Small biotechs in early development of cell therapies are often surprised by the strictness of commercial manufacturing standards. That’s the view of Luděk Sojka, PhD, CEO of contract developer and ...

As part of its next phase of growth, Xcellon Biologics appointed co-founder Abhishake Chhibber as Chief Executive Officer to lead the company’s transformation into an end-to-end CRDMO for ...

An adenoviral process that works for one construct can fail with the next. A harvest step optimized in development can erode yield at scale, and an early analytical method can stall a program at ...

Exogenus Therapeutics and Lonza agreed to collaborate on the development of Exo-101, Exogenus’ exosome-based lead candidate. The company specializes in the development of therapeutics based on ...

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Process Validation with Qualification (June 3rd - June 4th, 2026)" training has been added to ResearchAndMarkets.com's offering. Ensure your ...

NEWARK, Del., July 15, 2026 /PRNewswire/ -- Recently, ACROBiosystems has officially received the "Material Suitability Confirmation for Regenerative Medicine Products" (Certificate No.: 薬機審長発第47号) ...

Bio: Mary Kay Bates is a Senior Global Cell Culture Scientist with Thermo Fisher Scientific, where she provides cell culture expertise to colleagues and customers. Her knowledge is based on twenty ...

Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. The Therapeutic Goods Administration (TGA) of Australia has released guidance and a web-based tool to ...