. F8 will become less unacceptable and those leading the way in terms of safety will see rising demand.
The fallout from Brexit
The UK is set to officially leave the EU – with or without a deal – on March 29th, causing disruption across the global pharma industry.
Whatever the final terms of Brexit, UK pharma firms won’t be able to act as ‘co-rapporteurs’ in the marketing authorisation process of EU products anymore.
Also, products marketed in the UK which are currently approved by the European Medicines Agency (EMA), will become the responsibility of the Medicines and Healthcare Products Regulatory Authority (MRHA) in the case of a no-deal agreement.
Consequently, new laws and systems for packaging, labelling and patient information leaflets will need to be made in order to meet the requirements and safety standards currently set by the EMA. Any divergence could lead to the demand for the duplication of facilities and roles to enable access to products, costing companies millions to establish and maintain.
Britain’s exit from the EU will likely affect the global pharma packaging supply chain too, as the UK is a significant exporter of medicinal products. Import and export tariffs would lead to a “double charge”, costing more for stakeholders and possibly seeing them take their business elsewhere.
Another concern is the possible border delays that could occur in the possibility of a no-deal Brexit. Many medicines are time and temperature sensitive, and hold-ups at borders could see large stock become unsellable. Consistent delays would mean new ways of transporting and storing goods would have to be considered, with packaging innovation playing a key role.
Counterfeit pharmaceuticals is the world’s largest fraud market, worth over $200 billion per year and it’s not just the matter of lost earnings for legitimate manufacturers that’s the issue.
Those consuming fake products have no guarantee what they’re taking is what it claims to be, which in some cases can contribute to the spread (rather than cure) of illnesses and antimicrobial resistance.
In a bid to tackle counterfeiting, a new EU law will come into play this February, making digital mass serialisation a compulsory part of pharma manufacturing. This involves random, pseudo codes being generated for each product and verified on the databases of supplier companies before going to market.
Digital watermarks will also become more widely used, offering an extra layer of protection by providing invisible, encoded data on packaging that can only be verified by specialised software. It can be captured using webcam, mobile phones and other scanning equipment, but is invisible to the human eye.
Keeping pace with biologics
Biologics are undoubtedly the future of medicine. These complex medicines aren’t like traditional drugs as they aren’t chemically synthesised and so can’t be mass-produced. As such, biologic medicines can only be produced in small batches.
They’re also temperature sensitive and vulnerable to contamination, making packaging design more difficult as it must stop any contamination or degradation. Traditional materials like glass, plastics and rubber aren’t suitable materials, due to the ability of metals to be extracted, which could degrade the biologic protein structure.
For this reason, we’ll see a greater use of fluoropolymers and cyclic olefin plastics, which don’t use any degradable stabilising agents and therefore provide a protective barrier between the product and environment.
However, as biologics differ so much in structure, we won’t see mass production of generic biological packaging, instead tailored products will be the priority. For example, materials like silicon oil – typically used to lubricate plungers in pre-filled syringes – can cause protein aggregation, so for biologics we can expect individual testing to occur for each medicine.
An eco-friendly future
The use and wastage of plastic across the pharma supply chain will continue to be a major focus in 2019, following a warning by the UN our oceans will contain more plastic than fish by 2050 unless all industries take action.
The future of pharma packaging will see a shift towards more sustainable materials, moving away from plastic which the industry has been so heavily reliant on for design and manufacturing.
Attempts to limit plastic waste will see the continued application of polyethene terephthalate (PET), which can be broken down to molecular level and converted back into PET. Now the technology has proven successful in early testing, we’ll start to see it move into global production.
New techniques are also making it widely possible to reduce waste. For example, 3D visualisation techniques eliminate the need for multiple prototype designs and computer-aided manufacturing like 3D printing uses only exact materials, minimising waste.
Antimicrobial resistance (AMR) is a complex and global issue, affecting all regions of the world. If current trends continue, it’s believed by 2050 antibiotic resistance will cause more deaths per year than cancer, becoming the world’s biggest killer.
As such, AMR is currently high on the political agenda of nation’s around the world as a sustainable solution is sought to reduce the rate at which antimicrobial pathogens are developing immunity to modern medicine.
However, the role of pharma packaging innovation is rarely discussed. While packaging alone does not hold the answer, it has an important part to play in making sure the healthcare system is part of the solution and not the problem.
Understanding the problem
To have a meaningful debate on the AMR crisis, it’s firstly important to understand the key factors currently contributing to its development.
The following contributors are widely cited as accelerating the rate at which bacteria is becoming immune and the emergence of more resistant strains: pharmaceutical waste; the over-prescribing and lack of access to antibiotic drugs; falsification of medicines; poor hygiene practices and the increase in global trade and travel.
The consequences of AMR are far-reaching, reducing our ability to treat common infectious diseases resulting in prolonged illness, more complications and higher fatality rates; the accelerated spread of infections due to ineffective treatments; compromising advances in medicines because of the risk of infection; and placing increasing financial pressure on global health care systems.
Since the historic United Nations Declaration on AMR was agreed in 2016, efforts have intensified across scientific, political and economic spheres to tackle it. However, evidence suggests while positive steps have been taken to slow the pace of AMR, there’s still a long way to go.
The World Health Organization (WHO) released a progress report in the summer which summarised: “progress with developing and implementing plans is greater in high-income than low-income countries but all countries have scope for improvement. No country is reporting established sustained capacity at scale in all domains”.
If this was a school report it would be “showing promise but must do better”.
Strengthening the frontline
Overuse and incorrect use of antibiotics is a major driver of resistance. A recent UK study estimated a fifth of prescriptions are inappropriately prescribed by GPs for illnesses such as a sore throat, cough, sinusitis and ear infections.
There’s a growing body of evidence suggesting the mismatch between dose amounts and course-length mandated by drug manufacturers and prescribers is leading to a considerable quantity of wasted and redundant antibiotics.
For example, a study published in the Australian and New Zealand Journal of Public Health found out of 32 of the most common antibiotic-prescribing scenarios, 10 had surplus doses left over and 18 had a dosage shortfall, leaving only 4/32 scenarios when the packaging size matched exactly the recommended dosage guidelines.
This is certainly an area where pharma packaging can help by ensuring labelling information corresponds accurately to the latest guidelines. Labelling guidelines also must keep up with wider health trends, such as the continued rise in child and adult obesity, which render recommended dosages outdated very quickly.
Developments in digital packaging technologies are also helping pharmacists and doctors on the frontline monitor usage data and get a clearer picture of compliance trends. “Smart” blister packs are becoming more advanced, utilising built-in microchips to capture use-related data and remind patients when the next dose is due. The data collected from these packs can then be accessed by health professionals to give a clear picture of a patient’s medicine-taking behaviour at home.
Over the next five years, the integration of more advanced digital features into the packaging and delivery systems of antibiotics will become the norm.
Tackling pharmaceutical wastage
According to the UN, the release of antibiotics into the environment is accelerating bacterial evolution and the emergence of more resistant strains.
While the aim of the pharmaceutical industry is to improve public health (while of course turning a profit), a failure to address the environmental impact of antibiotic pollution is undermining efforts. Only recently, The Bureau of Investigative Journalism reported none of the 18 big pharma companies polled would reveal how much antibiotic discharge is released from their factories.
As pharmaceutical waste includes degraded and contaminated products, pharma packaging can play an important role.
In the pharma industry, innovation has always been synonymous with new drug discovery and approval. However, while there’s no arguing about the importance of new antibiotic development in the fight against AMR, the next generation of packaging and delivery systems deserve the same attention.
With AMR placing increasingly complex demands on the supply chain, packaging and delivery components must be precision engineered to ensure antibiotics are delivered and administered to patients as intended. This involves the mass adoption of Quality by Design (QbD).
The underlying principle of QbD is that quality is built into a product from the outset rather than tested during manufacture. Knowledge-based design has a key role to play in establishing “the rulebook” about how a multitude of factors impact safety, efficacy and patient experience.
