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美國Progenitor Cell Therapy (PCT)
Progenitor Cell Therapy (PCT) 是一家以客戶為中心的服務企業(yè)，為細胞療法的開發(fā)與推廣提供支持。PCT 提供符合 cGMP 標準的細胞生產與咨詢服務，滿足監(jiān)管、金融、技術、工藝和質量體系戰(zhàn)略。該公司提供與工藝和產品開發(fā)、驗證、盡職調查、評估、組織采集、處理以及存儲、產品生產、分銷與運輸相關的全方位支持與咨詢服務。

 The Partner of Choice for the Development and Manufacturing of Cell Therapies

Progenitor Cell Therapy (PCT) is a client-based cell therapy services company that supports the development and commercialization of cellular therapies. PCT provides cGMP-compliant cell manufacturing and consulting services that address regulatory, financial, technical, process, and quality system strategies. Services include a full spectrum of support and consulting related to process and product development, validation, due diligence evaluations, tissue collection, processing, and storage, product manufacturing, distribution and transportation.

Click here for a PDF copy of the PCT brochure

Click here to view PCT's online presentation

Click here for a PDF copy of PCT's corporate overview presentation

Our Commitment
We have a long term commitment to the development of effective cell therapies as the emerging paradigm for the treatment of disease. Our unique and wide-ranging experience spans the entire spectrum of cell therapy product development from research to processing and manufacturing, and from regulatory and quality compliance to clinical application.

Our team of professionals is prepared to offer their expertise to support your product development needs, from pre-clinical and clinical research and development, to regulation, accreditation, reimbursement and the commercialization for cellular therapies.

Our Service Product
To date, Progenitor Cell Therapy has processed more than 3,000 cellular products for over 1,000 patients and provided cost-effective cell therapy manufacturing services from our cGMP clean room facilities in Hackensack, New Jersey and Mountain View, California.

Our two facilities consist of clean rooms, cryopreserved cellular inventory, and a Quality Control/Testing laboratory capable of performing flow cytometry, thermal cycling (PCR), ELISA, microbiology and cellular morphology analysis.

Our facilities, processes, and personnel are in compliance with the cGMP and cGTP regulations, the standards of the FDA, FACT, AABB, and are accredited by the following organizations for various purposes:

The Foundation for the Accreditation of Cell Therapy (FACT)
The College of American Pathologists (CAP)
AABB
Progenitor Cell Therapy provides door-to-door cell transportation services within the continental United States for environment-sensitive and time-critical packages. We have partnered with a specialized package delivery airline and network of ground couriers.

For those looking to engage in clinical trials, Progenitor Cell Therapy also has access to a large patient population base and a wide range of clinical protocols in cell therapy. These clinical protocols include Investigator New Drug (IND) and Investigational Device Evaluation (IDE) developed with and by Progenitor Cell Therapy for the clinical evaluation of its client's products.

Progenitor Cell Therapy has developed mechanisms, processes, and expertise to confer the highest likelihood of success for development of cell-based products at any stage in the developmental pathway.