Why Are Apheresis Collections Important?
There has been significant growth in the number of clinical trials for cellular and gene therapies (CGT), with the FDA announcing in January 2019 that it had 800 CGT investigational new drug (IND) applications on file and expects to receive 200 new applications annually beginning in 2020. By 2025, the FDA anticipates approving 10 to 20 new cell and gene therapy products each year, meaning that relatively large numbers of these therapies may reach the commercial market within the next five years.
Cellular collections by apheresis is a critical first step in the development of these cellular therapy products. The challenge of collecting cellular therapy products in greater volume while maintaining product integrity highlights the need for high quality, reliable apheresis services.
What Components of Apheresis Collections by Comprehensive Cell Solutions Offer?
New York Blood Center’s Comprehensive Cell Solutions (CCS) apheresis collections can provide a variety of cellular components, including:
Unstimulated or Stimulated apheresis collections using G-CSF and/or plerixafor:
o Mononuclear cells (lymphocytes and monocytes)
o Hematopoietic stem cells
These cellular products may be used for training, bench research, and/or clinical trials.
Why Partner with Comprehensive Cell Solutions for Apheresis Collections?
CCS’s resources, expertise, high customer satisfaction, and history as a blood center ensure quality systems which address safety, quality, identity, potency and purity and has made CCS an industry leader in apheresis and cellular therapy. NYBCe’s Comprehensive Cell Solutions has been nationally recognized by organizations such as NMDP as a leader in cellular therapy collections. Our expertise in apheresis collections service offers the following benefits:
Available at CCS locations throughout the United States, or at the client’s site
Equipped for both autologous and allogeneic collections
Donor recruitment pool throughout the country
Leukopaks, mononuclear cells (MNCs) or hematopoietic stem cells (HPC) from stimulated donors are collected under IRB-approved protocol
Donors are pre-screened for per FACT requirements for medical history and infectious disease markers
Products can have cell counts provided
Expert nursing and medical staff
Use of FDA-approved equipment at all CCS locations
Human leukocyte antigen (HLA) testing available
Ability to perform cell processing, cryopreservation and storage
Resulting cellular product can be stored and/or shipped as needed, fresh or frozen
Interested in Apheresis Collections? Contact us below and a team member will follow-up promptly.