Apheresis

Comprehensive Apheresis
Solutions for Cell Collections

Service
Description

Variability in donor biology, inconsistencies in cell yield, and stringent regulatory complexities present critical challenges in cell and gene therapy manufacturing, affecting both scalability and clinical efficacy. At CCS, we provide specialized GMP-compliant apheresis procedures that maximize cell viability and deliver high-quality, regulatory-compliant cellular starting materials for cell and gene therapy manufacturing. 

Our expansive apheresis network, spanning hospitals, research institutions, and clinical sites, enables seamless donor access and reliable cell sourcing for advanced therapies. With strategically located collection centers and established hospital partnerships, we ensure consistent, high-yield cell procurement to meet the rigorous demands of manufacturing and clinical applications. 

Our apheresis services ensure the safe and efficient collection of peripheral blood mononuclear cells (PBMCs), hematopoietic progenitor cells (HPCs), and leukapheresis-derived products used in CAR-T therapies, induced pluripotent stem cell (iPSC) research, and advanced therapies applications. 

Effective donor selection is fundamental to ensuring immune compatibility, maintaining consistent cell viability, and manufacturing success. Our donor management services include rigorous donor screening and management, HLA matching, and recallable donor programs, providing biotech and pharma companies with a consistent and high-quality cell supply. 

With decades of experience in apheresis services for clinical applications, CCS provides high-quality GMP-compliant apheresis procedures that support both therapeutic treatments and cell collections for cell and gene therapy (CGT). Our team works alongside clinical staff to ensure patient safety, comfort, and regulatory compliance throughout the process.

CCS specializes in therapeutic apheresis, including plasmapheresis, red cell exchange, and erythrocytapheresis, helping to treat hematologic, autoimmune, and neurological disorders. With expertise in leukapheresis-derived products, stem cell mobilization, and cell sourcing, we deliver optimized apheresis collection protocols to support both patient care and advanced therapies.

Unique
Offerings

Advanced
Therapies

We offer flexible apheresis services, including licensed on-site centers and mobile collection staff, designed to meet the evolving needs of cell and gene therapy development. Our high-quality apheresis collection protocols, regulatory expertise, and advanced logistics ensure a reliable supply of viable, well-characterized cells for clinical and research applications. By integrating efficient workflows, compliance-driven procedures, and scalable solutions, we support the seamless advancement of cell and gene therapy manufacturing. 

Through our extensive hospital and research partnerships, CCS provides unmatched scalability in donor recruitment and apheresis services, enabling both emerging biotech firms and global pharmaceutical companies to access high-quality cellular starting materials with ease.

Our specialized blood management and cell therapy solutions support a wide range of clinical applications, from treating hematologic and autoimmune disorders to enhancing regenerative medicine and surgical recovery. With industry-leading expertise, we ensure safe, effective, and compliant procedures tailored to patient needs. More information on these services can be found on our NYBC Enterprise pages.

High-Precision Apheresis Systems

We utilize automated, closed-system apheresis systems to enhance high-quality cell collection with minimal contamination risk and optimized apheresis collection protocol development.

GTP-Compliant Procedures

Our apheresis program operates under GTP guidelines and adheres to FDA and FACT standards, ensuring compliance for preclinical research, clinical trials, and further cell and gene therapy manufacturing.

Comprehensive Donor Management

We provide end-to-end donor management services, including donor recruitment services, donor eligibility testing, and IRB support and approvals to match specific therapeutic requirements.

Adaptable Apheresis Methods

We offer licensed on-site apheresis suites and mobile collection staff, enabling decentralized donor accessibility, reducing logistical bottlenecks and optimizing supply chain logistics for downstream applications.

Secure Cold Chain Logistics

Collected cells, including GMP cord blood units (CBUs) and research-use-only (RUO) cord blood units, are cryopreserved and transported under validated, controlled conditions to maintain viability and therapeutic potency.

Seamless Integration

As part of our Draw-to-Thaw™ solutions, CCS cryopreserves apheresis collections immediately, ensuring seamless cell and gene therapy manufacturing integration, minimizing delays, reducing cell degradation, and maintaining high post-thaw viability for clinical use.

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