Newsletter | January 6, 2025

01.06.25 -- A Fragmented Outsourcing Landscape: The Difficulties Of Working With Multiple Siloed Partners

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With over 450 unique products in clinical development and 50 anticipated approvals by 2030, the evolving regulatory landscape for cell and gene therapies is more critical than ever. Don't miss your chance to gain expert insights! Join the next Cell & Gene Live for an exclusive digital panel discussion exploring forward-looking perspectives on this transformative field. Registration is free—thanks to the support of Thermo Fisher Scientific.

FOCUS ON OUTSOURCING

Focus On Non-Oncology Indications, In Vivo Gene Editing, And POC

Leaders from Kiji Therapeutics, Precision Biosciences, and Orgenesis weigh in on what will likely accelerate the development of novel treatments, potentially revolutionizing patient care across a wider range of diseases and bringing the promise of personalized medicine closer to reality in 2025 and beyond.

Streamlined Cell Therapy Development: Part II

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

A Fragmented Outsourcing Landscape

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Leveraging Platform Processes For Developing Novel Gene Therapeutics

Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.

Accelerating Your mRNA Drug Development With Analytics

To stay ahead in the competitive landscape of mRNA development, adopt a comprehensive QC strategy today and begin conducting meaningful tests to ensure the quality of your test articles.

Avoiding The Pitfalls Of LNPs And Complex Formulations

Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

Enhancing The Upstream Performance Of AAV Vector Manufacturing

Unlock the potential of AAV manufacturing by leveraging data-driven insights and the advanced Pro10™ platform to optimize processes, enhance productivity, and drive innovation in cell and gene therapy.

3 Fundamental Services For Superior Master Cell Bank Management

The integrity of your master cell bank (MCB) is paramount key in the production of advanced therapies. Selecting a provider with specialized expertise is crucial.

An End-To-End Industrialization Roadmap For Autologous Cell Therapy

Explore specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.

OUTSOURCING SOLUTIONS

Pre-GMP mRNA And LNP Development - Vernal Biosciences

Capacity Update October 2024: Cell & Gene Therapy - FUJIFILM Diosynth Biotechnologies

There's No Substitute For Deep Analytical Experience - Advanced Medicine Partners

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

Workforce Development: Closing The Skill Gap In Cell & Gene Therapy - BioCentriq

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