Poor quality medicine
A sufficient dose of the right antibiotic medicine early on in an infection will kill susceptible strains and help suppress newly-mutated pathogens from spreading. However, if the medicine being relied upon is poor quality or falsified, the whole treatment process is undermined.
Currently, the sale of counterfeit pharmaceuticals is the world’s largest fraud market, worth more than $200 billion per year. However, digital packaging solutions are offering greater supply chain visibility and making falsification harder.
Digital mass serialisation is becoming a popular solution to combat counterfeiting. This involves the generation of a random, pseudo code in a sequential manner by a technology provider entered into their or their customers’ database for later verification. The authentication process matches the unique code on a product to those stored in the database. If the code is present, the product is deemed to be genuine.
Origin has developed Smart-i PharmiTrack technology for the control of physical products in the supply chain and can be applied to any size of batch or even to a single unit measure. This technology can identify the security status and location of your product remotely, at any time, making attempt to seize or introduce falsified medicines into the supply chain much more difficult.
AMR is a complicated and multi-dimensional issue, requiring the collaboration of national governments, NGOs, scientific experts and the general population to solve.
While pharma packaging cannot claim to offer the solution to the AMR crisis, at this point, every stakeholder in the healthcare supply chain has a responsibility to play their part.
What is a terrifying threat may also be an opportunity to drive “health for all” across the world, balancing the many economic, social and health inequalities which continue to exist today.
Origin’s World Antibiotic Awareness Week Explainer Video
World Antibiotic Awareness Week | Antibiotic Resistance | Antibiotics | World Health Organisation - YouTube
It’s very easy to go about your day to day life without thinking about the impact the products you buy and use have on the environment. Although there has been a surge in interest in single-use plastics, the reality is that many of us aren’t aware of the damage we’re doing to the planet. Every day, we use items and dispose of packaging, which may well be made from unsustainable resources and could end up in the ocean. Packaging is a problem, so what can we do about it? Pharmaceutical companies are participating in a wider effort to minimise waste, invest in sustainability, and develop new materials, which are more environmentally-friendly. This guide will provide information about the risks posed by packaging and details about how companies are changing the way they work to protect the environment.
Packaging and the environment
We come across a variety of packaged products every single day. From cartons used to contain milk and cereals, to medicine bottles, drinks bottles, food containers and packaging wrapped around clothing, we’re exposed to all kinds of different materials on a daily basis. Today, more and more of us are taking an interest in how our lifestyles and the products we consume impact the environment. Recently, there has been a noticeable shift in attitude towards single-use plastic, largely due to the popularity of David Attenborough’s Blue Planet documentaries. Heart-breaking images of turtles trapped in plastic netting and whales trying to eat plastic containers made us all stop and think about what we’re doing, and how we can make changes. The Blue Planet series drew attention to ocean pollution, a problem many of us may not have been aware of before viewing the BBC footage. It’s well-documented that plastic can’t just disintegrate into the ether, but perhaps we were naive about how much ends up in seas and oceans. It’s virtually impossible to put an exact number on the amount of plastic that ends up in the water every year, but scientists estimate that the figure tops 8 million metric tons. This equates to around 10 percent of the total amount of plastic we produce.
It’s clear to see that packaging, most notably, single-use plastic packaging, is a problem, but why is it so detrimental to the environment? Plastic harms the ocean environment, but it also has an adverse effect on wildlife. Research conducted by the Ocean Conservancy shows that plastic traces were identified in 100% of turtle species and 60% of seabird species.
What are pharma companies doing to protect the environment?
Pharmaceutical companies are leading the way in adapting the way they work to benefit the environment and reduce the risk of harming the planet and its native wildlife species. There are numerous ways in which pharma firms are making an effort to protect and preserve the planet.
