Process characterization is critical to any cell therapy program. Not only are validated processes required to consistently produce safe and effective therapeutics, but developers must also outline ...

ABSTRACT: Pultrusion remains one of the most efficient continuous manufacturing processes for producing high-strength, fiber-reinforced polymer composites. This review examines the pultrusion of ...

Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...

As biologics programs progress toward commercialization, late-stage development introduces distinct challenges—from scaling processes efficiently to ensuring regulatory readiness and maintaining cost ...

Matt Taylor is a senior process development associate at KBI Biopharma, where he focuses on the design, optimization, and scale-up of purification processes for biopharmaceutical manufacturing. Matt ...

Creative Commons (CC): This is a Creative Commons license. Attribution (BY): Credit must be given to the creator. Accurate characterization of charge variants in biologics is crucial to uphold ...

This webcast features: Marc Smith, Lead Product Manager, Process Development, IDBS. In biopharmaceutical development, drug development scientists face increasing complexity in managing data across the ...

This white paper examines how Samsung Biologics and the industry at large apply a quality by design (QbD) approach to technology transfer (tech transfer) and process characterization (PC) for biologic ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...

AI-powered tools are enhancing precision, efficiency, and decision-making in biopharmaceutical development. Recently, Jared Auclair and Anurag Rathore explored AI's evolving role in biopharmaceuticals ...