“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

Considering current developments in Alzheimer’s drugs, a US expert has predicted that the industry should “be prepared for more complex biological therapies that require intravenous infusion and vigilant monitoring for side effects; more like cancer therapies,” according to Dr Jeffrey Cummings, Alzheimer’s clinician-scientist and research professor at the School of Integrated Health Sciences, University of Nevada, Las Vegas. “eight of the drugs with reported data from Phase II for this year are all anti-inflammatory drugs” Notably, “eight of the drugs with reported data from Phase II for th ..read more

Research on the global pharmaceutical parenteral packaging market by InsightAce Analytic Pvt. Ltd. has predicted that the sector will value $18.85 billion by 2031. This is aligned with a CAGR of 4.47 percent between 2024 and 2031. Main drivers for the market were reported to be rising popularity of generics together with blockbuster and other small-molecule drugs going off-patent globally. Overall, increasing demand for generic medicines will be a significant factor for growth. Additionally, advances in technology and a rising prevalence of chronic diseases were described ..read more

Four key barriers to female career progression were explored during a panel at the UK 2024 Advanced Therapies conference in March. Hosted by members of the professional women’s networking group CGT Circle, the session explored factors that could be contributing to the current imbalance for women in leadership positions within the cell and gene therapy (CGT) sector. For example, a survey published by the organisation for this year’s International Women’s Day found that 47 percent of women are paid less than their male counterparts.1 The four key challenge areas1 highlighted in the session ..read more

Researchers have evaluated microbial contamination surface sampling methods to assess the recovery efficacy of naturally occurring microbe-carrying particles (MCPs). Sterile tryptone soya agar 55mm diameter tryptone soya agar RODAC contact plates were used in the investigation. Three different manual sampling methods were tested on contaminated hard surfaces containing MCPs dispersed from a person within heavily populated environments. Eaton et al. stated that they aimed to determine “a convenient manual sampling procedure that can be routinely used to provide more consistency of practice”. C ..read more

in clinical trials [the combination treatment was shown] to halt tumour growth for low-grade gliomas for an average of more than two years” The National Institute for Health and Care Excellence (NICE) has recommended a new targeted drug combination treatment for young people with BRAF V600E mutation-positive glioma. Dabrafenib (Finlee) in combination with trametinib (Spexotras) is indicated for patients aged one and over, based on the agency’s proposal in its final draft guidance.   The combination of medicines, both made by Novartis, have demonstrated in clinical trials an abilit ..read more

New trial data for a gene therapy presented at the International Myology 2024 Congress has revealed “good” tolerability in Duchenne muscular dystrophy, when combined with transient immunological prophylactic treatment, as well as efficacy data relating to microdystrophin expression and functional improvement. The gene therapy trial for GNT0004 enrolled ambulant (able to walk) boys six to 10 years old, Genethon stated. The innovative design incorporated Phases I/II/III trials conducted with a dose escalation phase, followed by a pivotal phase at the selected dose. To treat this rare disease, G ..read more

A study published by Japanese researchers explores the correlation between particles generated by operators and airborne bacteria, utilising biosafety cabinets within a typical laboratory setting. The research was published in Regenerative Therapy. To protect cell therapy products from risks of contamination by bacteria present in cell-processing facilities along with bacteria and fungi in raw materials, manufacturers must establish a cleanroom environment and sterile production area, the paper states.  This aseptic production area is regulated through environmental monitoring, including ..read more

Bristol Myers Squibb (BMS) and Cellares have announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies. The deal is valued at up to $380 million in upfront and milestone payments. The agreement will see BMS use Cellares’ fully automated cell therapy manufacturing platform for the clinical and commercial-scale manufacturing of select CAR T cell therapies. Cellares will optimise, automate, and tech-transfer select BMS CAR T cell therapies onto its cell therapy manufacturing platform, the Cell Shuttle. The company will also dedicate multiple syst ..read more