Focusing on sustainability
Investing in sustainability is a positive step forward for pharmaceutical companies in terms of waste reduction and lowering the detrimental impact of certain materials. Companies that are actively looking for sustainable ways of producing packaging are turning their attention to developing materials that are either reusable or recyclable, reducing the amount of packaging required, encouraging consumers to use packaging more than once and limiting the amount of waste produced throughout the supply chain. Consider the impact of buying and using a cup or flask made from sustainable materials compared to buying a bottle of water every day. This is the kind of model pharma companies are working on. By utilising materials that can be used again and again, this eliminates the need for single-use plastic, contributing to significant waste reduction. It also lowers the risk of medicine bottles, tablet pouches and bottle tops ending up in our oceans. Using sustainable materials enables firms to develop and sell products contained within eco-friendly packaging. If you think that over 40 percent of adults in the UK take prescription medication, and this doesn’t include items that you can buy over the counter, there’s huge scope to make a difference in this industry.
Developing new, more eco-friendly packaging materials
For many years, the same materials have been used to create both external and primary packaging. Now, as pharmaceutical companies strive to do their bit to protect the environment, many are focusing on developing new, more eco-friendly packaging materials. Firms are looking for sustainable materials, but they’re also sourcing and researching materials that have a much less harmful impact on the planet. Examples of materials that are now used by pharma businesses include:
PE or PET: this is a material made from sugarcane. The process involves extracting ethanol from sugarcane and dehydrating it to create ethylene. The ethylene is then converted into PE or PET at a polymerisation plant.
PCR (post consumer regrind): PCR products are made using plastic that has already been recycled. The theory lies in the fact that recycling more plastic reduces the demand for new plastic.
PLA (polylactic acid): PLA is made from renewable materials, including corn starch.
Biodegradable materials: one of the main issues with plastic is that it takes hundreds of years to break down. As a result, identifying biodegradable alternatives is likely to make a huge difference. The aim is to replace traditional plastics with biodegradable materials that do the same job, but decompose much faster.
Developing eco-friendly materials is not the only means of reducing plastic waste. Pharma firms are also researching and working on design and manufacturing processes that are cleaner and more environmentally-friendly.
The benefits of using sustainable packaging
Using sustainable packaging offers mutual benefits for businesses and customers. It is evident that people are concerned about the environment, and as a business owner or leader, it’s important to respond. Changing the way you work could enhance your brand reputation, and encourage customers to choose your business over others as a result of the work you’re doing to protect the environment and promote greener living. As well as creating a positive impression, switching to sustainable resources could also reduce costs, as smaller quantities of materials will be required to produce packaging. Many companies have also started to clamp down on unnecessary packaging. If you send out products with excessive packaging, you may find that going green saves you a substantial amount of money.
Reducing the carbon footprint
The carbon footprint is a measurement of emissions, which is produced both indirectly and directly by a single person, a household, a business, a country or an event. If you have a point of origin, a mode of transport and a destination, you can work out your carbon footprint when transporting a batch of products, for example. Pharmaceutical companies can reduce their carbon footprint by streamlining supply chain processes, improving energy efficiency and investing in advancements, which lower energy usage. There are also options such as using eco-friendly vehicles to transport goods and encouraging employees to participate in green commuting schemes.
Other industries looking to make a difference
Changes are afoot in the world of pharmaceuticals, as more and more companies look to adopt eco-friendly ways of producing, distributing and selling products, but this is not the only industry hoping to make a difference.
The food industry is one of the leading producers of plastic waste. You only have to take a look around you in supermarkets or convenience stores to see that the vast majority of edible products are packaged using plastic. Despite the fact that many items are recyclable, the vast majority end up in landfill sites. It is estimated that more than 50 billion bottles of water are purchased each year, and only 20 percent are recycled. Food packaging firms and manufacturers are making an effort to reduce waste by using less plastic and reducing the size of cartons and containers, and they’re also looking to use alternative materials, including graphene. Most of us will also have noticed that shops have stopped giving out free plastic bags. According to the Department for Environment, Food and Rural Affairs, the number of plastic bags provided by England’s seven leading supermarkets dropped from over 7 billion per year to 500 million in the first six-month period following the introduction of the 5p bag charge.
