Leukopaks

Leukopak is a blood-derived product generated from apheresis, rich in mononuclear leukocytes (ie, lymphocytes and monocytes)¹ and is used by researchers and manufacturers as starting material in the field of cell therapy.

The product presented here is not for therapeutic use

Fresh Leukopaks

Grifols Bio Supplies offers fresh leukopaks collected under GMP conditions and for Research Use Only (RUO) in Europe, and Research Use Only (RUO) leukopaks in the US. The high collection capabilities of Grifols and its expertise on apheresis secures the procurement of many initial materials for future large-scale manufacturing processes of CAR-T therapies.

Fresh leukopaks are collected from healthy donors without any further manufacturing steps. Fresh leukopaks are shipped within 24 hours and need to be immediately used.

Leukopak Donor Collection Program

From our robust donor network in Germany and in the USA, donors fulfilling the requirements for leukopak donations are approached to be enrolled within the leukopak donation program. All donations and manufacturing of the product in Europe is done according to the German guidelines for Collection and Processing of Blood and Blood Components (“Hämotherapierichtlinie”) as well as the PPTA Qualified Donor standard and internal SOPs. A manufacturing license as well as a GMP certificate is granted to all donor centers in Germany. All donations and manufacturing of the product in the USA is done according to the FDA guidelines for Collection and Processing of Blood and Blood components and internal SOPs. All our donor centers are regularly inspected by authorities and customers.

Collection services*:

Viral testing and measurement of cell concentration for every donation
Option to perform immunophenotyping (CD3, CD4, CD8, CD14, CD19, CD56)
Donations from donors of all genders, blood groups, ages, races and other characteristics are available
Backup donor scheduled for every donation
Recall donors

Fresh leukopaks provided by Grifols are collected from our robust and well-characterized donor pool with a backup donor system which secures the availability of the donation on the scheduled day. Grifols Bio Supplies offers high-quality leukopaks containing a rich concentration of leukocytes (≥ 40 x 109 cells/L) which helps to cover large-scale needs. Product customization is available upon request.

* Availability is subject to certain regions. For more information on donor collection services, please get in touch with us.

Fresh Leukopak Specifications

Origin of Leukopaks

: Europe (Germany) or USA

Donor Criteria

: Donors have an approved consent for donating blood. All donors are screened to ensure that each of them is in good health condition and that products are not collected from a high-risk population for blood-borne infections

Viral Testing for European Donors

: Each donation is tested for the following viral markers: Serologically tested: non-reactive for HBsAg, anti-HBc, HIV-Ag/Ab, HCV-Ab and syphilis. NAT tested: non-reactive for HIV-1; HCV; HBV; HAV; PVB19, HEV.

Viral Testing for USA Donors

: Each donor is tested for the standard FDA viral markers and found negative Anti-HIV Ag/Ab, HBsAg, Anti-HCV, HTLV I/II, Treponema, Pallidum Antibodies, Anti-HBc, Atypical Antibody, HIV-1 RNA/HBV DNA/HCV RNA, WNV-NAT, Chagas (performed on the donor's first donation)

