Clinical Grade Tissue Products

Clinical Grade Products

GMP-COMPLIANT ALLOGENEIC CLINICAL GRADE PROVIDER

AllCells’ Clinical Grade product line is for further manufacturing of allogeneic cell-based therapies.

We partner with you to determine exactly what is needed for success. With experience in drug development, third party and commercial manufacturing, and regulatory aspects of licensed products, our staff will help you identify program needs and recommend all cell material from discovery to clinical trial licensure to commercial production. Clinical Grade product offerings are intended for use as starting materials for your cell therapies and consist of Fresh Whole Bone Marrow and Fresh Leukopak.

GMP-compliant Clinical Grade Products


FRESH WHOLE BONE MARROW

AllCells’ Clinical Grade Fresh Whole Bone Marrow is a rich source of adult stem cells such as CD34+ hematopoietic stem and progenitor cells. These cells are capable of differentiating into all of the mature blood cell types. Mesenchymal stromal/stem cells are also found in bone marrow and have been shown to have therapeutic potential in several cardiovascular, autoimmune, and immune-based diseases.

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FRESH LEUKOPAK

AllCells’ Clinical Grade Fresh Leukopak products are the perfect starting material for allogeneic applications. They contain a high concentration of all major lymphocyte populations, T Cells, B Cells, NK Cells, and monocytes. AllCells maintains on-site collection of all its products, which provides customers with a streamlined process for procuring and ordering clinical grade primary cells.

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Extensive Research Donor Pool

Donor Screening and Tissue Collection


Donors from our research donor pool are further qualified for donation of clinical grade products through extensive FDA-specified viral screening by CLIA-approved laboratories, AABB-derived health history verifications, and physical assessments completed by our medical team.

  • We value our donors’ privacy and follow strict HIPAA guidelines to safeguard their personal information. In addition, we obtain donor consent through processes outlined by the NIH and approved by an independent IRB.
  • AllCells’ IRB-approved screening protocols are adaptable to your scientific requirements.
  • AllCells rigorous screening limits the risk of donor failures and the potential expense of not being able to utilize your internal or outsourced production capacity.

Clinical Grade Tissues

Superior Quality

AllCells aids customers in navigating the complexities of shipping Clinical Grade tissues by providing assurances based on our knowledge of operational requirements and critical chain logistics.
AllCells’ comprehensive operational facility SOPs, QMS, QAAs, documented training, GMP collection documentation, localized chain of custody from donor to shipment, validated release assays, compendial testing, rigorous QA review, and demonstrated stability provide the assurances needed.

  • At AllCells, we test the sterility of Bone Marrow and Leukopak Clinical Grade products through compendial testing by qualified laboratories.
  • At AllCells, our validated, small format recyclable packaging eliminates risk of transient temperature excursions during shipment from our California laboratory to your facility or CMO, worldwide.

Download Our Brochure


Our Clinical Grade brochure is now available for immediate download. Learn more about our GMP-compliant Clinical Grade products.

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AllCells Clinical Grade Brochure

Regulatory Oversight


Comprehensive understanding of both domestic and EU regulations for the collection of tissues and cells for human application. Donors are screened and tissues are collected in accordance with GMP, CFR 21 Part 1271 and EU directives 2004/23/EC and 2006/17/EC.

Need More Information?


We realize the importance of finding the right partner for your research and want to make it as easy as possible for you to find the answers to all of your questions. Please contact our experienced Clinical Grade Team via our easy email form below.

Have a question? Let’s chat.