Newsletter | March 10, 2026

03.10.26 -- The Supreme Court Rules On Trump Tariffs. Why Shout "Hooray!"?

SPONSOR

Join our experienced panelists as they break down how to transform your CDMO partnerships from sources of stress into strategic assets. Register for free thanks to support from Simtra. More info here!

INDUSTRY INSIGHTS

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Compressing Tech Transfer Timelines Through Digital CMC Standardization

Digital CMC platforms address tech transfer inefficiencies by unifying process knowledge, reducing compliance risk, and significantly compressing CDMO onboarding timelines.

Balancing Speed And Regulation In Cell Therapy

Rapid cell therapy development demands early planning for scalability, standardized platforms, and inspection‑ready operations to meet regulatory expectations and avoid costly rework in clinical phases.

FEATURED EDITORIAL

The Supreme Court Rules On Trump Tariffs. Why Shout "Hooray!"?

Chief Editor Louis Garguilo says like many readers, he agrees with the "wise and narrow decision" by the U.S. Supreme Court that President Trump cannot use the International Emergency Economic Powers Act to impose sweeping tariffs. At the same time, for those who immediately threw up an instant “Hooray!” he suggests checking yourself on why such enthusiasm. His analysis on what is actually best for our global outsourcing industry.

The Real Reason We Haven't Fully Automated Cell Therapy Yet

Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

INDUSTRY INSIGHTS CONTINUED

Driving Compliance And Standardization In CGT Supply Chains

Standardization and compliance in CGT supply chains are critical for minimizing risk, ensuring product integrity, and meeting regulatory demands across global manufacturing and distribution networks.

Reducing Costs To Improve Patient Access

To ensure the commercial success of cell therapies, developers must adopt innovative manufacturing and QC technologies that reduce COGS while enhancing scalability, quality, and clinical outcomes.

Developing Scalable, Global Solutions For Cell & Gene Manufacturing

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

Accelerating The Development And Manufacturing Of CGT

Learn how the following rapid development framework can accelerate your viral vector, CAR-T, and iPSC programs, reduce risk, and streamline your path from development to commercial manufacturing.

The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells

Explore how gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

Growing A Sustainability Culture Across An Expanding CDMO Network

Peter Skals, Head of Global Sustainability, shares how the company is integrating its climate and ESG strategy while simultaneously expanding its CDMO network and reducing its CO2 footprint.

Novel Engineered Plasmids And Optimized Cell Line Improves Productivity

Low AAV productivity and lack of platform processes continue to be challenges, driving AAV production cost up. Uncover a robust and scalable suspension manufacturing platform for AAV production.

SOLUTIONS

Industrial Fermentation

Animal‑free, high‑quality peptones, hydrolysates, and yeast extracts for industrial fermentation, delivering scalable, soluble, reliable media without supply delays.

A Concept-To-Commercial Gene Therapy CDMO

This adherent platform has been used to manufacture more than 450 Phase 1 and 2 clinical batches, spanning over 17 years and covering a variety of serotypes and indications.

Streamlining CRISPR-Cas9 Gene Editing

This technology enables CRISPR delivery for TCR knockout in T cells, improving viability and expansion over electroporation, with optimized RNA ratios and liposome volumes driving editing success.

Powering Gene Therapy Progress

A streamlined model delivers high-quality, cost-efficient lentiviral vectors, accelerating gene therapy programs from early research through clinical development.

A Faster, More Reliable Path To Viral Vector Manufacturing

Accelerate your journey from R&D to cGMP-grade LVV production with POSTmark, reaching scalable, high-quality outcomes in just 6–9 months with greater efficiency and reduced risk.

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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