Newsletter | June 2, 2026

06.02.26 -- Can A Biotech Create A CDMO Market?

SPONSOR

Join editor Jeff Buguliskis on June 4, 2026, at 11 a.m. ET for Outsourced Pharma Live: Beyond Data Packages: Derisking Tech Transfer To CDMOs. Industry experts will explore how sponsors can better prepare for successful tech transfers by addressing common challenges including incomplete data packages, equipment differences, method variability, global standards, and CMC alignment. Learn strategies using smarter documentation, DOE, and in silico modeling to improve right-first-time transfer success. Register now

INDUSTRY INSIGHTS

Unlocking Durable Allogeneic Cell Therapy

Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.

The Switch To Cell-Free DNA: Streamlining Advanced Therapy Manufacturing

Cell‑free DNA manufacturing removes bacterial risk and complexity, enabling faster, flexible production that supports advanced and personalized therapies with consistent quality and regulatory confidence.

Delivering Therapies Without Delay Using An Integrated Platform

Eliminating discontinuity between R&D and cGMP manufacturing, through mirrored environments, accelerates the journey to IND and patient access and bypasses delays in clinical transfer.

FEATURED EDITORIAL

Can A Biotech Create A CDMO Market?

Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

Advising The Biotech C-Suite To Reconsider Quality

“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

Applying Contamination Control By Design: A Practical Guide For CDMOs

This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

INDUSTRY INSIGHTS CONTINUED

PAT Monitoring And Control Roadmap

Implement PAT effectively with a roadmap that covers techniques, validation, data integrity, and lifecycle strategies to help teams improve quality, control, and productivity.

The Continuation Of A Journey

See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

Plasmid DNA For Cell & Gene Therapy: It All Starts Here

Explore how tailored manufacturing solutions can enhance program outcomes, leverage cutting-edge technologies for research and discovery, and optimize preclinical applications.

Next-Gen HEK Cell Lines For Viral Vector Production

Assimilate how cutting-edge advancements in viral vector production and innovative cell line development are overcoming the challenges of scaling gene and cell therapies.

Designing Cell Therapy Analytical Programs For Regulatory Success

Expedited cell therapy pathways demand early, reliable analytical development to ensure robust data, regulatory confidence, and smooth transitions from discovery through clinical stages.

How To Effectively Manage Local Affiliate Pharmacovigilance Outsourcing

Managing PV across dozens of markets strains even experienced safety teams. Learn about a framework that helps you maintain compliance, reduce risk, and scale confidently into new markets.

Effective Strategies To Minimize Product Loss During Fill Finish

Every drop of high-value biologic lost in fill finish is money left on the table. Read practical, process-driven strategies to protect your yield and maximize efficiency.

SPONSOR

Outsourced Pharma Capabilities Update - Cell Therapy

Join us on June 16th for a virtual event on cell therapy manufacturing and CDMO selection. Experts will discuss how early development decisions affect scalability, GMP manufacturing, tech transfer, supply chains, and commercial readiness. The session explores strategies to reduce downstream risks like inconsistent quality and operational delays. Intended for CMC, manufacturing, quality, regulatory, supply chain, and procurement professionals evaluating cell therapy outsourcing partners. Click here to learn more.

SOLUTIONS

Viral Vector CDMO Services

Your All-In AAV, All-The-Time CDMO

Comprehensive, Integrated BioServices

Automated, Single-Use System For Clinical And Commercial LNP Production

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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