Cell Therapy cGMP Production
Our cGMP cleanrooms are designed with flexibility in mind.
Capable of supporting open, manual manipulation or fully closed, automated technologies, our cleanrooms are EMA and FDA compliant.
Where We Can Help
The production of your cell therapy program starts with having the correct raw materials, tested to the appropriate standards and ready to use. Our systems are built to enable right-sized quality standards for your product’s clinical phase; this includes production batch records which can be paper-based while your program is evolving, and then proceed to our electronic batch record system.
Our tenured cGMP manufacturing, quality and support teams are passionate about delivering therapies for patients. In-process, as well as final product testing capabilities, are in-house to ensure robust results are available.
Our cGMP Capabilities
Material qualification, sourcing and procurement, and supplier qualification are adapted to every clinical (or commercial) phase requirements.
Our cell therapy facility has been using electronic record keeping in production since 2018. For earlier phase programs, paper batch record options are available to ensure quick adaptation of process modifications are possible.
The Grade B cleanrooms at our cell therapy facility are platform agnostic, enabling flexibility to support open, manual manipulation processes or closed and automated technologies that can provide your program added levels of control:
- Our dedicated teams are experienced and vigilant when it comes to your program’s sterility assurance, capable of leveraging Grade A BSCs, aseptic qualification and ongoing operator coaching, as well as a robust environmental monitoring program. Our cleanrooms have enabled open manipulation of suspension and adherent cell populations since GMP operations began in 2018.
- Technology advancements and automation have made it a very exciting time to be in the cell therapy industry. The design of our cleanrooms allows for adaptability to many new platforms. We can accommodate your strategy and equipment choice, whether you are slowly introducing automation and closure at your most vulnerable steps, or converting your entire process to a closed platform.
The manufacturing, quality and support teams at FDB receive robust platform-based training and qualifications, and they receive enhanced training for each new product/process to ensure the team supporting your program is fully equipped to deliver the highest quality product.
cGMP QC laboratories are accessible directly across the hall from our cGMP cleanrooms. This ensures timely handoff of samples requiring in-process analysis and quick data reporting to keep your process on track and on time.
Learn more about our
Customer Success
Fast-Tracking Development of MSC-Based Cell and Extracellular Vesicle Therapies Through a Strategic Partnership
