Newsletter | December 9, 2025

12.09.25 -- 2025 Tariffs Barely Impact Europe's API Supply Chains

INDUSTRY INSIGHTS

How To Solve The Big Challenges Of Cell And Gene Therapy Manufacturing

Cell and gene therapies are revolutionizing medicine, but outdated manufacturing methods are slowing progress. Discover how modernizing CGT production can unlock a treatment's full potential.

mRNA Therapeutic Development Through Enhanced IVT Capping Efficiency

See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.

Crafting Scalable Solutions For Maximum Reach And Success

Is your supply chain ready for a blockbuster cell and gene therapy launch? Industry leaders discuss selecting partners, managing risk, and scaling operations for maximum reach and success.

FEATURED EDITORIAL

2025 Tariffs Barely Impact Europe's API Supply Chains

When earlier this year the Trump administration began waving the specter of tariffs on drug substances and products entering the U.S., the biopharma world held its breath. European countries, as much as even China, felt the lack of oxygen. Would, for example, global sponsors leave European CDMOs to relocate their API production at contractors in the U.S.? Here's what we uncovered.

Solving The Stem Cell Consistency Conundrum With iMSCs

The ability to produce unlimited batches of induced mesenchymal stem cells from a single iPSC cell bank is, perhaps, one of their most alluring features.

INDUSTRY INSIGHTS CONTINUED

Streamlining Analytical Release Testing With Faster, Smaller Workflows

Reducing turnaround times and sample volumes in release testing can accelerate cell therapy manufacturing, preserve product yield, and improve patient outcomes.

How Strategic CMC Planning Drives Cell Therapy Success

Here, we identify twelve critical CMC challenges that frequently threaten cell therapy development programs and provide practical strategies to overcome them.

The High Requirements Placed On Pharmaceutical Labeling Solutions

Regulators are implementing new rules to combat counterfeit medicines. Learn how serialization, tamper-evident seals, and track-and-trace solutions protect products and patients from risk.

Recommendations For Successful IND Approval Of RNA-LNP Drugs

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

Exploring An Integrated Solution For AAV Vector Clinical Production

Every choice is critical in AAV vector production. Experts share how to make the right choices, from the process and cell line, to off-the-shelf plasmids and qualified analytical methods.

Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing

When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

Transferring Potency Assays From Lab To GMP Production: Strategies For Success

With experience in managing assay transfers across diverse sources and development stages, we have identified five factors that can significantly impact the success of potency assay transfers.

Demonstrating Value Throughout The Product Development Lifecycle

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

Building Excellence In Pharma Manufacturing Through Rigor

A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. See how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.

Making A Meaningful Impact In AAV

At this year’s Meeting on the Mesa, Viralgen's Chief Commercial Officer Andy Holt shared updates on three strategic initiatives designed to streamline gene therapy development.

SOLUTIONS

Allogeneic CAR-T Cells

By combining scientific expertise with deep functional characterization, our annotation platform helps inform manufacturing decisions and guide donor selection for allogeneic CAR-T development.

Master And Working Cell Banks, 24/7 Monitoring

Our master and working cell banks are customized to meet your specific requirements for size, concentration, and in-process and release testing.

Translating Groundbreaking Research Into Life-Changing Therapies

Our flexible partnership models empower you to scale efficiently and confidently — whether advancing a single molecule or managing a complex portfolio of therapeutic candidates.

The Future Of Lentiviral Vector Innovation And Access

Witness how the VBM and the LENTIVERSE™ technology platform provide a full suite of tools capable of quickly delivering state-of-the-art therapies and developing next-generation products.

Cell Therapy CDMO Services Tailored To Your Needs

Leveraging the technology, expertise, and capacity of a cell therapy CDMO is crucial to reduce timelines and lower costs as you bring your novel cell therapy from discovery to commercialization.

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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