10 Questions to Ask Your Human Biospecimens Provider

Whether your company is a small start-up or a pharmaceutical giant interested in immune and stem cell-based research and therapy development, sourcing consistent and reliable human biospecimens as cellular starting materials is essential for your success.

1. Does the human biospecimens provider (immune and stem cells) have the expertise and resources to meet all the regulatory requirements?

Looking for a provider of human biological samples with an in-depth understanding of regulatory requirements and access to FDA-registered donor centers that meet all CGMP and CGTP standards is a must. Donor centers should have IRB-approved protocols and informed donor consents that adhere to FDA, EMA, PMDA, and other applicable regulatory requirements. 

Additionally, donor centers should maintain compliance with state, federal, and national accreditation standards, including CLIA requirements, to ensure the accuracy and reliability of quality control testing, and AABB standards to verify their quality management systems and controlled collection processes.

2. Does the provider of human biospecimens have experience with the specific cell type being developed? 

Whether a project is being planned for a small academic lab or a large pharmaceutical company, this is one of the first questions to ask. Cells are living organisms with distinct requirements for growth, expansion, and optimal health. They must be maintained in a way that protects their unique function and potential. 

Expertise regarding the specific cell type around which a company builds its pipeline is just as significant. Ideally, a company should look for a provider of human biological specimens that offers an extensive selection of tissues and cell types, since this usually means its scientific staff is skilled at a wide range of cell isolation and handling procedures. 

Suppose immune cells or hematopoietic stem cells are your target. In that case, proven apheresis expertise by the provider of human biological samples is a necessary foundation for delivering high-quality human blood products. Over the past 45+ years, Charles River Cell Solutions (formerly known as HemaCare and Key Biologics) has performed more than 400,000 apheresis procedures in our FDA-registered facility.

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3. What does the donor network look like, and does the human biospecimens provider have access to recallable donors? 

A large, well-characterized donor database is an advantage to any therapy development process. It is one of the most important matters a prospective provider of human biological samples should consider. Regarding donor sourcing, both the quality and consistency of the collected cellular material are crucial. Donors must secure consent in accordance with the Federal Policy for the Protection of Human Subjects using IRB-approved consent forms. Donors must also undergo appropriate serological and infectious disease testing each time a collection is done to ensure the safety of the donor and researchers.

In addition to these basics, a provider of human biological samples, especially of immune and stem cells, should also prioritize building a large network of recallable donors to meet the criteria for any study. Having access to a large pool of recallable donors gives a significant advantage toward ensuring cellular starting material consistency throughout the therapy development continuum — from the discovery phase, to clinical trials, to therapy manufacturing.

As a premium provider of human biological samples, we prioritize building good and lasting relationships with our donors. This increases the probability that a donor will continue to donate regularly and that we will continue to have access to high-value donors.

4. Does the provider have the experience, capacity, and ability to manage donor recruitment processes to meet your specific project needs? 

A large, highly characterized donor pool is crucial, especially when developing specific criteria for an allogeneic cell therapy protocol. The ability to perform enhanced viral screening is also essential to meet international regulatory requirements (e.g., EMA, PMDA). 

The ability to target enough donors of human biospecimens to meet stringent criteria such as gender, blood type, age, BMI limitations, and specific cell compositions is essential. Management of this precious donor pool to ensure compliance with all pre-collection assessments and testing is also vital. A long-standing relationship with donors is vital to ensure they are available for visits to the donation or apheresis center pre- and post-collection.

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5. What sourcing challenges must a provider of human biospecimens overcome to meet your needs?

This is always a good question to ask because it speaks to therapy developers' ability to get what they need for their studies when they need it. For a provider of human biological samples, it's important to know ahead of time how quickly the cellular materials can be sourced, especially if the product will be shipped internationally. 

For example, if basic science researchers or therapy developers have an urgent order for leukopaks or isolated immune or stem cells, a trustworthy apheresis provider should be able to fill the order quickly and efficiently. The apheresis provider should be able to fill special orders from donors screened for particular characteristics and have the flexibility to split orders for shipping to multiple sites. Situations like these come up regularly, and a good human biospecimen provider is always prepared to deal with such challenges, whether the cellular material is fresh or cryopreserved.

6. Which processes does a provider of immune and stem cells follow to ensure consistency and high-quality products?

In the case of human immune and stem cell biospecimens derived from apheresis collections, every donor is different; thus, every apheresis collection starts with some inherent variability. Mitigating risk for a living cellular product means assuring both optimal quality and product consistency. Starting cellular material quality will directly impact downstream therapy efficacy, so the protocols, equipment, and regulatory compliance followed by providers of human biospecimens should focus on maximizing cell viability and functionality. 

