Newsletter | December 15, 2025

12.15.25 -- Strained Manufacturing, Complexity Stymie In Vivo Progress

SPONSOR

The 2026 ISPE Facilities of the Future Conference will provide actionable insights and real-world case study examples addressing key industry challenges and opportunities, from best practices in facility design, digital transformation, and emerging technologies, to sustainability initiatives, workforce development, and compliance-related considerations. Gather innovative ideas on how to align your business priorities with forward-looking trends and prepare for the future. Learn more

FOCUS ON OUTSOURCING

Strained Manufacturing, Complexity Stymie In Vivo Progress

 Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational 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.

Laminar And Turbulent Mixing Techniques For LNP Formulations

Explore the critical factors in scaling up lipid nanoparticle (LNP) formulation, comparing the advantages and limitations of both laminar (microfluidic) and turbulent (tee and jet) mixing technologies.

Delivering Therapies Without Delay Using An Integrated Platform

Eliminating discontinuity between R&D and cGMP manufacturing, through mirrored environments, accelerates the journey to IND and patient access and bypasses delays in clinical transfer.

Working With An End-To-End CDMO To De-Risk AAV Production

Consider how the following strategies can be used to optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

Optimal Tech For Predicting Drug Responses At The Cellular Level

Assimilate how preserving spatial molecular information and leveraging AI-driven spatial-omics can transform treatment prediction, patient stratification, and personalized medicine.

Advanced Therapy Tech: 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.

Addressing Complex Challenges And Developing Innovative Solutions

Uncover two projects that focus on improving efficiency and productivity in biopharmaceutical manufacturing while reducing the cost of goods through process intensification.

Making A Meaningful Impact In AAV

Viralgen’s Andy Holt at Meeting on the Mesa 2025 highlighted in-house plasmid manufacturing, expanded commercialization development, and cost reduction in gene therapy manufacturing.

Partner Case Study: Accelerating Gene Editing Manufacturing

Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.

Accelerate Your Bispecific Antibody Development

Jin Lu, Ph.D., Senior Technical Support Manager, shares how novel expression tools can advance your early-stage bispecific antibody discovery programs toward clinical success.

OUTSOURCING SOLUTIONS

Alcami Capacity Update: Fill/Finish - Alcami

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

Proven Expertise And Customized End-To-End Solutions For Your Products - IDT Biologika

A Platform For Lentivirus-Based Cell And Gene Therapy Manufacturing - MilliporeSigma

Testing Solutions For RNA-Based Products - SGS

Roadmap To Successful Drug Therapy Partnerships - Eurofins

Connect With Cell & Gene: