mononuclear cells in every leukopak
< 48 hours
from collection to delivery
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.
Key Reasons Why You Should Consider Discovery Cryo Leukopaks
- 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.
- Know the cell populations, HLA-Type, demographics, and real-time virus data when you select your Discovery Cryo Leukopak.
- Avoid wasted resources on a planned manufacturing run due to failed donor collection or logistics challenges
With 2,800+ recallable leukapheresis donors, we can support any scale project with high-quality, GMP compliant leukopaks for clinical use.
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.
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.
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.
CONSULTATIVE CELL SERVICES
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
- NK cells
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.
All cells are obtained using IRB approved consent forms and protocols.
We perform extensive characterization of all donors that includes:
- Smoking status
- Blood type
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
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.
Frequently Asked Questions
How long until I receive my first shipment of Discovery Cryo Leukopaks?
Do you have a specific thawing protocol?
What cryopreservation protocol do you follow?
Where are your sites?
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.
How do you facilitate the transition between RUO and GMP?
Our integrated project management approach facilitates the transition between research and clinical phases. Client-specific donor pools provide premier access and flexibility for GMP and RUO collections.
Has COVID-19 affected your collection, processing, and/or analytical facilities?
What anticoagulant do you use for Discovery Leukopaks™?
What apheresis equipment do you use?
Which collection protocol/program and consumable sets are you using?
How often can you perform apheresis on a specific donor?
To propel your projects with The Power of Discovery.™
Contact Us Today
Let us know about your project!