Human Raw Materials in Cell Therapy Manufacturing

Human raw materials play a central role in the development and manufacturing of cell and gene therapies (CGT) as they directly impact process robustness, cell performance, and regulatory readiness. Commonly used materials include leukopaks, human sera, and plasma‑derived protein such as human serum albumin, all of which require strict donor characterization, traceability, and reliable supply. 


Variability in donor material, insufficient characterization, or incomplete documentation can introduce manufacturing risk, affect reproducibility, and complicate regulatory interactions throughout clinical development and commercialization. 

Why Quality Matters

Choosing well-characterized, high-quality human materials is fundamental to building reliable and scalable cell therapy processes. High material quality supports:

  • Enhanced T-cell and CAR-T growth and viability
  • Reduced process variability and improved batch-to-batch consistency
  • A smoother transition from clinical development to commercial manufacturing
  • Lower overall manufacturing and clinical risk

By minimizing variability at the material level, developers can increase confidence in both clinical outcomes and long-term process performance.

Key Material Requirements in CT Manufacturing

To support robust, scalable, and compliant cell therapy manufacturing, human-derived materials should meet the following requirements:

Reliable plasma sourcing and supply continuity

Access to well‑characterized starting materials, supported by a stable and diverse donor base, ensures consistent availability from early development through commercialization.

Consistent, fit‑for‑purpose quality

Clearly defined specifications and quality controls help reduce variability and support reproducible performance across batches.

Flexible formats to match workflows

Availability of materials in formats such as fresh or cryopreserved enables use across different stages, from feasibility studies to commercial manufacturing.

Availability across product types and grades

Materials offered as RUO and GMP, and in multiple formats (e.g., bags, vials), support a smooth transition from research to clinical manufacturing.

Traceability and complete documentation

Full donor traceability, testing data, and supporting documentation facilitate quality assessment and regulatory review.

Alignment with regulatory expectations

Materials produced under appropriate quality systems, supported by the necessary documentation, help enable approvals and commercialization.

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A step by step overview of the role of human raw materials in cell therapy manufacturing process

Regulatory Considerations for Human Biological Materials in CGT

A deep understanding of the regulatory landscape of raw materials is essential for the development and manufacturing of cell therapies. Regulatory expectations vary depending on how materials are classified and used within the manufacturing process, making early material selection and qualification critical.

Starting Material

These are biological materials used at the beginning of the manufacturing process to create cell-based medicinal products.


Examples:
Leukopaks
High‑risk, human‑derived starting materials that require stringent, risk‑based controls, including donor screening, quality testing, full traceability, supplier qualification, and strict batch consistency, due to their direct impact on product safety, quality, and consistency.

Raw/Ancillary Material (AMs)

These materials are used during manufacturing and may contact cells or tissues, but are not intended to be present in the final product.
They must be qualified for identity, purity, and suitability. Risk classification, quality oversight, and documentation determine their acceptability within a given process.
 

Examples:
Human Serum Albumin
Generally considered a very low‑risk1 ancillary material when sourced from a licensed medicinal product. Highly purified and well‑characterized, and widely used across both autologous and allogeneic cell therapy workflows.
Human Male AB Serum
Classified as a low‑risk1 ancillary material when sourced from controlled and well‑characterized donors and produced under an established quality system. 

Excipients

These substances are included in the final formulation alongside the active pharmaceutical ingredient (API).
 

Examples:
Human Serum Albumin
Highly purified, well-characterized, and widely used to support stability in cell therapy.

Enabling Regulatory Readiness and Manufacturing Scalability

The use of consistent, traceable, and well‑documented human biological materials is a key enabler of regulatory readiness in cell therapy manufacturing. Working with materials that align with regulatory expectations can help streamline interactions with health authorities, reduce development risk, and support the successful advancement of innovative cell therapy programs from early development to commercialization.
Recognizing how these materials impact performance and risk helps teams design more predictable and efficient cell therapy workflows.

Meet Our Cell Therapy Solutions to Support Therapy Success

Leukopaks

  • Dual sourcing from US and EU centers
  • High mononuclear cell yield
  • Proven safety 
  • Viral testing according to FDA or EMA regulations for all donors
  • Leukopak donors are qualified individuals with prior plasma donation experience, adding an extra layer of safety
  • Backup donor scheduling to ensure on-time availability and delivery
  • Research and GMP grades available


Formats available

  • Fresh
  • Split
  • Cryopreserved


Documentation provided

  • Certificate of analysis (CoA)
  • Donor demographics
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Human Serum Albumin

  • Manufactured from plasma sourced from our US-based FDA- and EMA-approved plasmapheresis centers
  • Our production strictly adheres to cGMP, ICH, and Plasma Protein Therapeutic Association standards
  • Therapeutic grade quality: Licensed medical product (USP and EP)2 
  • High purity: ≥96%


Formats available (100 mL)

  • Bottles: 20% and 25% HSA solution
  • Bags: 25% HSA solution


Documentation provided

  • Certificate of analysis (CoA)
  • BSE/TSE statement
  • Processing overview document
  • Supporting documentation and dossiers to support IND/MA processes

 

 

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Male AB Serum

  • Collected in FDA and/or EMA-approved centers
  • Manufactured in ISO-certified, cGMP-compliant facilities
  • Proven safety 
  • Gamma-irradiated and heat-inactivated by default
  • Tested for viral markers, mycoplasma, endotoxins, and more
  • Available in large lot sizes for better reproducibility


Formats available

  • 100 mL bottles
  • 500 mL bottles


Documentation provided

  • Certificate of origin (CoO)
  • Certificate of analysis (CoA)
  • Viral inactivation study*
  • Safety data sheet
  • Processing overview document*

 

*Provided under the appropriate agreement

 

 

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Raw materials for cell therapy manufacture

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References

  1. USP 1043. Ancillary materials for cell, gene, and tissue-engineered products. Rockville, MD: United States Pharmacopeia; 2022.
  2. Tanaka T, Okada K, Yamamoto Y, et al. Comparison of guidelines for biological ancillary materials used for the manufacture of gene and cellular therapy products in Asia. Cytotherapy. 2023;25(2):220-228.

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