Newsletter | December 16, 2025
BEST OF FROM THE EDITOR
1.
The FDA 483 Heard Round The World
2.
What FDA's Complete Response Letters (CRL) Say About Outsourcing
3.
Will It Not Die? The BIOSECURE Act Back With Iterations
4.
A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing
5.
Did Trump Just Create An Antibiotic Supply Chain In The U.S.?
6.
Italy A Quiet Outsourcing Standout For Drug Manufacturing?
7.
The 9 Fastest-Growing Outsourcing Segments
8.
We're A Virtual Biotech. CDMOs Should Treat Us As A Priority
9.
Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection
10.
2025 Tariffs Barely Impact Europe's API Supply Chains
BEST OF GUEST COLUMNS
Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter?
By Vadim Klyushnichenko, Outsourced Pharma Board member and VP at California Institute for Biomedical Research (Calibr)
Program Manager Alignment And Integration: Best Practices When Working With A CDMO
A conversation with George Stephen, director of global program management, Gilead Sciences
How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage
By Kieran Falvey, Pharmalliance Consulting Ltd.
What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
By Sarah Sink, Your Pharma Girl
How To Improve Sponsor–CMO Collaboration Around Digital Deviations
By BioPhorum
BEST OF INDUSTRY INSIGHTS
FAQs On The Revised EU GMP Annex 1: Volume 2
By West Pharmaceutical Services, Inc.
Drug Product Process Characterization For Liquid And Lyophilized DP
By Lonza
Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights
By Samsung Biologics
Optimize Your RFP To Ensure Successful Biologic Development
By Mabion
ICH Q14 101: Applying AQbD To CMC For Regulatory Success
By Labcorp Biopharmaceutical CMC Services
ADCs: The Next Phase Of Innovation
By Sophia Shamsi, Hansonwade Intelligence
Liposomes — Challenges And Opportunities
By Pfizer CentreOne
Overview Of FDA's Expedited Program For Serious Conditions
By Pace® Life Sciences
How The Tariffs Could Impact Your Drug Development Supply Chain
By Abzena
The BIOSECURE Act: Implications For US-Based Biopharmaceutical Companies
By Nicolas Schmitz, KBI Biopharma
BEST OF SOLUTIONS
Capabilites Update January 2025: Catalent
Catalent
Formulation And Analytical Tour
Nanoform
Capabilities Update January 2025: Alcami
Alcami
Developing A mAb For A Small Biotech Developing Precision Medicines
Lonza
Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential
Samsung Biologics
3D Modeling Of Facilities With Digital Twin Technology
CAI
Biologics Discovery, Development, And Manufacturing
Curia
Your Innovation, Delivered With Certainty: Leveraging A Leading Global CMDO
Recipharm Advanced Bio
International Supply Chain Management
Singota Solutions
Improving Cell Line Development Efficiency
Abzena
