William Garden

Placeholder Person Graphic
Amgen, Inc.
Director of Regulatory CMC
William Garden has been with Amgen, Inc., for more than 25 years in a variety of roles in QA/QC, validation, and compliance. For the last 13 years, he has worked in regulatory affairs-CMC, where he is currently Director of Regulatory CMC, managing postapproval variations and life-cycle management for about 10 commercial products.

Related Articles

Rapid Filter or Resin Change Strategies for Biomanufacturing
Technical
Rapid Filter or Resin Change Strategies for Biomanufacturing

Pandemic-related supply chain shortages have placed constraints on the supply of essential filters and chromatography resins. An agile regulatory pathway to implement alternative filters and resins into manufacturing is necessary to ensure the continued supply of approved biologics. To allow this in the US and potentially globally, the regulatory strategy proposed in this article is to provide...

Regulatory Landscape for Raw Materials: CMC Considerations
Features
Regulatory Landscape for Raw Materials: CMC Considerations

A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...