Cell Sourcing
& Apheresis

Optimized Process Development
for Cell & Gene Therapies

Service
Description

With roots in a non-profit community blood center Enterprise, CCS has a long-standing reputation for excellence in delivering blood products and services. From supporting the world’s first unrelated donor cord blood transplant to preparing countless bone marrow products and collecting materials for today’s cell therapies, our patient- and donor-focused team is committed to quality and optimal outcomes.

Why
Choose us?

Proud Partner of NMDPsm


Initiating collections for the NMDP (formerly known as the National Marrow Donor Program) in 2005, Comprehensive Cell Solutions has been a preferred partner and NMDP Collection Center since 2022. Since beginning NMDP collection services at CCS, our nurses have collected over 1,700 stem cell and mononuclear cell (i.e., T cell) apheresis products for NMDP transplant patients in the US and internationally.

Commitment to Quality

All products are collected according to NMDP and CCS rigorous quality standards, with the CCS team achieving 98.47% product quality as defined by percentage of collected stem cell products (minimum of CD34+ 4.5×10^6/kg) through final product counts.

Patient & Donor Focus

The CCS apheresis team also regularly exceeds donor satisfaction scores, achieving 4.87 on a scale of 1-5, with criteria such as the team’s ability to provide exceptional medical care, exhibit an outstanding bedside manner, discuss and address any concerns, and demonstrate appreciation for the donation.

What Donors Are Saying:

“Willy was my nurse and was so kind and supportive. He explained things well, he was interactive and funny but allowed me to rest and watch TV without interruptions. He was patient and understanding when I needed to use the restroom.”

Method Development

We design and optimize analytical methods to ensure accurate testing of cell identity, potency, purity, and sterility for your therapy.

Stability Studies

We design stability-indicating assays to assess long-term storage and shelf life, ensuring reliable quality control for cell therapy products.

Process Monitoring & In-Process Testing

We conduct in-process testing to ensure process control, consistency, and product quality, using metrics like cell count, viability, phenotype analysis, and advanced proteomic/genomic monitoring.

Release Testing

We develop assays to confirm that your cell therapy product meets all specifications and critical quality attributes for clinical use.

Characterization of Cell-Based Products

We provide flow cytometry, ELISA, PCR, and other assays to verify cell identity, purity, and potency, ensuring regulatory and clinical compliance.

Documentation

We provide comprehensive, traceable documentation to support regulatory filings and ensure a seamless submission process.

You may also be interested in:

Characterizing Starting Materials for Cell and Gene Therapy Development

The Role of Early Characterization Studies in the Assessment of Advanced Therapeutic Potency

Adopting Modular, Semi-Automated Approaches to Optimize Process and Analytical Development for CGT