Fresh GMP Leukopaks

Fresh GMP Leukopaks

CGT Global Clinical Leukopaks are GMP-compliant and intended for use in Cell Therapy manufacturing processes.  Clinical Leukopaks are and collected from IRB-approved consented healthy donors at 6 coast-to-coast FDA registered collection centers by qualified and trained staff using the Terumo Spectra Optia cMNC collection protocol.  Donor eligibility is determined following the AABB approved Donor History Questionnaire for Hematopoietic Progenitor Cells (HPC-DHQ) and in compliance with FDA 21 CFR Part 1271 subpart C for infectious disease testing and physical examination. CGT Global laboratories are FDA and CLIA registered and standard infectious disease testing is performed by a qualified provider using FDA-licensed test methods.

 

The CGT Global Difference 

CGT Global is a Biospecimen Provider for a wide range of clinical and preclinical research projects. Our state-of-the-art laboratories and collection centers are located nationwide and provide end-to-end services: These services include:   

  • Process, isolate, and cryopreserve cells immediately after donor collection 
  • Amazing customer service and fast shipping
  • Customize products to distinct study specifications 
  • Retain specific donor demographics and a safe, highly recallable donor pool 
  • HLA Typed Primary Cells
  • Biobanked cells
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Description

Full GMP Leukopak collections target a minimum 10 Billion TNC yield and ≥ 90% viability and are shipped fresh for same day, overnight or international delivery and documentation provided is customizable and compliant with GMP. CGT Global Quality reviews each batch for accuracy and release.

 

For more information or a custom project evaluation, request more information.

 

Additional information

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