The fashion industry is also addressing the problem, with many brands signing up to initiatives that are designed to target microplastics, including switching to recycled materials such as plastic, polyester, and polyamide.
There’s no doubt that many of us have more become more conscious of the environmental impact of our day to day lives. Jaw-dropping images featured in Blue Planet II provoked a national response, and even David Attenborough admitted that he had been bowled over with the scale and conviction of the reaction. Businesses can benefit from growing consumer interest in eco-friendly products and packaging. By investing in sustainable materials, reducing waste and adopting greener ways of working, companies aren’t just doing their bit for the planet and cutting costs. They’re also endearing themselves to consumers who want to make a concerted effort to switch to a more eco-friendly lifestyle. For pharma companies, alternative therapists and health professionals looking to make a difference, working to protect the environment makes perfect sense.
GSK, Bristol-Myers Squibb, Novartis and AstraZeneca to name but a few are investing billions of dollars in biologics to have prime mover advantage in a market forecast to be worth nearly $480 billion by 2024.
It’s clear biologics are the future of medicine based on their proven ability to treat major chronic diseases better than existing alternatives. This, combined with an aging population, is driving exponential growth in the global biological drugs market.
This all sounds extremely promising, but the rapid rise of biologics has thrown up huge challenges for packaging to deliver safe and effective products. If these aren’t overcome, we risk halting progress on these groundbreaking new treatments and ultimately, put health outcomes at risk.
Therapeutic proteins are very different from traditional small-molecule medicines. Essentially, biologics are “nano-machines” whose functionality depends on their molecular shape and delicate structure.
Degradation during transport, storage and usage is a large concern. Proteins are very sensitive to metal ions, so a crucial issue that must be taken into account is the accumulation of ‘leachables’ from metals ions found in glass, plastics and rubber.
The current reliance on polyethylenes, polypropylenes and polycarbonates in pharma packaging will mean stakeholders will fail to meet the future efficacy requirements for safe and effective biologic products.
Enter which, due to the elimination of injection molding limitations, product design engineers can now cost-effectively use and maximise its material benefits. Being chemically inert, fluoropolymers form a resistant barrier to eliminate these biodegradation issues. They also don’t use any leachable or degradable stabilizing additives, so even over time, under intense environmental pressures or in the presence of solvents, oils and oxidizing agents, medicines remain stable.
As a less brittle, lighter and more flexible alternative to glass, cyclic olefin plastics are also growing in popularity because, like fluoropolymers, they’re intrinsically very inert, composed of just carbon and hydrogen. Almost all are very rigid thermoplastics which can be injection-molded or extruded to produce a wide-range of packaging items.
These next-generation packaging materials, amongst others, are helping to deliver the next generation of medicines.
Optimal delivery systems
By their nature, biologics are difficult to form into solids or capsules, meaning injection is the most common method of delivery. It’s then, no wonder, the global prefilled syringes market is estimated to be worth $22.5 billion by 2025.
A prefilled syringe is a win-win solution for patients, health professionals and manufacturers as it promotes self-administration, reduces overfill waste and lessens the risk of misuse.
However, while silicon oil, used as a lubricant to help move the plunger in prefilled syringes, are considered non-toxic and biocompatible, there’s evidence from microflow imaging (MFI) that protein aggregation can occur. Therefore, each new compound and packaging solution should be tested for individual compatibility and assessed through different temperature, transportation and time scenarios.
As there are limitations on how rapidly any volume of drug can be injected subcutaneously, there’s also a growing interest in wearable injectors – or on-body delivery devices – to improve biologics’ bioavailability and patient experience.
The most advance on-body systems are helping to improve compliance, increase ROI and lower health system costs associated with large protein biologics. They’re also more comfortable for patients and moves treatment from the hospital into the home.
Apply QbD principles
In the pharma industry, innovation has always been synonymous with new drug discovery and approval. However, while there’s no arguing against the importance of developing new medicines, the next generation of packaging and delivery systems deserve the same attention.