In practical terms, this means standardized GMP- and GTP-compliant processes and access to apheresis equipment that minimizes sources of variability. State-of-the-art apheresis equipment, such as Terumo's Spectra Optia® Apheresis System, is an excellent choice, increasing cell collection efficiency and product purity while reducing risk to the donor. 

Setting strong quality control standards, such as guaranteed viability and cell counts, helps ensure that each dose of a cellular therapeutic will have the same potency in every patient. Therapy developers should also receive verified quality control data and comprehensive cellular characterization with each product from their human biospecimen provider.

7. Does the provider of human biological samples supply cryopreserved human biospecimens, including frozen leukopaks and PBMCs, for research and clinical work? 

In the immune cell therapy industry, cryopreservation of leukopaks and PBMCs serves a dual purpose. 

The scientific purpose of the cryopreservation process is to protect and preserve cellular function and to ensure that post-thaw viability and cellular functionality are similar to that of cells in their natural state in the human body. 

The practical purpose, which is intertwined with this, is simplifying logistics—to allow flexibility in the time and place where cellular function will be applied, whether it's five years down the line, halfway across the globe, or both. If a patient is urgently awaiting treatment, it's of great benefit to have the cellular starting material on hand to be processed as quickly as possible. If the therapy developer is planning multiple process development runs on the same day, having the human biospecimens beforehand makes sense. 

Optimally, cryopreserving cellular starting materials for therapy development prevents the loss of viability often seen when fresh products must be transferred between one site and the next or held in storage until processing can take place. Cryopreservation, done right, is the ultimate risk mitigation. Researchers should ensure that prospective providers of human biospecimens, such as apheresis, immune, and stem cells, offer a wide range of both fresh and cryopreserved products. 

In addition to cryopreservation of raw apheresis materials such as leukopaks, it is also important to have the ability to further process and purify various immune cell types (e.g., PBMCs, T-cells, NK cells) directly onsite and same day of the leukopak collection to preserve stability and quality of the isolated immune cells.

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8. Is there collaborative communication with the prospective human biospecimens provider?

Communication is a two-way street. Look for a human biospecimens provider who not only listens to your needs and finds solutions that best fit your project specifications, but also reaches out with newly available resources or innovations that drive efficiency and consistency. 

For example, a good human biospecimens provider should notify you as soon as possible of any changes in timing or availability of cells and tissues of interest. Suppose an apheresis provider partners with another party on a particular project or therapeutic. In that case, both the apheresis provider and the therapy developer should feel comfortable addressing any changes that need to be made or issues that need to be addressed as the project progresses.

9. Can the human biospecimens provider be flexible?

Flexibility is necessary because the ideal human biospecimens and apheresis provider should be able to offer a variety of immune cell types and sourcing options to support researchers and therapy developers as they grow and evolve. Projects may also require different leukopak collection protocols, strategies, and cell isolation methods. 

Customizing cellular collection based on your specific criteria enables you to optimize your research and product development. Working with Charles River Cell Solutions (formerly known as HemaCare and Key Biologics) as your preferred human biospecimen provider gives you access to various protocols and educational materials to help guide your choices. 

For example, we offer different hematopoietic stem cell types that can be requested from multiple tissue sources, customizable cell isolation services, and the ability to request specific donor criteria, including HLA type, blood type, age, gender, and ethnicity. The ability to request repeat collections from high-value recallable donors is also a significant advantage that any prospective therapy developer should use.

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10.  Does the human biospecimens provider have cold chain management processes that follow best practices?

No matter how outstanding the quality of a human biospecimen product may be, it's meaningless unless that quality is safeguarded until it reaches its destination. 

Biological products such as cells and tissues are uniquely temperature-sensitive, so a sophisticated and well-managed cold chain process is critical to protect product integrity. Shipping equipment, including packaging materials and liquid nitrogen dewars, should be optimized and safeguarded with real-time temperature and humidity tracking. Ideally, records of deviations from optimal storage temperature should be automated. 

Cryopreservation (-70°C to -196°C) and biopreservation (2°C – 8°C) methods and materials are just as important. For example, a good immune and stem cell apheresis provider will use standardized, well-controlled protocols that incorporate clinical-grade freezing and storage media certified for full traceability and exact composition. We use BioLife Solutions' CryoStor^® CS10 and HypoThermosol^® because these products have a proven track record in both academic research and clinical trials. The less you need to worry about cold chain logistics-associated risk, the better prepared you will be to commercialize your therapy product.

Why Choose Charles River?

Choosing a human biospecimens vendor is one of the most important decisions a cell therapy company will make. Look for experienced professionals who follow industry best practices, a donor center with a large, recallable, and well-characterized donor database, and a cellular provider that surrounds itself with best-in-class partners. 

With more than 45 years of experience in the apheresis field, we have valuable insights to share that will help you decide which cellular starting material best fits your project needs.