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.
Overview:
Accelerate your allogeneic cell therapy programs with Discovery
Discovery’s Advantages
Scalability
With 2,800+ recallable leukapheresis donors, we can support any scale project with high-quality, GMP compliant leukopaks for clinical use.
Consistency
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.
Detailed donor characterization
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.
Compliance
We are FDA Licensed for Blood Products, GMP/GLP compliant, CLIA Registered and CAP registered with accreditation pending
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 Genomics Center, which provides highly sophisticated analyses and high quality data meeting our customers’ turnaround time needs.
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
- T cells
- NK cells
- Dendritic cells
- Monocytes
- CD34+
| GMP Leukopak Product | Product No. | Total Cell Count | List Price |
|---|---|---|---|
| Full Leukopak | 960241 | 9.5 Billion Minimum | Contact Us for Pricing |
| Half Leukopak | 960242 | 5.5 Billion Minimum | Contact Us for Pricing |
| Quarter Leukopak | 960243 | 2.5 Billion Minimum | Contact Us for Pricing |
| 1/10th | 960244 | 1 Billion Minimum | Contact 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
- Hepatitis B Core Antibody (Anti-HBc 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*
- Trypanosoma cruzi Antibody*
- Syphilis*
- SARS-CoV-2, upon demand*
- Additional tests can be performed— please inquire.
* Unique to GMP Compliant Discovery Fresh Leukopaks
Frequently Asked Questions
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.
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?
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.
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.
A Primer on Human PBMCs
A quick reference resource for scientists who need to isolate, manipulate or develop assays involving human mononuclear cells.
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Questions? Call our Customer Service Team at 1 (866) 838-2798.
