08.07.25 -- Exploring Outsourcing's Role In CGT Scalability And Affordability

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

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

With extensive experience in managing assay transfers across diverse sources and development stages, we have identified five critical factors that can significantly impact the success of potency assay transfers.

Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.

Create a simple, modular path to cGMP manufacturing that minimizes risk. Explore a strategic approach for early-stage development and how it can propel therapies to the clinic and the market.

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.

Listen as Mike Dybicz shares how HV3 and Safepak innovations are transforming CGT logistics to ensure the safe and reliable delivery of life-saving therapies.