Newsletter | May 26, 2026

05.26.26 -- Why A Cell Therapy CEO Waited Until Phase III To Outsource

SPONSOR

The 6th mRNA Based Therapeutics Summit returns to Boston as the leading forum accelerating mRNA discoveries into scalable, clinically validated therapies. Amid rapid deal making and progress across in vivo CAR T, gene editing, and cancer immunotherapy, 300+ leaders from pharma, biotech, and regulators unite. With three scientific tracks plus new AI driven design and next gen delivery focus days, this flagship event drives innovation, partnerships, and pipeline acceleration. Learn more.

INDUSTRY INSIGHTS

Balancing Speed And Regulation In Cell Therapy

Rapid cell therapy development demands early planning for scalability, standardized platforms, and inspection‑ready operations to meet regulatory expectations and avoid rework in later clinical phases.

Characterization Of Cellular Starting Material

Watch to gain valuable insights into the characterization of cellular source material for the development and manufacture of cell and gene therapy-based products.

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.

FEATURED EDITORIAL

Why A Cell Therapy CEO Waited Until Phase III To Outsource

Sometimes, you have to go it alone. For a while, at least. The mantra across biotech has long been clear: engage your CDMO early, and let those experts guide you into manufacturing. Matthieu de Kalbermatten, CEO of CellProthera, a regenerative cell-therapy developer, begs to differ.

Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem

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.

Forget Tech Transfer. You Need A Cognitive Connection

Cognitive transfer is a concept widely studied in psychology. Today it has growing relevance within our industry’s ever-increasing technology transfers, which have been understood in the main as moving development/manufacturing processes/technologies from one stage, one location, or one organization – as when utilizing CDMOs – to another. Time now to zero in on the communicating of tacit or implicit knowledge, i.e., knowledge or experience difficult to extract through data or written explanation. This is where cognitive transfer enters our portal. Here's an analysis.

INDUSTRY INSIGHTS CONTINUED

Redefining Biomanufacturing For Personalized Cancer Vaccines

Personalized cancer vaccines need fast, flexible manufacturing. Cell‑free synthetic DNA enables rapid, small‑batch mRNA production, supporting individualized therapies beyond plasmid‑based limits.

Myths That Make Early CDMO Engagement Look Like A Risk

Early CDMO engagement isn’t premature—it prevents CMC-driven delays, reduces comparability risk, and aligns AAV manufacturing decisions with long-term clinical and commercial success.

Collaborative Variability Reduction In Cell Culture Media

Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

Boosting Plasmid Yield & Integrity With PowerS-ITR

Our platform boosts plasmid DNA yield, preserves ITR integrity, and reduces variability, enabling scalable, cost-effective manufacturing for gene therapy and vaccine applications.

Set Your Cell And Gene Therapy Program Up For Success From Day One

Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

From Gene Therapy To Patients: Cost‑Effective AAV Production

Understanding how upstream control, downstream efficiency, and process robustness scale together is essential for protecting supply and expanding patient access.

Lipid Nanoparticles Boost CRISPR HDR Gene Insertion in Human T Cells

Lipid nanoparticles enable precise, non-viral gene editing in T cells to achieve high HDR efficiency and viability in scalable workflows. Explore how this approach overcomes viral vector limitations.

Risk To Readiness: Smart CMC Strategy Defines Advanced Therapy Success

Early, phase-appropriate CMC planning is critical for advanced therapy success. Proactively managing regulatory risks and applying Quality by Design principles secures a clear path to market.

CDMO Trends Impacting 2025-2026

Economic pressures, funding shifts, and evolving therapeutic pipelines are reshaping CDMO capacity in 2025, with 2026 expected to bring intensified competition and strategic realignments.

Transitioning From Using RUO To cGMP Chemicals For Clinical Trials

Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.

SOLUTIONS

Advancing Innovation In Cell And Gene Therapy Manufacturing

Give Your Gene Therapy The Kickstart It Deserves

iPSC Generation Services

Delivering End-To-End Cell And Gene Therapy Expertise

Viral Vector Development And Manufacturing Services

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.

Connect With Outsourced Pharma: