Discovery Cryo
Leukopaks™ for Clinical Use

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+2,800

highly characterized, 
recallable donors

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>98%

mononuclear cells in every leukopak

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< 48 hours

from collection to delivery

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~95%

pre-freeze viability of Discovery Cryo Leukopaks™ (GMP)

Overview: Experience the confidence of Discovery Leukopaks™

Accelerate Your Allogeneic Cell Therapy Programs with Discovery

Beyond a focus on quality, which is a given for any material being used in clinical development, GMP compliant Discovery Leukopaks offer a number of unique advantages that can help save your allogeneic cell therapy program time and enrich your insights into product performance.

 

DOCUMENTATION:

RELATED PRODUCTS:

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Key Reasons Why You Should Consider Discovery Cryo Leukopaks

Optimal Scheduling

  • Discovery Cryo Leukopaks allow your scientists to schedule their time, experiments, and downstream processes on their preferred schedule versus a fresh delivery schedule.

Same Quality Product

  • Discovery Cryo Leukopaks have the same cell population mix, viability, and cell counts as Discovery Fresh Leukopaks.

Deep Characterization

  • Know the cell populations, HLA-Type, demographics, and real-time virus data when you select your Discovery Cryo Leukopak.

Risk Mitigation

  • Avoid wasted resources on a planned manufacturing run due to failed donor collection or logistics challenges

DISCOVERY'S ADVANTAGES

Scalability

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With 2,800+ recallable leukapheresis donors, we can support any scale project with high-quality, GMP compliant leukopaks for clinical use.

 

 

Detailed donor characterization

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In addition to the typical donor demographic information and infectious disease testing the FDA requires, we routinely HLA type all donors to 6-digit resolution using NGS.

 

Consistency

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We maintain a single chain of custody – from collection and leukapheresis to characterization and distribution of leukopaks to our clients. This affords consistent, rigorous quality control measures throughout and improves donor recallability via well-established donor relationships.

Compliance

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Discovery Cryo Leukopaks™ (GMP) are FDA registered, CFR 1271, GTP and GMP compliant, ISO 13485 certified.

Advanced Analysis and Cell Processing

The FDA licensed GMP Collection facility is housed in the same building as our Cell Processing, Flow Cytometry and our HudsonAlpha Discovery Sequencing and Bioinformatics, which provides highly sophisticated analyses and high quality data meeting our customers’ turnaround time needs.

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CONSULTATIVE CELL SERVICES

Detailed Information

Discovery Leukopaks are manufactured from the peripheral blood of normal human donors in the GMP compliant collection room at our wholly owned and operated US Donor Center.

EACH DISCOVERY LEUKOPAK CONSISTS OF A CONCENTRATED FRACTION OF MONONUCLEAR CELLS INCLUDING:

  • B cells
  • Dendritic cells
  • T cells
  • Monocytes
  • NK cells
  • CD34+

All cells are obtained using IRB approved consent forms and protocols. Each donor is tested for HIV, HBV, HCV, and CMV, and HLA typed via 6-digit NGS. Additional characterization can be performed—please inquire.

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Discovery Cryo Leukopaks (GMP)Product No.List Price
Full Collection240181.2Contact Us for Pricing

Donor Information

All cells are obtained using IRB approved consent forms and protocols. 
We perform extensive characterization of all donors that includes:

Demographic Information

  • Age
  • Height
  • Sex
  • Smoking status
  • Ethnicity
  • Blood type
  • Weight

HLA-typing to 6-digit resolution with NGS

Virus Testing Every 90 Days and Within 7 Days of Collection

  • Hepatitis B Core Antibody (Anti-HBc EIA)
  • Hepatitis B Surface Antigen (HBsAg EIA)*
  • Hepatitis C Virus Antibody (Anti-HCV EIA)
  • Human Immunodeficiency Virus Antibody (HIV 1/2 plus O)
  • Human T-Lymphotropic Virus Antibody (HTLV-I/II)*
  • HIV-1/HCV/HBV Nucleic Acid Testing*
  • WNV Nucleic Acid Testing*
  • Zika Virus, PCR*
  • Trypanosoma cruzi Antibody*
  • Syphilis antibody*
  • Indirect Agglutination Test*
  • CMV Antibody, IgG
  • CMV Antibody, IgM*
  • SARS-CoV-2, upon demand*
  • Additional tests can be performed— please inquire.

Example of a

Certificate 
of Analysis

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Related Products & Services:

Discovery Life Sciences also offers GMP compliant Discovery Fresh Leukopaks, Discovery Fresh Leukopaks™ (RUO) and cryopreserved, primary immune cell isolates which are produced from Discovery Fresh Leukopaks, with the ability to begin all cell isolation protocols within 1 hour of leukapheresis.

Learn More

Frequently Asked Questions

How long until I receive my first shipment of Discovery Cryo Leukopaks?
Once we receive your purchase order, we can start collections within 2 – 14 days. Depending on your location, we provide same-day or next-day delivery.
Do you have a specific thawing protocol?
Watch a demonstration on our recommended method for handling and thawing.
What cryopreservation protocol do you follow?
We use a controlled rate method that quickly freezes leukopaks after collection to maximize viability, resulting in ~95% viability post-thawing.
Where are your sites?
Our Research Use Only (“RUO”) and our Good Manufacturing Processes (“GMP”) collections are both done in Huntsville, AL, in two separate suites in the same building. Our Cell Biology Lab is also co-located in the same facility, enabling real-time fresh processing or downstream manipulation as needed.
Your samples are all from healthy, normal donors—how do you define “normal"?

For a donor to qualify as normal, they cannot be currently diagnosed or have a history of cancer, autoimmune disease, or any major comorbidity (i.e. diabetes, high blood pressure, etc.). Contact us to learn more.

Can I follow the same donor from RUO to GMP?
Yes. Discovery Life Sciences owns and controls our entire supply chain from donor recruitment, donor screening, donor collection, and logistics to the end user. As a result, our operations are highly efficient and we can ensure a good relationship with our donors, with many returning again and again. Thus, you have the potential to use the same donor from RUO (Research Use Only) collections to GMP compliant collections for clinical use.
Has COVID-19 affected your collection, processing, and/or analytical facilities?
Our collection clinic, cell processing, NGS, and flow cytometry facilities have not been negatively impacted by COVID-19. We are located in Huntsville, Alabama, and have been considered an essential business by the state, enabling our facilities to remain open and fully operational. In addition, we have been able to continuously maintain our supply chain for lab consumables, keeping all projects running on schedule.
What anticoagulant do you use for Discovery Leukopaks™?
We use ACD-A.
What apheresis equipment do you use?
We use Spectra Optia apheresis machines.
Which collection protocol/program and consumable sets are you using?
We use the CMNC (Continuous Mononuclear Cells) Protocol. This allows us to use only one separation process which is far more efficient than the MNC Protocol.
How often can you perform apheresis on a specific donor?
There must be a 61 day delay between one leukopheresis to the next donation. In addition, we require that our donors wait 21 days after a standard venipuncture (whole blood collection) before donating a leukopheresis product.

To propel your projects with The Power of Discovery.™

Contact Us Today

Let us know about your project!

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