Progenitor Cell Therapy's management team, extensive manufacturing and regulatory experience, and facilities have made it the industry's partner of choice for the development and manufacture of cell therapies.Focus and Commitment to Cell Therapies
Whether you are in the early stages of product development, in clinical trials, or moving to commercialization, PCT can provide you with the consultative or manufacturing partnership you need to get your product to market.
PCT is a client-based cell therapy services company that supports the development of cellular therapies by providing cGMP-compliant cell manufacturing and consulting services that address regulatory, financial, technical, process and quality systems needs.
The PCT advantage includes:
PCT works with its clients at the bench or in the market to advance cell therapy products and the companies behind them.
PCT’s management team has incomparable experience with cell-based therapeutics including 14,000+ cell therapy procedures, 10,000+ cellular products manufactured, and participation in more than 50 clinical trials in the US and Europe.
Sate-of-the-art cG(x)P Facilities
Fully licensed contract manufacturing facilities located on the East (Hackensack, NJ) and West (Mountain View, CA) coasts of the USA. Manufacturing is performed in ISO Class 7/Class 10,000 or ISO Class 8/ Class 100,000 clean rooms. Both facilities have onsite QA, fully equipped QC laboratories, controlled materials warehousing and fully equipped R&D laboratories.
PCT has years of experience in, and numerous successful examples of, working with US and international regulatory authorities.
It is critical to PCT’s business that we maintain an air and ground transportation network that provides 24/7 processing and delivery options.
Extensive Industry Network
No company has a broader base of internal and external content experts in the cell therapy sector than PCT. PCT’s clients, consultants, strategic partners, collaborators, and independent contracts represent the industry’s leaders in cell-based product development, research, and patient care.
PCT’s cGMP nationwide network of laboratories enables it to provide a full spectrum of support services, including:
process development and/or validation,
product characterization and/or development,
product comparability studies,
technology and/or licensing evaluation assessments,
financial modeling for product development and commercialization,
strategic development and/or project management
quality plan/protocols/systems audits,
product manufacturing for clinical trials,
commercial-scale product manufacturing,
Master File development,
Biological License Applications (BLA),
preparation for and/or representation at regulatory meetings,
regulatory submissions, amendments, supplements, and reports,
cell and tissue collection, processing, and/or storage
diagnostics/biologic product testing, and
product distribution and/or transportation.
Last updated: 06-09-2006
Progenitor Cell Therapy