Newsletter | January 12, 2026

01.12.26 -- Driving Efficiency, Reducing Costs In Multi-Modal CGT Manufacturing

FOCUS ON OUTSOURCING

Driving Efficiency, Reducing Costs In Multi-Modal CGT Manufacturing

As CGT pipelines diversify, many biotechs are outsourcing production of multiple modalities to the same manufacturing partner. Understanding how those partners manage risk, optimize facility space, and control costs is critical to protecting CGT companies’ products and patients.

Navigating CMC Regulation For Plasmid DNA In Gene Therapy

Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

Optimizing AAV8 Capsid Purification With Oversized GOI

Enhance AAV gene therapy quality and regulatory compliance with our advanced AEX-based purification platform, achieving >90% full capsid purity — even for oversized AAV8 vectors.

How To Design And Evaluate Bispecific Antibodies (BsAbs)?

Bispecific antibodies combine two antigen-binding sites to enhance efficacy and safety. Their design requires structural strategy, MOA-based evaluation, and rigorous screening for optimal therapeutic performance.

Science, Partnership, And Capability: Developing A Gene Therapy 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.

Streamlining AAV And LVV Manufacturing Platform Solutions

Observe how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.

Defining Specificity Within The ELISpot Assay

Achieving high-quality T cell ELISpot results requires robust controls to verify antigen-specific activation. Learn the experiments and best practices for establishing and confirming assay specificity.

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.

Versatile Manufacturing Platform For CGT And Oncolytic Virus Production

Discover how the iCELLis500+ fixed-bed bioreactor supports the scalable manufacturing of both AAV and oncolytic virus therapies, detailing successful process development and scale-up strategies.

Single-Use Innovation For The Future Of Therapeutic Manufacturing

Gain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.

Engineered Plasmids And Optimized HEK293 Cell Line Improves AAV Productivity

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

Accelerated LVV Manufacturing Enabled By Platform Excellence

Overcome viral vector supply gaps by leveraging a scalable platform. Read how an accelerated eight-month manufacturing timeline supports clinical milestones without compromising yield or quality.

OUTSOURCING SOLUTIONS

Immunotherapy Development - Excellos

Bridging The Gaps: Enhancing First And Last Mile Resilience - Cryoport Systems

See How We Bring Biotech Innovation To Life! - 3PBIOVIAN

Manufacturing GTP And GMP - Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

Give Your Gene Therapy The Kickstart It Deserves - Viralgen

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