GMP GMP

GMP Mobilized Leukopak

Reg H · fresh · 2 Paks

Apheresis from healthy donors who received FDA-approved drugs to mobilize CD34+ HSPCs from bone marrow into peripheral blood, for large-scale CD34+ yields. Collected on the Spectra Optia® system into ACD-A at FDA-registered, IRB-approved facilities.

Viability≥ 90%Fill≥ 280 mLShips2–8 °C
A technician carries a cryo rack through the lab
Specifications

Product specifications

Catalog numbers
CG, mLP, RegH, FR, Full Pak · Full Pak 2
Mobilization
G-CSF 10 µg/kg/day SC × 5 days + plerixafor 240 µg/kg SC × 2 days
Format
Fresh, 2 Paks
Anticoagulant
ACD-A
Viability
≥ 90%
Fill volume
≥ 280 mL
Sterility (USP <71>)
No growth
Shipping
2–8 °C, validated container with temperature logger
Documentation
Certificate of Analysis, Summary of Records
COAEvery GMP order ships with a Certificate of Analysis and Summary of Records. Ask your account manager for a sample CoA before you place a qualification order.
The difference

AllCells GMP mobilized difference

01

RUO to GMP, one product line

Develop your process on RUO material, then move to GMP without changing starting material.

02

99% deliverability

Avoid delays with a 99% deliverability rate for GMP products.

03

Up to 5 collections per donor

Repeat mobilized collections from the same donor keep manufacturing consistent.

Donors

Keep the same donor across batches

Donor Management Services

Find, screen and retain donors from a repository of highly characterized, HLA-typed donors with diverse demographics and clinical parameters, from R&D through commercialization.

Donor Management
Request a quote

Request a quote

Tell us what you need. A CGT specialist replies within one business day with pricing, lead time and donor availability.

  • Standard leukopak orders ship in as little as 3 business days
  • Same-day fresh delivery in the San Francisco Bay and Boston metro areas
  • Every order ships with a certificate of analysis

Prefer email? support@dls.com

01 · Contact
02 · Material
03 · Donor requirements
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