Sequential isolation
The Donor Difference
Counting protocolGMP Cryopreserved Leukopak
Collected from consented donors who meet FDA 21 CFR 1271 requirements and cryopreserved in an adjacent GMP ISO 7 cleanroom. Made-to-stock from standard eligible donors, or made-to-order against your program's donor attributes and infectious disease marker testing.
Product specifications
- Catalog number
- CG, LP, CR, Solo; 2.5–3.0 B
- Anticoagulant
- ACD-A
- Bag format
- OriGen CS250, 70 mL target
- Cryopreservation medium
- CryoStor® CS10
- Pre-cryo TNC
- ≥ 2.5 × 10⁹ cells per bag
- Pre-cryo viability
- ≥ 90%
- Retain vials
- Up to 8
- Sterility (USP <71>)
- No growth
- Shipping
- Below −150 °C, validated container with temperature logger
- Documentation
- CoA, Summary of Records, immunophenotype report, CBC 5-part differential
Our GMP cryopreserved leukopak difference
Same product line
Process development on RUO, manufacturing on GMP.
Fast to freeze
Short collection-to-processing time and validated cryopreservation: high viability, low granulocyte contamination.
Donor retention
Screening and retention built for downstream success.
Off the shelf
Inventory from donors meeting 21 CFR 1271.
Built next to the donor clinic
GMP cleanroom
All cryopreservation happens in an ISO 7 cleanroom with Grade A and B zones, executed against the Master Batch Record, next door to the collection facility.
- Environmental monitoring, step-down suites and one-way product flow
- Cryogenic storage with continuous temperature monitoring and alarms
- Dedicated staff and equipment management
Resources
Protocols, webinars and articles from our scientists. Technical questions go straight to the Customer Success Team.