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

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

The European Commission (EC) has granted marketing authorisation for the first EU-approved β-lactam/β-lactamase inhibitor antibiotic combination as a treatment for serious infections in adults caused by multidrug-resistant Gram-negative bacteria. EMBLAVEO ® (aztreonam-avibactam) is indicated for adults with complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP). This includes ventilator-associated pneumonia (VAP) and complicated urinary tract infections (cUTIs). The combination treatment is also approved for adults with limited treatment options who have infe ..read more

Researchers have developed and validated a rapid, sensitive, precise ultra high performance liquid chromatography (UHPLC) method for dual determination of the type 2 diabetes drugs, teneligliptin and pioglitazone. According to the paper, Kolhe et al. wanted to ensure the UHPLC method offered improved resolution and peak symmetry, while adhering to ICH validation guidelines. The researchers proposed the technique for both pure and pharmaceutical formulations. the UHPLC method offers speed, convenience, precision and accuracy…[and is] considered more cost effective as compared to other reporte ..read more