The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, ...

Recent hurricanes in the US close Baxter plant, shining a spotlight on supply chain fragility again.

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry ...

Marianna Tcherpakov, PhD, director of Business Development, CMC Services, at Frontage Laboratories, spoke on the CDMO’s role in tackling complex technical challenges to enable startup biotechs solve ...

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

In this episode of Drug Digest, industry experts discuss the ongoing development of automating biomanufacturing processes, including its challenges and practical applications. The biopharmaceutical ...

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs. In September 2024, the much-anticipated update to FDA’s Guidance ...

Alec McChesney (BD Director, SCORR Marketing) discusses goal setting and alignment between life sciences marketing and business development teams. Alec McChesney sat down with Pharmaceutical ...

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post. FDA’s Patrizia Cavazzoni, director, Center for Drug ...