Newsletter | December 18, 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.
Did Trump Just Create An Antibiotic Supply Chain In The U.S.?
4.
Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection
5.
A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing
6.
Tech Transfer 2025 – A High-Stakes Game Of Trust
7.
Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.
8.
Will It Not Die? The BIOSECURE Act Back With Iterations
9.
How A Biotech Navigates the CDMO Frenzy For GLP-1 Services
10.
The Key To Outsourcing Is Timing-lines, Not Timelines
BEST OF GUEST COLUMNS
Navigating Contract Manufacturing Agreements: Tips And Pitfalls For Pharma And Biopharma Companies
By Robert Paradiso, partner, Lowenstein Sandler LLP
Are You Still Evaluating CMOs When You Really Need A CDMO?
By Ivan Di Bonaventura
How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage
By Kieran Falvey, Pharmalliance Consulting Ltd.
Defining Strong Program Management In CDMO Partnerships
A conversation with George Stephen, director of global program management, Gilead Sciences
Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs
By Ruba Asmussen, founder and CEO, RTA Consulting
BEST OF INDUSTRY INSIGHTS
Step-By-Step Guide To Tech Transfer Preparation And Execution
By Joseph Longworth, Jubilant HollisterStier
Why Project Management Is Essential To CDMO Partnerships
By Upperton Pharma Solutions
Is Lipinski's Rule Of Five Still Relevant In Drug Development?
By Dave Miller, Ph.D., AustinPx Pharmaceutics and Manufacturing
Target Product Profiles And Phase 1 Clinical Plans: Laying The Groundwork For Success
By Dr. Brett Wagner and Dr. Peter Surman, Douglas CDMO
Human Factors Testing: Engaging End-Users In Med Device Development
By West Pharmaceutical Services, Inc.
Design Of Experiments Approach To Enabling Studies For Process Validation
By Matthew Schiesher, Ph.D., Research Fellow, Cambrex
Friendshoring: A Strategic Shift In Pharma Supply Chains
By Bora Pharmaceuticals
Pressure Testing Your Readiness To Ensure GMP Batch #1 Success
By MilliporeSigma
Novel Applications In Pharmaceutical Spray Drying
By Catalent
Using Synthesis And Route Design Technology To Approach API Complexity
By Dr. Ryan Littich, Lonza, and Dr. Juergen Swienty-Busch, Elsevier Information Systems
BEST OF SOLUTIONS
Emerging Trends In The CDMO Landscape
Bend Bioscience
Best-In-Class Nanodevelopment Capabilities
Nanoform
Regulatory Starting Materials (RSMs) — India
Pharma Expanse
Formulation Development
Upperton Pharma Solutions
Highly Potent API (HPAPI) Handling
Altasciences
Nitrosamines Capabilities
Cambrex
Capabilities Update October 2025: ADC
Simtra BioPharma Solutions
Container Closure Integrity Testing
Lonza
Comprehensive Regulatory Support
Douglas CDMO
Formulation Development: Science, Strategy, And Smarter Solutions
Singota Solutions
