MEDIPOST Calls On Charles River Laboratories To Help Scale GMP-Compliant Stem Cell Therapy
As MEDIPOST ventures abroad, Charles River will provide GMP-compliant biologics and cell therapy testing services to help advance the pipeline into new markets.
Key Points
- Charles River Laboratories and MEDIPOST have signed a non-exclusive MOU focused on GMP-compliant biologics and cell therapy testing.
- Charles River will support MEDIPOST’s pipeline with quality control, viral testing, release testing, and related services across APAC and North America.
MEDIPOST, a Korean biotech company, manufactures an umbilical cord-derived mesenchymal stem cell therapy called Cartistem, which has been approved in Korea for over a decade for knee osteoarthritis. If you haven’t read into Cartistem, it’s a fascinating therapy, showing true potential for cartilage regeneration. I’ve written about them several times over the years and think they have the potential to change the landscape of orthobiologics. The therapy has been used in over 36,000 patients to date in South Korea alone.
They’re currently venturing overseas. Just a few weeks ago, they announced the completion of their Phase 3 in Japan, which showed good symptom relief and cartilage regeneration, and they’re beginning their Phase 3 in the USA sometime this year. They have teased that it may possibly expand in the Middle East and Europe as well.
However, entering new countries presents novel regulatory challenges, as each government has unique CMC requirements, some of which are still being hashed out by regulatory bodies for the cell therapies.
To help, they announced they’re calling on Charles River Laboratories to support GMP-compliant biologics testing and commercialization. For those unaware, Charles River is a Massachusetts-based contract research organization specializing in drug and biologics development and scale-up.
Testing and Commercialization Support
Charles River offers a variety of services for cell & gene therapies, including:
- Cell Banking
- Cell Line Characterization
- Viral Clearance Studies
- Bulk Harvest Testing
- Assay Development
- Contamination/Impurity Testing
- Product Characterization
- Stability Testing
- And more
They also mention on their website that they’ve helped develop 10+ FDA-approved cell & gene therapies, and have conducted over 1000 cell & gene therapy studies as of 2021. They’re doing a webinar on Tuesday, May 19th, about securing consistent, reliable starting material for cell therapy development. You can register for that here.
It will be interesting to see how the first scale-up abroad goes for MEDIPOST. They’ve just shown they can replicate the trial results in another country, which is a big deal. The next question is: can they mass-manufacture the therapy to the same standards while meeting local CMC regulations and maintaining a cost-per-dose that makes sense?
MEDIPOST’s CEO, Antonio Lee, Ph.D., did a presentation at the Cell & Gene Meeting on the Mesa, seen here; it’s a great watch:
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