Tailored
Support

Partnering for Cell
Therapy Success

At Comprehensive Cell Solutions (CCS), we recognize that every cell therapy program is unique. Whether you’re in early research or advancing toward late-stage clinical trials, our team provides customized, end-to-end support to help you navigate development, manufacturing, and regulatory hurdles — accelerating your path to the clinic.

Consulting

Navigating the complexities of cell therapy development requires expert guidance. CCS offers strategic consulting services to help biotech and pharmaceutical companies optimize workflows, address regulatory challenges, and accelerate time to market.

Regulatory & Compliance Guidance

We provide expert insights into FDA and ICH regulations, ensuring your cell therapy program meets compliance standards.

Process Optimization & Scale-Up

Our team supports process design, scale-up strategies, and technology transfer to ensure efficiency and reproducibility.

CMC & Quality Consulting

We help optimize Chemistry, Manufacturing, and Controls (CMC) strategies, focusing on quality, risk mitigation, and regulatory readiness.

Preclinical & Clinical Development Strategy

From early research to clinical trial design, we provide strategic input to de-risk development and enhance scalability.

Starting
Materials

Quality Starting Materials for Effective Therapies

Success begins with the right source material. We provide comprehensive support to secure and optimize allogeneic and autologous cell therapy starting materials, including:
  • Donor & Patient Screening: Selection from a diverse, pre-screened donor pool.
  • Customized Collection Protocols: Standardized and scalable cell collection.
  • Starting Material Characterization: Ensuring quality, consistency, and viability.

Optimizing the Cell Therapy Manufacturing Process

Efficiency, reproducibility, and regulatory compliance are critical to cell therapy success. Whether refining an existing process or designing a new one, we help optimize:
  • Process Development: Enhancing efficiency and scalability.
  • Cell Expansion & Cryopreservation: Maintaining quality and viability.
  • Analytical Method Development & Validation: Ensuring product consistency.

GMP Readiness & Technology Transfer

Seamless tech transfer and robust analytical validation are essential for clinical success. Our team has deep expertise in gap analyses, method validations, and tech transfers for both clinical and FDA-regulated products, including:
  • Assay Development & Validation: Meeting regulatory standards.
  • GMP-Compliant Testing: Identity, potency, and purity validation.
  • Technology Transfer Support: For internal teams or external partners.

Manufacturing
Expertise

GMP Manufacturing: From Clinical Trials to Commercialization

We provide phase-appropriate GMP manufacturing for autologous and allogeneic therapies, ensuring clinical readiness and scalability for commercial production. While large-scale commercial capacity is planned for Biogenesis Park on Long Island, we have successfully manufactured Phase I/II clinical trial products at our New York and Louisville facilities.
  • Scalable GMP Manufacturing: Supporting Phase I-II clinical trials.
  • Seamless Scale-Up Strategies: Preparing for commercial production.
  • Regulatory Support: Ensuring successful IND/BLA submissions.
  • Tech Transfer & Optimization: Ensuring smooth transitions from R&D to GMP.

CCS Biomanufacturing: Innovation, Quality & Compliance

  • Decades of Expertise: Supporting cell therapy innovation from concept to clinic.
  • Flexible & Scalable Solutions: Tailored support to fit your specific needs.
  • Regulatory & Compliance Focus: Ensuring smooth FDA interactions and GMP compliance.
  • Seamless Team Integration: Acting as an extension of your in-house capabilities.

Development & Manufacturing

  • Decades of experience in apheresis, cell sourcing, and regulatory-compliant infrastructure.
  • Seamless integration from collection to manufacturing, reducing time-to-treatment.
  • Extensive donor network and the largest cryopreserved cord blood supply in the U.S.
  • Proven expertise in supporting cutting-edge cell and gene therapy programs from early research to clinical trials. 

Project
Management

Navigating the complexities of cell therapy development requires expert guidance. CCS offers strategic consulting services to help biotech and pharmaceutical companies optimize workflows, address regulatory challenges, and accelerate time to market.

Tailored Cell & Gene Therapies Project Planning

We develop customized roadmaps from preclinical research to clinical manufacturing, ensuring milestone-driven progress in advanced therapies development. 

Dedicated Single Point of Contact

Our experienced project managers align stakeholders, regulatory teams, and manufacturing partners for seamless execution.

Regulatory Compliance & Quality Oversight

CCS ensures full regulatory compliance with FDA standards, supporting clinical trial management without compromising quality and innovation.

Proactive Risk Management & Resource Optimization

We identify and mitigate risks early, ensuring efficient resource allocation and cost-effective execution.

Real-Time Tracking & Communication

We provide routine updates, dashboards, and real-time monitoring, ensuring full visibility into project status and regulatory timelines.

Multi-Site GMP Project Coordination

CCS facilitates GMP project coordination in advanced therapies, integrating cell sourcing, process development, and cryopreservation for seamless execution. 

Cellular
Therapies

At CCS, our tailored approach doesn’t stop at development and manufacturing — we also provide deep expertise across diverse cell therapy modalities. Whether you’re working with autologous or allogeneic therapies, our solutions are designed to meet the specific needs of your therapy and patient population.

Autologous Cell Therapy

We understand the complexity and personalization of autologous cell therapies requiring precise production workflow due to its time-sensitiveness. We are committed to effectively plan production, release and shipment of these autologous products ensuring patients receive quality products on time every time. We provide our clients with comprehensive scale out planning based on demand ensuring capacity meets customer needs. Our Draw-to-Thaw™ facilities in New York and Louisville, KY, as well as longstanding relationships with partner hospitals and proven logistics services, enables direct integration of autologous apheresis collections into manufacturing, reducing the time to patient treatment and optimizing supply chain efficiency.

Allogeneic Cell Therapy

With expertise in sourcing cells from cord blood, as well as non-mobilized apheresis from healthy donors, CCS utilizes the latest technology to scale up and support the development of off-the-shelf donor-derived allogeneic therapies. We provide best in class quality control measures ensuring product meets desires critical parameters and quality attributes along with generating enough doses for clients to conduct their clinical trials.

Cell Therapy Modalities We Support

CCS provides expertise in collecting and processing cells for the following cell therapy types:

  • Chimeric Antigen Receptor (CAR)-T and (CAR)-NK Cell Therapy
  • TCR-T Cell Therapy
  • T-Reg Therapy
  • Tumor-Infiltrating Lymphocyte (TIL) Therapy
  • Gamma Delta (γδ) T Cells
  • Natural Killer (NK) Cell Therapy
  • Mesenchymal Stem Cells
  • Dendritic Cell Therapy
  • Stem Cell Therapy

Accelerate Your Path to the Clinic

Whether you’re in early development or preparing for pivotal trials, Comprehensive Cell Solutions is here to help. Contact us today to discuss how we can tailor our expertise to your program’s needs and bring your therapy to patients faster.