In a rapidly changing healthcare landscape, in which biologic therapies are becoming increasingly prevalent, Amy Karren’s knowledge and professional experience will be invaluable in informing USP’s strategy to support for the quality of biologics and other innovative therapies.
An accomplished expert in microbiology and sterilization, Amy has led laboratory operations and contributed extensively to the development of industry standards. Her expertise includes oversight of controlled environments, sterilization, test methods, and contamination control – all of which are critical to ensuring the purity and safety of medicines.
Amy has been a member of the USP Council of Experts for two cycles and has been a leader in international working groups that have helped shape quality standards across products and testing systems globally. She served as Chair of the Nominating Committee for the Council of Experts for the 2025-2030 USP cycle. Her knowledge of USP and leadership experience will be assets as she embarks on her new role as At-Large Trustee on USP’s Board.
Career Highlights:
- Nelson Laboratories: Director of Scientific Development, Microbiology Section Leader, Study Director for Bacterial Endotoxins Testing, Bioburden, and Environmental Monitoring
- W.L. Gore and Associates: Microbiologist, Sterilization Microbiologist, Sterility Assurance Process Champion
Education:
- Utah State University – B.S., Biology
- Humboldt State University, Special studies in marine biology
Awards, Recognition, Admissions:
- AAMI Standards Developer Award
- USP Jacob Bigelow Award
- Convenor, ISO TC198 – WG8 – Microbiological Methods
- U.S. Delegate, ISO TC198 – Sterilization Standards Committee
- Co-chair, AAMI TC 198 – WG8 – Microbiological Methods
- Specialist and Registered Microbiologist (American Academy of Microbiology) – Pharmaceutical and Medical
- Device (RM)/Specialist in Microbiology (SM) [National Registry of Certified Microbiologists (NRCM)]
- Chair, USP Expert Committee 5, Chemical Medicines
- Member, USP Expert Committee, Small Molecules
- Member, USP Advisory Panel Member for USP <81> Antibiotic Potency
A Few Favorite Professional Achievements:
- Designed, developed, and validated a new standard test procedure for determination of objectionable organisms in human tissue proposed to be made an American Association of Tissue Banks (AATB) standard test procedure.
- Pioneer and thought leader for bacterial endotoxin testing (BET).
- Author/co-author of multiple industry standards and published articles.