With innovations in biologics placing increasing and complex demands on the supply chain, packaging and delivery components must be precision engineered to ensure these groundbreaking new treatments are delivered and administered to patients as intended.
Like experienced by conventional pharma, there’s a steep learning curve ahead to build transferable knowledge. As our understanding of the fundamentals of biologic behavior grows, so too does the requirement to dig deeper for data to support further progress and inform best practice.
The underlying principle of QbD is that quality is built into a product from the outset rather than tested during manufacture. Knowledge-based design has a key role to play in establishing “the rulebook” about how a multitude of factors impact safety, efficacy and patient experience.
For example, a self-injection system needs to function consistently and reliably for patients using them at home. QbD-designed components can significantly reduce plunger variation, facilitate more efficient manufacturing processes and boost patient confidence. They can also enable larger-size delivery systems and greater dose volumes to encourage accurate self-administration and reduce wastage.
In their infancy, biologics were considered first-in-class and unbeatable. However, the market is now maturing and biosimilars – which have no clinically meaningful differences – are becoming more popular. Players can expect a fiercely competitive playing field.
Buyers now have increasing choice in many areas, such as autoimmune, placing pressure on manufacturers to re-consider packaging performance which has become a key point of difference.
We’re likely to see packaging designs which incorporate smart value-added features to stand out from the crowd. For example, more exclusive deals will be struck to secure access to enhanced delivery devices; vacuum insulated panels added to cut cold chain risks and hibernation capabilities to extend a product’s shelf life if unexpected delays occur.
It’s a testing, yet exciting time, for the pharmaceutical industry. The companies that master the art of delivering biologics in a safe, efficient and convenient way will empower both patients and healthcare professionals with the utmost confidence as they look to treat often life-altering conditions.
As legislation and ethical awareness evolves, Origin Pharma Packaging has seen the demand for innovative design and production of child safe packaging increase on a global scale.
Our new product development (NPD) team are continually investing their time and knowledge developing commercial solutions for child resistant compliant packaging for the UK, Europe, the U.S.A and beyond.
During the past twenty-four months, Origin Pharma Packaging have partnered custom design and manufacturing projects not compatible with the larger manufacturing sites across the HP3 (Hybrid Pharma Packaging) network. As a result, Origin have added a new clean room manufacturing facility to HP3 network, located in Melton, East Yorkshire, UK.
Origin have executed a multi-million-pound investment programme at our Centre of Excellence for Pharmaceutical Packaging Design & Innovation. Installing and delivering a clean room production facility to ISO 7 (class 10,000) or ISO8 (class 100,000) boosting the capabilities of the existing HP3 network. The facility is equipped for the manufacture of Injection Moulded (IM), Injection Stretch Blow Moulded (ISBM) and Injection Blow Moulded (IBM) parts.
Clean room production facility key facts:
Classification: ISO7/ class 10,000 to ISO8/ class 100,000
Compliant to ISO14644 | ISO9001 – ISO 15378 | BRC
Injection Moulding (IM)
Injection Stretch Blow Moulding (ISBM)
Injection Blow Moulding (IBM)
The HP3 network required the addition of this specific facility at a regional level – combining cleanroom classification, multiple ISO and GMP compliance, MHRA pursuit, EUPh compliant raw material sources, custom flexibility and integral supply chain assurance.
Due to the urgency of a sponsor project – a global pharmaceuticals manufacturing company – Origin executed and delivered the clean room production facility within four months. It is now fully functional, and production commenced in Q1 2018.
Watch the transition of the space into a pharmaceutical, clean room manufacturing facility here:
Pharmaceutical Packaging New Clean Room Production | ISO 7/ class 10,000 to 8/ class 100,000 - YouTube
If you would like to receive more information on the clean room manufacturing facility or you have an enquiry regarding a new project, please get in touch today; firstname.lastname@example.org
Meeting in Nairobi in December 2017, the United Nations Environment Assembly committed to a new resolution, urging all countries, ‘to prevent and significantly reduce marine pollution of all kinds, in particular from land-based activities’ by 2025. It claims, unless we take action, our oceans will contain more plastic than fish by 2050.
