Newsletter | July 14, 2026

07.14.26 -- Moving Beyond Tactical Vendor Selection To Protect Capital Allocations

SPONSOR

CDMO Of The Year: Cell & Gene Therapy

The CDMO Leadership Awards are based on feedback from biopharma sponsor companies and independently analyzed by Tufts Center for the Study of Drug Development. MilliporeSigma is proud to announce their distinction as 2026’s Cell & Gene Therapy CDMO of the year, and best in class distinctions for: Biologics – Technology Use and Cell & Gene Therapy - Analytical Services, Overall Staff, Project Management, Cultural Fit, Technology Use. More.

INDUSTRY INSIGHTS

Navigating CMC Regulation For Plasmid DNA In Gene Therapy

Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

Application Of A Dual Spiking Strategy In Viral Clearance Studies

Assimilate how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.

Redefining CAR-T Speed And Strength: A Conversation

Discover how an autologous CAR-T platform is addressing challenges in cell therapy manufacturing. A three-day process shortens cycles, improves T-cell potency and durability, and reduces costs.

FEATURED EDITORIAL

Moving Beyond Tactical Vendor Selection To Protect Capital Allocations

“My business model when I took over in 2017 was to outsource everything.” That’s as clear as it gets from a biotech CEO. Amit Kumar cuts to the chase during our conversation centered on the newly announced relationship between his company, Anixa Biosciences, and Cytovance Biologics, a U.S.-based CDMO.

Streamlining Post-Approval Changes For Lean Teams

As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.

Leveraging Legacy Chemical Infrastructure For Domestic Supply Security

Well, that didn’t work out as planned, writes Chief Editor Louis Garguilo, referring to Kodak's plan in 2018 to revitalize the Eastman Business Park in Rochester, NY. The incoming chairman and now CEO, Jim Continenza, didn’t like that movie, and flipped the script. Instead, Kodak has, so to speak, returned to itself – back to a domestic specialty materials and chemicals supplier, intent on serving biopharma in that capacity.

INDUSTRY INSIGHTS CONTINUED

Developing Scalable, Global Solutions For Cell & Gene Manufacturing

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

Balancing Early-Stage Needs With Future Success

Streamlining the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success.

Pioneering Affordable CAR-T Cell Therapies In India

CAR-T cell therapy is poised to transform cancer care in India, with new initiatives aiming to make this breakthrough treatment both clinically feasible and financially accessible.

Maximize Output From Full-Time Employees

Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.

How To Choose The Right CDMO

Advanced therapy manufacturing requires deep biological expertise. Choosing a partner with translational experience and a robust CMC strategy is vital to navigating complex regulatory reviews.

Bridging Studies For Producer Cell Line Adoption

Delve into how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.

Bispecific T- Cell Engager (BiTE) Screening, Automated Pipeline

View automated, high‑throughput BiTE screening in mammalian cells, enabling rapid discovery of efficacious variants through precise genomic integration and scalable workflows.

Vendor To Visionary: Transforming AAV Manufacturing

Early, collaborative CDMO partnerships optimize AAV development, enhancing manufacturability and reducing risks to shorten timelines more effectively than traditional transactional models.

Synthetic DNA As An Alternative For Scalable Viral Vector Production

Enzymatically synthesized DNA is assessed as a plasmid alternative, showing comparable viral vector yield, quality, and purification, while improving scalability and regulatory flexibility.

A Faster Path To Genomic Medicine Feasibility

Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.

SPONSOR

Outsourced Pharma Capabilities Update July 2026: Gene Therapy (July 28, 11am ET)

As gene therapy programs advance toward scalable, regulated manufacturing, early decisions carry greater risk and complexity. This session explores how leading CDMOs support end to end development, from process design to GMP production and commercialization. Experts will discuss strategies that reduce downstream risks, improve scalability, and streamline tech transfer, offering practical insight into how CDMO choices impact success across the product lifecycle. Learn more.

SOLUTIONS

Efficient, Single-Source PFS Supply

Accelerate Drug Development With Innovative 360˚ CDMO And CRO Solutions

Expanding To Develop And Deliver Tomorrow's Cures

Simplify Your mRNA Workflow From The Start

Cell Therapy Lot Release Package

Speed, Precision, Impact: The CRO Revolutionizing Bioanalysis

3D Modeling Of Facilities With Digital Twin Technology

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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