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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Complex biotherapeutics present unique analytical challenges for developers.
EMA starts review of Sanofi vaccine; Regeneron's EUA expanded
Public-private consortium is tasked with advancing domestic pharmaceutical production.
New biotherapeutics both drive and benefit from innovative development technologies.
August 03, 2021
Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.
FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.
FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.
The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.
DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
Dosage form priorities are shifting to focus on user-friendliness, leading to greater engagement with outsourcing partners earlier in development timelines.
Amorphous solid dispersions can overcome the pH effect encountered with oral oncology medications.
A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.
Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.