Newsletter | September 22, 2025

09.22.25 -- How AbbVie's Digital Transformation Brought Platform Knowledge Closer

SPONSOR

Check out this poster which details where alternative technologies can replace traditional testing strategies, the additional viral clearance studies some vector products are expected to complete, and how these changes will influence the viral safety testing strategies for future CGT products. Learn more

FOCUS ON OUTSOURCING

How AbbVie's Digital Transformation Brought Platform Knowledge Closer

A custom-built digital ecosystem reduced the time spent on documentation in AbbVie's bioprocess development labs by about 70% for some experiment types.

Allogeneic Vs. Autologous Cell Therapy: Deciding On Your Product Strategy

As you develop your future cell therapy drug, consider the risks and benefits of using autologous or allogeneic methods to best suit your development and manufacturing needs.

How To Build Effective Clinical Trial Oversight And Leadership

In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

Electroporation, LNPs For Targeted CRISPR/Cas9 Gene Editing In T-Cells

This study compared non-viral transfection methods in primary human T-cells, demonstrating the feasibility of an LNP-based process encapsulating CRISPR/Cas9 and HDR template DNA in a single payload.

A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

Solving Bispecific Antibody Heavy-Light Chain Mispairing

Discover a bispecific pairing technology that drives correct heavy-light chain pairing rates in IgG-like bispecifics to >95%. This improves yields of the correct species and streamlines downstream processing.

The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells

Founder and CEO Ruby Tsai, Ph.D., delves into the general methodologies for reducing immunogenicity in cell-based therapeutics and highlights the unique approach employed to overcome immune rejection challenges.

Conduct Early-Phase Studies To Improve Manufacturability, Mitigate Risk

While clinical efficacy is the critical benchmark for any drug program, ensuring manufacturability is also vital. An experienced CDMO can help you establish efficient and cost-effective production strategies.

Leveraging HTS Tech To Develop Methods For rAAV Characterization

Consider an advanced sequencing protocols and bioinformatics solutions to achieve comprehensive rAAV characterization, ensuring precise analysis of purity, integrity, and identity.

Balancing Early-Stage Needs With Future Success

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.

OUTSOURCING SOLUTIONS

Particles In High Concentration Biotherapeutics - Pace® Life Sciences

Services For Advancing mRNA-LNPs From Bench To Clinic - Cytiva

A Concept-To-Commercial Gene Therapy CDMO - Andelyn Biosciences

A CDMO Partner From CMC Development To Commercial Supply - Kincell Bio

Powering Progress With High-Performance Lentiviral Vectors - Vector BioMed

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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