Newsletter | August 29, 2026
FOCUS ON OUTSOURCING
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
By Devanshi Doshi and Sagi Nahum, CellVira
Overcoming Geographical Barriers In Advanced Cell Therapy Delivery
By Michael Kadan, Vector BioMed
Where Sourcing Meets Science: Smarter Collaboration, Better Outcomes
Nu-Tek Biosciences
Supporting Late-Stage Drug Product Development
Coriolis Pharma
De-Risk Your Combination Product Development
West Pharmaceutical Services, Inc.
Establishing Compliant Facility Operations And Risk Management Protocols
Eurofins
Why Your Bioanalysis Bottleneck Is Costing You More Than You Think
Dash Bio
Redefining The Analytical Frameworks Surrounding Capsid Characterization
By Achille François, Viralgen
Manufacturing Strategies To Industrialize Autologous Therapies
Catalent
Setting A New Standard For Biotech Program Visibility
Andelyn Biosciences
FOCUS ON MANUFACTURING
Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs
By Erin Harris, Editor-In-Chief, Cell & Gene
Bridging The Gap: How Process Knowledge Moves From Lab To Launch
Emerson
Maintain Sterility And Ease In CGT Development, Including Cryopreservation
By Troy Ostreng, CPC Biotech
Data-Driven Bioprocess Development From Molecule To GMP Manufacturing
Eppendorf SE
Protecting Cellular Integrity In Automated Filling Systems
CellBri
Characterizing mRNA Using Ion-Pairing Reversed-Phase LC/MS
Agilent Technologies
Why Freezing And Storage Should Not Be Designed Independently
With Claus Exenberger, Single Use Support
Viral Vector Manufacturing Simplified: A Sponsor's Guide To Smarter Partnerships
By Scott McDaniel, FUJIFILM Biotechnologies
Cell Culture Media Mixing In A Benchtop Single-Use Mixer
Cytiva
Unlock Viral Vector Yield And Efficiency With Upstream Intensification
Repligen
Standardizing Starting Materials For Cell Therapy Production
Terumo BCT
Expanding Pediatric Donor Pools Via Targeted T-Cell Depletion
Miltenyi Bioindustry
Overcoming Key Operational Bottlenecks In Virus Bank Manufacturing
MilliporeSigma
Let's Stop Treating Allogeneic Cell Therapy As One Thing
By Arnaud Deladeriere, Ph.D., Cell & Gene Consulting Inc.
How Equipment Choices Can Help Determine The Pace Of Drug Development
Ensorcell
Tracking Microbial Contamination In Environmental Water
Industry Experts Discuss Solutions To Downstream AAV Barriers
Thermo Fisher Scientific
Detect Rare, Low-Expressing BCMA CAR-T Cells In One Step
By Joseph Cantor, Arthi Kannan, Gary Yao, et al., BD Biosciences
Applying High Throughput Processes To Optimize AAV Titers
By Eva Fong, MilliporeSigma
Automated Workflows That Solve CAR T Manufacturing Complexity
Key Strategies For Scaling MSC Therapies From Early Isolation
By Tom Bongiorno, Whitney Cary, Irana Coletti, et al., Corning Life Sciences
Establishing The First Chinese Haplobank Of Clinical-Grade hiPSCs
Miltenyi Biotec
Using Synthetic ssDNA And dsDNA Templates For CRISPR Editing
4basebio
Predicting The Performance Of Perfusion Media In A Continuous Bioreactor
By Luis G. Rodriguez, Martin Santillan, Catherine Nguyen, et al., FUJIFILM Biosciences
A Closer Look At How Single Use Consumables Drive Cost Per Therapy
Invetech
FOCUS ON REGULATORY & COMPLIANCE
Combination Cell Therapy's Clinical Success Hinges On Manufacturability
By Sanjeev Luther, Ernexa Therapeutics
Key Lessons From FDA 483s For Cleanroom Compliance
AES Cleanroom Technology
Cleanroom Mysteries: What Your Material Transfer Process Isn't Telling You
Contec, Inc.
FDA's Plausible Mechanism Pathway For Personalized Gene Therapies
By Liz Spehalski, Ph.D., and Steve Winitsky, M.D., Parexel International
Containment Performance Verification For Downflow Booth Operations
Esco Lifesciences
Comparison Of Constant- And Pulsed-Field Electrophoresis
By Timothy Butler, Agilent Technologies
Residual DNA Testing Across Biotherapeutics
QIAGEN
Building A New Cleanroom? Here Is A Supplier Audit Readiness Checklist
Ecolab Life Sciences
Transitioning From 2D To 3D: Getting Started With Spheroids
LICORbio
Selecting The Right Quality System For Growing Startups
MasterControl, Inc.
The Alternative Solution To Comply With The New GMP Annex 1
TEMA SINERGIE
Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1?
Understanding And Implementing USP <665> For Single-Use Systems
Solvias
The Importance Of Mycoplasma Testing In Cell Therapy
ACROBiosystems
Lentiviral Solutions: Fast Lane To The Clinic
Aldevron
Optimizing Bioprocess Design And Workflow Orchestration
Revvity Signals Software, Inc.
FOCUS ON SUPPLY CHAIN
What Goes Into Restarting A Shelved Orphan Drug Candidate?
A conversation between Elizabeth White of the Orphan Therapeutics Accelerator and Life Science Connect's Jon O'Connell
Polymer Technology Takes Freeze Containers Beyond The Breaking Point
W.L. Gore & Associates
Assessing The Success Of CRISPR Gene Therapies Using ddPCR Technology
By Marwan Alsarraj, Bio-Rad Laboratories, Inc.
The Psychedelic Setback: What MDMA Rejection Taught Drug Developers
Veristat, Inc.
Decentralized And Community-Based Solutions Driving Women's Healthcare
MRN - Medical Research Network
HRPP Vs IRB: How Unified Research Protections Empower Participants
Univo IRB
