Newsletter | July 8, 2024

07.08.24 -- The Path Forward For CLL Is Allogeneic

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The Sponsor's Clinical Development Handbook For Gene Therapy Clinical Trials

Gene therapy has existed for decades, but the field is not as mature as it may seem. Its unique pace, structure, and funding dynamics present distinct challenges. Discover essential insights and strategies for overcoming gene therapy development challenges.

FEATURED EDITORIAL

The Path Forward For CLL Is Allogeneic

Delve into the elements of what make allogeneic CAR T an attractive strategy to target relapsed/refractory Chronic lymphocytic leukemia (CLL) that could also suggest promise in additional scenarios.

Defining The CMC / Clinical Relationship For Allogeneic Cell Therapies

During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.

INDUSTRY INSIGHTS

Choosing A CDMO: Top 10 Intangibles Biotech Firms Should Consider

Selecting a CDMO isn't just entering a transactional relationship. You're forming a long-term partnership that can impact the success of your current products and benefit future product manufacturing.

Flexibility In Gene Therapy: Adapting To The Unique Gene Therapy Demands

Advancements in viral vector design and manufacturing have yielded significant improvements in key areas. This resource helps to keep abreast of innovations in this dynamic and rapidly evolving space.

Promoter And PRE Triage For Gene Expression And Function Optimization

This study demonstrates the effect of different promoters and PREs (Post-Regulatory Element) on multiple CAR and transgenic TCR constructs on titer, integration, expression, and in vitro function.

Put Your AAV On The Fast-Track To The Clinic

Review an innovative approach to fast-tracking AAVs through a platform approach that easily scales as the project progresses to late-stage GMP production and to market.

De-Risk Your Path To Clinic With An AAV Suspension Platform

Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, PhD, Head of Viral Vectors Commercial Development.

Enhancing AAV6 Vector Production For Cell Therapies

For the robust manufacturing of the serotype AAV6, the Pro10™ production platform has proven reliability and scalability, making it suitable for meeting the demands of large-scale manufacturing.

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Addressing the most prominent pain points of speed, cost of production and limited flexibility, the mRNA Process Development & Manufacturing Summit returns to Boston this September. Hear from 30+ technical experts from the likes of Moderna, BioNTech, Sanofi and Strand Therapeutics across three days of content spanning tracks dedicated to Research Scale and IND-Enabling & Clinical Scale production. See agenda

SOLUTIONS

End-To-End Quality Engineering

Cell Therapy CDMO Services Tailored To Your Needs

mRNA-LNP CDMO Services

Benefits Of Standardizing Viral Vector Processes

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