Draft:Bramble Bio


Bramble Bio is a contract development and manufacturing organisation (CDMO) specializing in cell therapy and gene therapy products. It provides end-to-end services for advanced therapy medicinal products (ATMPs) and advanced therapeutic investigational medicinal products (ATIMPs), including process development, optimization, technology transfer, current Good Manufacturing Practice (cGMP) manufacturing, analytical testing, cell and tissue sourcing, regulatory guidance, and global logistics.

History

The organisation originated as FamiCord Cell & Gene Manufacturing, part of the FamiCord Group, a European stem cell banking and biotechnology network founded in 2002. The Warsaw-based CDMO expanded services in the 2010s to include GMP-compliant manufacturing of cell therapies for clinical use. In January 2025, FamiCord Cell & Gene Manufacturing rebranded as Bramble Bio to reflect a broadened mission in advancing cell and gene therapy innovation and to emphasize its interconnected global network of facilities and partners.

Operations

Bramble Bio operates facilities in Warsaw, Poland, and Cantanhede, Portugal, with a network of laboratories and cryopreservation sites across Europe, the Middle East, and Asia. It has supported the development, manufacture, and distribution of ATMPs for clinical trials in a broad range of indications, contributing to therapies administered to thousands of patients worldwide.

Services

The company’s core activities include:

Partnerships

Bramble Bio collaborates with biotech companies and research organisations to manufacture and scale advanced therapies, exemplified by strategic partnerships for production of treatments for diseases such as Duchenne muscular dystrophy and acute kidney injury.

Headquarters

The company’s headquarters is located in Warsaw, Poland, with an additional operational facility in Cantanhede, Portugal.

References

https://www.ema.europa.eu/en/news/new-guidelines-good-manufacturing-practices-advanced-therapies

https://eur-lex.europa.eu/eli/reg/2007/1394/oj/eng

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice

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