Newsletter | March 24, 2026

03.24.26 -- The Long Road To U.S. Vaccine Manufacturing

INDUSTRY INSIGHTS

Adapting An Adherent hCK Cell Line To A Serum-Free Suspension RCB

Learn about the development of a serum-free suspension MDCK cell line that serves as an optimal platform for isolating human influenza viruses from clinical samples and producing vaccines at scale.

Using Plant Peptones To Boost Plasmid Yield And Induction

Uncover how our plant-based peptones support E. coli growth, plasmid yield, and controlled induction, offering a sustainable, animal-free alternative for biopharmaceutical cell culture.

The Crucial Role Of Apheresis In Cellular Therapies

Focusing on quality, the presenters will discuss the importance of adhering to collection protocols and the real-world effects on treatment outcomes.

FEATURED EDITORIAL

The Long Road To U.S. Vaccine Manufacturing

GeoVax CEO David Dodd sings the praises and is grateful for the program-enabling relationships he has in Europe. At the same time, he harbors lingering disappointment. From the outset of its formation, the biotech has desired to work with U.S.-based CDMOs. He will not give up. “One way or the other,” Dodd says, “GeoVax will have U.S.-based manufacturing.”

Trends In FDA FY 2025 Warning Letters

The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

INDUSTRY INSIGHTS CONTINUED

Efficient Plasmid Linearization: Type I & II Enzymes

Advanced plasmid linearization improves transfection efficiency and gene expression, delivering high-purity DNA with rapid turnaround, low endotoxin, and scalable processes for CGT applications.

The Evolving Landscape Of Fill/Finish: Trends, Challenges, What's Ahead

Discover how surging demand for GLP-1 and other therapeutics is transforming fill/finish capacity and regulatory standards. Learn how CDMOs are adapting to the complex needs of emerging modalities.

A Comprehensive Solution For Adventitious Agent Testing

Modern sequencing methods offer detection of adventitious and species‑specific viruses. Assimilate how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

Gene Therapy Delivered In 14 Months

Hear how one family, driven by urgency, partnered with AAV experts to develop a treatment for their daughter’s ultra-rare neurodegenerative disorder, NEDAMSS, in just 14 months.

Phase-Appropriate Approaches To Manufacturing And Testing

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

Choosing The Best mRNA Manufacturing Strategy

Choosing the right mRNA manufacturing model can define your success. Uncover how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.

Smarter Pathways To Scale In Cell And Gene Therapy Manufacturing

As the field evolves, the strategies developers choose may prove just as influential as the therapies themselves in determining how quickly innovation reaches patients.

SOLUTIONS

Cell Therapy Lot Release Package

Comprehensive cGMP-compliant cell therapy lot release testing includes identity, potency, safety, and characterization assays, ensuring regulatory compliance and timely product release.

Unlocking Healthier Futures With Cell And Gene Therapy

Leveraging a partner with expertise and integrated, end-to-end solutions can help overcome obstacles to increase patient access and ensure the safe distribution of your advanced therapy product.

Advancing Vaccines From Preclinical Development To Commercial Supply

We are an established leader in advancing vaccines from preclinical development to commercial supply across multiple modalities.

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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