In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...
The COVID-19 pandemic has emphasized the grave importance of accelerated pharmaceutical development to combat serious or life-threatening diseases and cope with medical emergencies. Image Credit: DSI, ...
The Food & Drug Administration's recent approval of process analytical technology (PAT) for use in the pharmaceutical industry is being hailed by drug manufacturers because it encourages process ...
Gene therapy represents one of the fastest growing biotherapeutics worldwide, with AAV at the forefront. This rapid growth is constantly challenging CMC approaches, from manufacturing through release ...
LumaCyte today announced that its analytical approach has been included in the newly published International Organization for Standardization (ISO) global standard for gene delivery systems, ISO 16921 ...
As lentiviral vector (LVV) programs advance toward larger clinical trials and commercialization, manufacturing platforms and ...
Since 2007, guidelines from the European Medicines Agency and a draft version from the U.S. Food & Drug Administration have called on the drug industry to reduce DNA-reactive genotoxic impurities ...
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