The call to action is increasing and businesses across all sectors are preparing for the global fight against disposable plastic packaging.
Origin discusses how businesses, particularly the pharma industry, can evaluate current processes to remain both cost-effective and reduce plastic waste.
Alternative materials and technologies
According to the UK Government, plastic waste in the oceans will treble in the next decade, as each piece takes hundreds of years to break down. Of course, it’s the responsibility of businesses to help take action against plastic waste, but this will inevitably cause challenges for the pharmaceutical market.
There is more research taking place around bio-based PE and bio-based PET, as these materials are easily recyclable alongside their conventional counterparts in existing recycling streams. Bio-based PET is made from ethylene derived from sugarcane. Cultivation of sugarcane utilises carbon dioxide and releases oxygen, which means it also has a negative carbon footprint.
Some of the latest applications for alternative forms of plastic include pioneering new technology converting PET waste back into virgin grade material for use. It works by taking non-recycled PET waste — like coloured bottles — and breaking it down to base molecule level, while separating the colour and other contaminants.
The molecules are converted back into PET, which is equal to virgin grade quality. The technology has successfully passed its pilot stage and is now moving towards testing at an industrial scale.
The right design and manufacturing processes can significantly reduce waste and reliance on energy, creating a final product with a lower carbon footprint. As a heavily regulated industry we are not always the best at collaboration, yet there is barely an industry not affected by the cry for alternative materials, so it’s important to focus on developing solutions.
3D printers are cutting back on waste during the R&D stages of pack development, as it slowly adds material to an item until it is complete. Most other manufacturing methods are subtractive, but with additive manufacturing you are building objects from the bottom up and only using the material you need.
3D printing can also accelerate early-stage product development through rapid prototyping. It helps companies design several molds so these can be manufactured quickly and economically. Thus, it can rapidly expedite the time and cost it takes to bring a product to market.
Part of the solution for cutting plastic waste is to reduce the total amount of packaging produced overall. We should focus on optimising the materials we already use alongside technology, which is developing within production processes, to deliver material intelligently within the molding process.
Rheological, thermal and mechanical mold design with the help of a wide variety of software solutions, is part of the answer to reducing waste in the design and processing stages. Furthermore, computer aided design (CAD) and computer aided manufacturing (CAM) allows close tolerances during the mold making stages, which further enhances accuracy.
We also need to look beyond packaging and consider how innovations in formulations and dispensing can reduce the quantity of packaging needed to deliver products.
A good example of this is the innovative tamper-evident design of two-in-one vials for pharmaceuticals. These enable consumers to easily determine the authenticity of a product and takes the guesswork out of mixing drugs, so there is less waste. There is less chance of contamination and it’s a cost-effective solution versus traditional glass vials.
Innovations are occurring across temperature-controlled packaging as well. A standard characteristic is many different dimensions are necessary to account for any change in mass or volume. However, pharma industries are working on solutions which do not require a comparable variety of components and therefore have smaller overall dimensions.
Reshape the materials’ economy… one step at a time
A new report suggests applying circular-economy principles to global plastic-packaging flows could reshape the materials’ economy. It could drastically reduce negative externalities, such as “leakage” into oceans as plastics escape established waste-collection systems.
To create an effective after-use plastics economy, the pharma industry should start to establish a cross-value chain dialogue and industry-wide plastics protocol to substantially improve collection, sorting and reprocessing yields and quality, while allowing for regional differences.
Focus on key innovation opportunities that have the potential to scale up should continue, such as investments in new or improved materials and reprocessing technologies. There needs to be a continued focus on adopting reusable and industrially compostable plastic packaging when possible too.
While there remains a degree of scepticism regarding the detail, nature and geographical source of global plastic waste, there is clearly no time to be lost in addressing the bigger issue. There are aspects to the plastics crisis within our control and opportunities to demonstrate our commitment as an industry and as a nation to lead and pioneer in the realisation of a safer, sustainable environment.