Newsletter | April 25, 2026
FOCUS ON OUTSOURCING
Why A Cell Therapy CEO Waited Until Phase III To Outsource
By Louis Garguilo, chief editor, Outsourced Pharma
Smarter Manufacturing Pathways To Scale In Cell And Gene Therapy
By Jennifer Cannon, Thermo Fisher Scientific
The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells
Applied StemCell
Precision Control In Animal‑Free Raw Materials
Nu-Tek Biosciences
Development Strategies For Adenovirus-Based Gene Therapies
By Eva Fong and Ayan Dey, MilliporeSigma
Solving The Sequencing Puzzle: Speed, Cost, And Quality
By Adriana Geldart, Ph.D., ElevateBio
What Are The Keys To Making Rare Disease Drug Development Sustainable?
Vector BioMed
Streamlining AAV And LVV Manufacturing Platform Solutions
AGC Biologics
FOCUS ON MANUFACTURING
All The Ways Global Biopharma Still Grapples With Annex 1
A conversation with Franck Bure, Genentech/Roche
Mastering Biotech's Insourcing/Outsourcing Trade-Offs
By Andrew Knappenberger, Ph.D., Somatek
Scale Engineered Cell Expansion With Closed Systems
By Ho Yoon Khei, Jun Yung Woo, and Khang Luu, Corning Life Sciences
Assessing Particle Generation In A Single-Use Mixing System
By Hohoud, Cytiva
Transform Monocyte Based Cell Therapy Manufacturing Via Elutriation
Invetech
Preserving Genomic Data's Living Legacy
By Robert Snyder, Ph.D. and Rob Fannon, Precision for Medicine
Controlling Protein Aggregation In Large Volume Freezing
By Mike Marciniak, Single Use Support
6 Tips For Designing A Single-Use Manifold For Advanced Therapies
By Jay Collins, and Chris Hofmann, Charter Medical
The Strategic Benefits Of Isolator Lines In Manufacturing
IDT Biologika
Essential Strategies To Unlock The Full Potential Of Your IVT Manufacturing
Roche CustomBiotech
Towards A More Predictive Model Of Human Biology: A Fireside Chat
Emulate
Tackling CGT Challenges: Solving Scalability Gaps With Stirred-Tank Bioreactors
Eppendorf SE
Key Considerations When Transitioning Research To GMP Production
3PBIOVIAN
Next-Generation CRISPR Approaches
Aldevron
AI And Digital Maturity In Contract Development And Manufacturing
MasterControl, Inc.
Built‑In Quality For Audit‑Ready Manufacturing
By Melodie Bryce, Kincell Bio
Rapid Path To FDA Approval For Gene Replacement Therapy
Andelyn Biosciences
Enhancing Stability With Frozen Starting Materials
Cryoport Systems
A CRDO Method To Faster Biologic Development
Dr. Ivonne Stelzl and Dr. Matthias Lucke, Coriolis Pharma
Powering Cell Therapy Access: Louisville, KY's Unique Position
Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises
Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids
By George Buchman and Bhargavi Kondragunta, Catalent
FOCUS ON REGULATORY & COMPLIANCE
From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
By Gautam Shah and Ajay Babu Pazhayattil, Ph.D.
Navigating Ethical Oversight In Neurological Gene Therapy Research
BRANY
Ex-Regulator's View On Small Surface Contamination Control
By Matt Cokely and Philip Rose, Ecolab Life Sciences
Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment
Cytiva
NGS Analysis Of Hereditary Cancer Predispositions
Agilent Technologies
A New Approach To Isolator Decontamination
AST
Frameworks For Effectively Procuring Labeling Systems
HERMA
The Ultimate Checklist For Cleanroom Project Success
By Trista Hager, AES Cleanroom Technology
Optimize Salt-Active Enzymes For Efficient DNA Clearance
By Joanna Niska-Blakie, QIAGEN
How Emerging Technologies Are Challenging Traditional IRB Oversight
Managing E&L Risks In Single-Use Advanced Therapy Manufacturing
BioPhorum
Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint
Contec, Inc.
Your Go To Fluorochrome And Laser Reference Guide
BD Biosciences
FOCUS ON SUPPLY CHAIN
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
By Mathini Ilancheran, Beroe Inc.
Understanding The Cold Durability Performance Of Fluoropolymer Bags
W.L. Gore & Associates
FOCUS ON CLINICAL TRIALS
CNS Trials Are Difficult — Do They Have To Be?
By Francesco Bibbiani and Marty Kraut, Ph.D., Avance Clinical
Reducing The Burden Of Patient Retention And Improving Continuity
MRN - Medical Research Network
Clinical Research Update: The New FDA Form 1572 is Available
Univo IRB
Establishing Hydrogels In Lab Robotics
Biorasi
5 Dysfunctions Of Vendor Selection And How To Overcome Them
By Kalyan Obalampalli, ClinAI
Specialized Site Network For Early-Phase Oncology Success
Worldwide Oncology
Navigating The Enrollment Bottleneck In Early Oncology Trials
CHDR
How To Write Effective Clinical Regulatory Documents For Therapy Trials
By Robin Johnson and Molly Shea, inSeption Group
