Newsletter | November 25, 2025

11.25.25 -- The 15% Tariff: A Modest Jolt Or Deeper Disruption?

SPONSOR

All key players - CMOs, CDMOs, pharmaceutical companies, service and equipment vendors, government and institutions - convened in one place to participate at the Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) 2026 on 20-21 April. This event is set to shape the future of the industry. Located in Amsterdam, the Congress leverages its position in the heart of the pharmaceutical cluster.

INDUSTRY INSIGHTS

Know Your Product, Know Your Path: A Primer On Advanced Therapy Development

To prevent path-to-market setbacks, it is critical to develop a Chemistry, Manufacturing, and Controls strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls

Ensure a smooth and efficient technology transfer by following key strategies and avoiding common pitfalls to streamline your process and achieve consistent, error-free results.

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.

FEATURED EDITORIAL

The 15% Tariff: A Modest Jolt Or Deeper Disruption?

Regarding the U.S. / EU “agreement” to a blanket 15% tariff on pharmaceuticals entering the former from the latter, I zero in on the potential effects of outsourcing active pharmaceutical ingredients (APIs). A 2025 analysis indicates 43% of branded pharmaceutical APIs used in U.S. prescriptions come from the EU. Learn more about our predicament from a case study and a closer look.

Analyzing CAR-T Surface Proteins With IP-MS

Among other benefits, immunoprecipitation coupled with mass spectrometry (IP-MS) can help compare CAR constructs, evaluate manufacturing processes, and monitor changes in protein interactions.

INDUSTRY INSIGHTS CONTINUED

Linking Clinical Correlates To Cell Therapy Outcomes

Streamline cell therapy development by transforming complex cellular characteristics into a predictive, multiparametric metric that guides the selection of high-potential starting material.

Developing A Gene Therapy In 14 Months: Science, Partnership, And Capabilities

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.

Monoclonals: Revolutionizing Pathogen Treatments

Infectious disease mAb therapies are entering clinical trials at a record pace. Review the trends driving the use of mAb treatments as well as key considerations to remain competitive in the race to market.

DoE Approach Suggests Transfection Viable-Cell Density As Key Parameter

Uncover how a model was developed to address the multifactorial nature of large-scale transfection, where variables like viable cell density (VCD) and DNA amount jointly influence efficiency.

Outsourcing RNA-LNP Production: A Key To Competitive Success

Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.

Reinventing Viral Vector Manufacturing For A Decentralized Therapy Future

In this interview, Mike Kadan, Ph.D., MBA, Chief Operating Officer of Vector BioMed, shares how the company is reimagining viral vector manufacturing through a purpose-built, modular platform.

Engineering Rep-Cap Plasmids To Enhance AAV Manufacturability, Potency

Here, we explain how our engineered Rep-Cap plasmids dramatically enhance AAV vector yield, quality, and scalability, offering a powerful, next-generation solution to overcome manufacturing challenges.

Balancing Early-Stage Needs With Future Success To Advance Tech Transfer

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.

From Platform To Patient: Streamlining Gene Therapy Development

Consider the advantages of platform processes for advancing novel gene therapies, the role of robust partnerships, and how these collaborative efforts are shaping the future of therapeutic development.

Overcoming Obstacles In Gene Therapy Manufacturing

The unique challenges of a viral vector asset or molecule require high-throughput processes and analytical development solutions, coupled with extensive industry experience.

Comparing Synthesis Processes To Establish rAAV Batch Quality

In this study, we present a comprehensive analysis of various published and newly developed dsDNA conversion processes that were tested using the same sequencing chemistry.

Streamline Biopharmaceutical Manufacturing With Versatile Platforms

Gain insights into how standardized quality controls, robust analytics, and streamlined processes can improve efficiency, reliability, and scalability across the development lifecycle.

SOLUTIONS

LEG14-Mediated TCR Knock-In For T-Cell Engineering

LEG14 nuclease and mbDNA templates enable efficient, non-viral TCR knock-in in T-cells, doubling NYESO-1 targeting efficiency compared to plasmid-based approaches.

Fill/Finish Capabilities Update January 2025

From early development to full-scale global commercialization, our proven track record with international regulatory agencies underscores our ability to navigate complex requirements.

Capabilities Update April 2025: CGT

Follow along as we recall our experience in providing clinical CAR-T products to the clinic for more than five years and our plans to deliver a pivotal drug product for patients.

Cell Line Engineering Services

Whether you need precise single-base edits, large safe-harbor insertions, or other knock-in/knock-out changes, our exclusive technologies and expert scientists deliver exceptional results.

Our Team Of Experts Are With You Every Step Of The Way

We simply need your gene of interest (GOI) to provide swift, top-notch cGMP material using our optimized one-stream platform to help reduce cost and expedite the journey to clinical trials.

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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