Newsletter | February 10, 2026

02.10.26 -- Trump's Big Pharma Deals Drive CDMO Investments

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AI Innovation in Drug Development

AI is shifting from experimentation to execution in drug development. This OPCU special edition explores where AI delivers value today—across discovery, CMC, and quality—and how CDMOs and sponsors can collaborate to reduce risk, improve quality, and accelerate timelines, with practical guidance on readiness, regulatory considerations, and sponsor expectations.

INDUSTRY INSIGHTS

What Is ISO 21973 And Why It Matters For Cell And Gene Therapy

ISO 21973 establishes global best practices for transporting cell and gene therapies, ensuring quality, safety, and consistency across complex supply chains critical to patient outcomes.

Silencing Lentiviral Cargo For Cell Therapy

Silencing lentiviral cargo genes boosts vector yield, enhances cell viability, and reduces impurities, enabling scalable, cost-effective manufacturing for complex gene therapies.

Integrating Analytical Method Development And Quality Control

As cell and gene therapies continue to advance, a well-integrated analytical framework will be critical for accelerating development timelines and optimizing regulatory submissions.

FEATURED EDITORIAL

Trump's Big Pharma Deals Drive CDMO Investments

It is a remarkable twist of industry manipulations, government suasion, and economics. J&J cut a Most Favored Nation deal with the Trump administration that includes lowering prices – via TrumpRx.com – building more in the U.S., and (here’s the twist) investing in the U.S.-based facilities of a Japanese-owned CDMO. Got all that? Chief Editor Louis Garguilo offers analysis.

In Vivo's Biggest Threat — Comparison To Old Models

In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

INDUSTRY INSIGHTS CONTINUED

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.

Collaborate With A Partner To Bring Your Rare Disease Therapy To Clinic

Choosing the CDMO best suited to manufacture your rare disease therapy can be challenging. Ideally, a CDMO will prioritize your goals while working to ensure quality and regulatory success.

Solving The Sequencing Puzzle: Speed, Cost, And Quality

Next-generation sequencing (NGS) accelerates therapy development by enabling rapid, cost-effective DNA/RNA analysis crucial for cell and gene therapies, process optimization, and impurity detection.

Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

CM Partnering For Adaptable, Accelerated Market Acceptance

The need for manufacturing support that offers adaptable, scalable solutions has become more crucial than ever for the diagnostic space.

Enabling CTA Submission In Record Time: Adenovirus Program Success

What does it take to bring an adenovirus-based therapy to the clinic – faster and without compromising quality? Find actionable insights to help improve efficiency and accelerate development timelines.

SOLUTIONS

The Future Of Lentiviral Vector Innovation And Access

Built on deep expertise in viral vector design and manufacturing, explore a comprehensive set of tools to rapidly deliver advanced therapies and support the development of next-generation treatments.

iPSC Generation Services

iPSC generation is a complex process of reprogramming adult somatic cells into a pluripotent, embryonic stem cell-like stage.

CHO Edge System

Achieve high monoclonal antibody and complex bispecific titers routinely with an IND-approved cell line development platform that integrates genetic tools and data-driven models.

Two-Side Labeler For Challenging Product Shapes

This two-sided labeling machine brings precision and versatility to your production line. This high-speed workhorse labels up to 200 products per minute, even those with challenging shapes.

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: