Establishing quality assurance in personalised preparations
A paper has highlighted a drug product quality assurance programme for personalised preparations, including application of a preventive or corrective measures (CAPA) system.
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A paper has highlighted a drug product quality assurance programme for personalised preparations, including application of a preventive or corrective measures (CAPA) system.
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
Autonomous biologics manufacturing with process analytical technology (PAT) “opens up a new frontier for aqueous two-phase extraction (ATPE)" in this sector, according to research.
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
Research predicts the pharma quality management systems (QMS) market will grow significantly in the next several years and is projected to value $3.97 billion by 2030.
Lonza’s Associate Director of R&D has offered insight on implementing process analytical technology (PAT) into biologics manufacturing using real-world examples.
12 July 2023 | By Altasciences
Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
Parenteral Drug Association (PDA)'s 2023 technical report on nonconformities in glass containers during pharmaceutical manufacturing represents best practices for identification and classification.
Phage therapy holds great promise as a new therapeutic option in the face of increasing antimicrobial resistance, but sound clinical data remains a stumbling block to its application. Here, Snehit Satish Mhatre from Eurofins Biopharma Product Testing outlines key considerations to address when designing clinical trials.
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.