Newsletter | December 17, 2025
BEST OF FROM THE EDITOR
1.
The FDA 483 Heard Round The World
2.
Will It Not Die? The BIOSECURE Act Back With Iterations
3.
CDMOs Should Stop Stringing Biotechs Along
4.
Did Trump Just Create An Antibiotic Supply Chain In The U.S.?
5.
A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing
6.
Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection
7.
As Billions Of Dollars Pour In, Do CDMO Valuations Matter?
8.
Tech Transfer 2025 – A High-Stakes Game Of Trust
9.
Paying For Lots Of Formulation Work At Your CDMO
10.
The 15% Tariff: A Modest Jolt Or Deeper Disruption?
BEST OF INDUSTRY INSIGHTS
Creating A Compliant And Scalable CGT Logistics Launch Plan
By Cencora
Revolutionizing Viral Vector Production With Intensified Cell Culture
By Junwei Sun, Dr. Lucia Fernandez, and Matthew Ercolino, VintaBio
How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls
By Brandon Haigh, Minaris Advanced Therapies
De-Risking Cell Therapy Development: 4 Keys To A Streamlined IND Path
By Dr. Bruce Thompson, Kincell Bio
Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends
By MasterControl, Inc.
Phase-Appropriate Approaches To Manufacturing And Testing
By Aldevron
Emerging Vaccine Technologies
By FUJIFILM Biotechnologies
Developing Scalable, Global Solutions For Cell & Gene Manufacturing
By Novartis Contract Manufacturing
Put Your AAV On The Fast-Track To The Clinic
By Catalent
4 Key Autologous Manufacturing Challenges (Plus How To Solve Them)
By Dawn Maier and Jeff Cram, ElevateBio
BEST OF SOLUTIONS
Advanced iPSC Workflows: Accelerating Cell Therapy Development
Catalent
Pharmaceutical Change Control Software
MasterControl, Inc.
Groundbreaking Cryogenic Freezer Technology
Cryoport Systems
Advancing Vaccines From Preclinical Development To Commercial Supply
FUJIFILM Biotechnologies
Future-Ready Development
Landmark Bio
RNA Therapies
Recipharm Advanced Bio
Capabilities Update January 2025: Cell & Gene Therapy
Andelyn Biosciences
Quality GMP-Grade iPSC And Knockin-Ready TARGATT™ iPSC
Applied StemCell
Allogeneic CAR-T Cells
Excellos
Quality Risk Management Software