Donor Data Provided

: Age, gender, race, blood group and other

Format

: >170 mL

Anticoagulant

: ACD-A

Obtention Method

: Leukapheresis

Leukocyte Concentration

: ≥ 40 x 10⁹ cells/L

Hemoglobin Concentration

: ≤ 0.5 mmol/L

Monocyte Concentration

: ≥ 5 x 10⁹ cells/L

Lymphocyte Concentration

: ≥ 28 x 10⁹ cells/L

Use

R&D Cell Therapy
Source of PBMCs

Grade

: Research use

Fresh Leukopak Specifications
Origin of Leukopaks	Europe (Germany) or USA
Donor Criteria	Donors have an approved consent for donating blood. All donors are screened to ensure that each of them is in good health condition and that products are not collected from a high-risk population for blood-borne infections
Viral Testing for European Donors	Each donation is tested for the following viral markers: Serologically tested: non-reactive for HBsAg, anti-HBc, HIV-Ag/Ab, HCV-Ab and syphilis. NAT tested: non-reactive for HIV-1; HCV; HBV; HAV; PVB19, HEV.
Viral Testing for USA Donors	Each donor is tested for the standard FDA viral markers and found negative Anti-HIV Ag/Ab, HBsAg, Anti-HCV, HTLV I/II, Treponema, Pallidum Antibodies, Anti-HBc, Atypical Antibody, HIV-1 RNA/HBV DNA/HCV RNA, WNV-NAT, Chagas (performed on the donor's first donation)
Donor Data Provided	Age, gender, race, blood group and other
Format	>170 mL
Anticoagulant	ACD-A
Obtention Method	Leukapheresis
Leukocyte Concentration	≥ 40 x 10⁹ cells/L
Hemoglobin Concentration	≤ 0.5 mmol/L
Monocyte Concentration	≥ 5 x 10⁹ cells/L
Lymphocyte Concentration	≥ 28 x 10⁹ cells/L
Use	R&D Cell Therapy Source of PBMCs
Grade	Research use

Fresh Leukopak Specifications

Origin of Leukopaks

: Europe (Germany) or USA

Donor Criteria

: Donors have an approved consent for donating blood. All donors are screened to ensure that each of them is in good health condition and that products are not collected from a high-risk population for blood-borne infections

Viral Testing for European Donors

: Each donation is tested for the following viral markers: Serologically tested: non-reactive for HBsAg, anti-HBc, HIV-Ag/Ab, HCV-Ab and syphilis. NAT tested: non-reactive for HIV-1; HCV; HBV; HAV; PVB19, HEV.

Viral Testing for USA Donors

: Each donor is tested for the standard FDA viral markers and found negative Anti-HIV Ag/Ab, HBsAg, Anti-HCV, HTLV I/II, Treponema, Pallidum Antibodies, Anti-HBc, Atypical Antibody, HIV-1 RNA/HBV DNA/HCV RNA, WNV-NAT, Chagas (performed on the donor's first donation)

Donor Data Provided

: Age, gender, race, blood group and other

Format

: >170 mL

Anticoagulant

: ACD-A

Obtention Method

: Leukapheresis

Leukocyte Concentration

: ≥ 40 x 10⁹ cells/L

Hemoglobin Concentration

: ≤ 0.5 mmol/L

Monocyte Concentration

: ≥ 5 x 10⁹ cells/L

Lymphocyte Concentration

: ≥ 28 x 10⁹ cells/L

Use

R&D Cell Therapy
Source of PBMCs

Grade

: Research use

Fresh Leukopak Specifications
Origin of Leukopaks	Europe (Germany) or USA
Donor Criteria	Donors have an approved consent for donating blood. All donors are screened to ensure that each of them is in good health condition and that products are not collected from a high-risk population for blood-borne infections
Viral Testing for European Donors	Each donation is tested for the following viral markers: Serologically tested: non-reactive for HBsAg, anti-HBc, HIV-Ag/Ab, HCV-Ab and syphilis. NAT tested: non-reactive for HIV-1; HCV; HBV; HAV; PVB19, HEV.
Viral Testing for USA Donors	Each donor is tested for the standard FDA viral markers and found negative Anti-HIV Ag/Ab, HBsAg, Anti-HCV, HTLV I/II, Treponema, Pallidum Antibodies, Anti-HBc, Atypical Antibody, HIV-1 RNA/HBV DNA/HCV RNA, WNV-NAT, Chagas (performed on the donor's first donation)
Donor Data Provided	Age, gender, race, blood group and other
Format	>170 mL
Anticoagulant	ACD-A
Obtention Method	Leukapheresis
Leukocyte Concentration	≥ 40 x 10⁹ cells/L
Hemoglobin Concentration	≤ 0.5 mmol/L
Monocyte Concentration	≥ 5 x 10⁹ cells/L
Lymphocyte Concentration	≥ 28 x 10⁹ cells/L
Use	R&D Cell Therapy Source of PBMCs
Grade	Research use

Product availability vary by country. For more information on product availability, please contact us.

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The information contained in these webpages are intended for a professional audience of pharmaceutical and in vitro diagnostic manufacturing personnel. All products are intended for research and development and manufacturing usage.

Availability of the products are subjected to certain regions. For more information, please contact us

Reference

Garcia A, Keinonen S, Sanchez AM, et al. Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs. J Immunol Methods. 2014;409:99-106.