Enabling translational research from bench to bedside with a single cell line
Ensure MCB compatibility with your differentiation process: By testing a vial of material matched to the MCB, you can be assured the clinical grade material will be suitable for generating your clinical trial product.
Accelerate your timelines: MCBs were produced under cGMP conditions and have been fully tested for viruses and adventitious agents per FDA guidelines. The ability to begin with production of a Working Cell Bank rather than a MCB production saves at least 6–12 months.
Eliminate cross-over studies for multiple MCBs or multiple cell lines: The number of MCB vials to be purchased is based on your needs. Depending on the clinical application and the ultimate success of clinical studies, the number of MCB vials acquired can meet your pre-clinical, clinical, and initial commercial needs.
Secure support for regulatory submissions: Donor consent, cell line provenance, Waisman Biomanufacturing Facility Master File, and consultation with Waisman Biomanufacturing and WiCell personnel to answer other regulatory questions is included for use in IND applications.
Protect your research investment and mitigate your risks: Move from research to clinical trials seamlessly by utilizing Clinical Grade (cGMP) MCBs with Matched Research Banks.
Available now: WA01 (H1), WA09 (H9), and WA14 (H14) Master Cell Bank Material
cGMP stem cell banks are the foundation of the future in translational research
Proven expertise through a powerful partnership
Waisman Biomanufacturing (WB) has in-depth experience manufacturing cell and gene therapeutics for human Phase I/II clinical trials. WB has developed platform manufacturing processes and analytical methods to support clinical production of MSCs, hESCs, and iPSCs. Key components offered for cellular therapies include reprogramming vectors, cGMP cell banks, and final cell therapeutics including differentiated cell types. WB provides full support for IND filings by providing QA-audited batch records, CMC support and access to the Waisman Biomanufacturing Facility Master File. Learn more at http://www.gmpbio.org/.