The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023. Following publication of this white paper, the government requested that the MHRA outline the steps the agency is working on in relation to its expectations. Over the past year, MHRA asserted that it has taken “significant steps” to adopt these recommendations. According to the MHRA, artificial intelligence offers “improved efficiencies”, enabli ..read more

A new state-of-the-art research and laboratory building is being built on AbbVie’s main campus at its Rhineland-Palatinate site, the company’s second largest research and development (R&D) location globally. The central research building LUdwighafens neue Arbeitswelt (LUnA) will benefit from an investment of approximately €150 million. Currently, the Rhineland-Palatinate site has over 2,000 employees, and LUnA will house over 300 researchers and scientists, according to AbbVie. The facility will feature modern, sustainable infrastructure. Additionally, flexible working conditions will “en ..read more

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made. The Centre for Process Innovation (CPI), academia, and the pharma industry will work together to develop the model which will harness artificial intelligence (AI), machine learning (ML) and the Internet of Things (IoT). These technologies could enable pa ..read more

The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A. Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B. Recommendations for new cancer treatments The committee also adopted a positive opinion for Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer in adults. If approved, fruquintinib could p ..read more

Researchers in Germany have developed an technique to increase the speed of spectroscopic analysis, which typically takes from minutes to hours to acquire measurement. [the technique] can greatly accelerate data acquisition in ultrafast spectroscopy, particularly in higher-dimensional analyses” According to the paper published in the Journal of Ultrafast Science, the innovative technique “can greatly accelerate data acquisition in ultrafast spectroscopy, particularly in higher-dimensional analyses, by data volume minimisation, signal acquisition time reduction, and a contraction in the requ ..read more

The World Health Organization (WHO) has published a new draft guidance on mitigating nitrosamine contamination in pharmaceutical products. Manufacturers of excipients and APIs should be compliant with relevant WHO good manufacturing practice (GMP) guidelines” One of the key recommendations described the actions manufacturers should take upon identifying a case of nitrosamine contamination that is above acceptable limits. “Risk and impact assessment should be done with root cause determination”, alongside investigation to determine whether shared facilities, equipment or other batches have b ..read more

Researchers have reported a novel universal fungal identification method called Analysis of whole GEnome (AGE) for “the first-time demonstration of the identification potential of sequences from unannotated genomic regions”. Developing new approaches for microbiological identification across the entire fungal kingdom remains “a major challenge”, Qi et al. explained. The AGE technique utilises bioinformatics analysis and technique development for specific target detection. According to the paper, a key aim of the study was to evaluate how well AGE could differentiate between O. sinensis&n ..read more

The Cell and Gene Therapy Catapult (CGT Catapult) has appointed three new Non-Executive Directors to its board. This supports the organisation’s mission to advance the industry in the UK and facilitate wider adoption of advanced therapies. Dr Jim Faulkner is an “experienced, innovative biopharmaceutical development leader with specialist skills in cell and gene therapy”, according to CGT Catapult. He has had “significant involvement” in over 25 therapeutics which have reached the clinic. These treatments include several gene therapy and CAR-T assets. CGT Catapult’s new board appoint ..read more

“approval [of Pyzchiva® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva® (biosimilar ustekinumab). Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine. It is approved for autoimmune disorders within disease areas such as gastroenterology and dermatology. “This approval is a crucial step towards offering European patients an additio ..read more

A study has determined that for biologics subject to multiple stresses during bioprocessing and manufacturing, “exposure to air-liquid interfacial dilatational stress is the predominant mechanism impacting protein particle formation, [both] at the interface and in the bulk solution”. Researchers established a “unique” set-up using a peristaltic pump and a Langmuir-Pockels trough to study the impact of hydrodynamic shear stress due to pumping and interfacial dilatational stress, on the formation protein particles. The set-up was tested on an “industrially relevant [immunoglobulin G] (IgG) [mon ..read more