Life Science Rabbit Hole #17: Autologous Cell Therapy Facility Design

Readers of the Life Science Rabbit Hole may recall Life Science Rabbit Hole #11: “Making It”, which explored how the supply side of the Cell and Gene Therapy (CGT) industry might evolve as these products become better understood, as increased scale is required to support wider use, and as the broader healthcare ecosystem responds to the pricing challenge posed by these therapies.

The article suggested what technical, commercial, and political considerations could lead life science companies to outsource and/or locate their CGT production to either

1. Large-scale outsourced production based in high-price, early adopter markets such as the US and Europe
2. Large-scale outsourced production based in low-cost regions such as India
3. Small-scale, localized, near-to-patient production

The factors highlighted in “Making It” certainly apply to autologous cell therapies, where 1 lot = 1 patient.?

That being said, the design, construction and operational qualification of autologous CGT production facilities definitely have unique requirements.

Our partners at Orchestra Life Sciences have just published Designing Facilities for the Future of Autologous Cell Therapy: Top 5 Considerations, presenting key facility design considerations for autologous cell therapy products.?

The article makes recommendations for the following 5 areas:

1. Operational Modeling
2. Cross-Contamination Prevention
3. Redundancies
4. Electronic Batch Records (EBR)
5. Automation

Please take a look. The Orchestra Life Sciences team has deep and practical experience in cutting-edge life science technologies.

Concluding Thoughts

If you are a reader of the Life Science Rabbit Hole, you are probably a participant in the broader life science ecosystem.?

You probably realize what a privileged position you have, being able to accelerate the development of therapies, medical products & services that improve and extend the lives of patients and those who love them.

I hope you find this edition of the Life Science Rabbit Hole useful to you as you lead your organization and our industry.

As always, your comments and suggestions are welcome.