Leukopaks

Leukopak is a product generated from Apheresis using the Continuous Mononuclear Cell Collection (CMNC) program of the spectra optia machine of Terumo. It contains a higher concentration of cells (ie, lymphocytes and monocytes) as compared to standard venipuncture collection methods and is used by researchers and manufacturers as starting material in the field of cell and gene therapy.

Available Leukopaks

Grifols Bio Supplies, offers different kinds of leukopaks collected under GMP-conditions in Germany and RUO leukopaks collected in the USA. 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: leukopak 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 immunphenotyping (CD3, CD4, CD8, CD14, CD19, CD56)
Donations from donors of all gender, blood groups, age, race and other characteristics are available
Backup donor scheduled for every donation
Recall donors

* Availability subjected to certain regions. For more information on donor collection services, please contact us

Fresh Leukopaks

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 offers fresh leukopaks with a high concentration of leukopcytes (≥ 40 x 10⁹ cells/L) which helps to cover large scale needs.

Specifications

Find the full specifications of Fresh Leukopaks below.

Specification

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, WNV (tested from June to November).

Viral Testing for USA Donors

: HBsAg, Anti-HIV Ag/Ab, HCV , HIV-1-NAT, HCV-NAT, HBV-NAT, RPR, WNV-NAT (tested from June to November) and syphilis

Donor Data Provided

: Age, gender, race, blood group and other

Format

: >170 mL

Anticoagulant

: ACD-A

Obtention Method

: Leukapheresis (Spectra Optia System)

Leukocyte Concentration

: ≥ 40 x 10⁹ cells/L

Platelet Concentration

: 1600 to 5200 x 10⁹/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

Specification
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, WNV (tested from June to November).
Viral Testing for USA Donors	HBsAg, Anti-HIV Ag/Ab, HCV , HIV-1-NAT, HCV-NAT, HBV-NAT, RPR, WNV-NAT (tested from June to November) and syphilis
Donor Data Provided	Age, gender, race, blood group and other
Format	>170 mL
Anticoagulant	ACD-A
Obtention Method	Leukapheresis (Spectra Optia System)
Leukocyte Concentration	≥ 40 x 10⁹ cells/L
Platelet Concentration	1600 to 5200 x 10⁹/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 Leukopaks

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 offers fresh leukopaks with a high concentration of leukopcytes (≥ 40 x 10⁹ cells/L) which helps to cover large scale needs.

Specifications

Find the full specifications of Fresh Leukopaks below.

Specification

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, WNV (tested from June to November).

Viral Testing for USA Donors

: HBsAg, Anti-HIV Ag/Ab, HCV , HIV-1-NAT, HCV-NAT, HBV-NAT, RPR, WNV-NAT (tested from June to November) and syphilis

Donor Data Provided

: Age, gender, race, blood group and other

Format

: >170 mL

Anticoagulant

: ACD-A

Obtention Method

: Leukapheresis (Spectra Optia System)

Leukocyte Concentration

: ≥ 40 x 10⁹ cells/L

Platelet Concentration

: 1600 to 5200 x 10⁹/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

Specification
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, WNV (tested from June to November).
Viral Testing for USA Donors	HBsAg, Anti-HIV Ag/Ab, HCV , HIV-1-NAT, HCV-NAT, HBV-NAT, RPR, WNV-NAT (tested from June to November) and syphilis
Donor Data Provided	Age, gender, race, blood group and other
Format	>170 mL
Anticoagulant	ACD-A
Obtention Method	Leukapheresis (Spectra Optia System)
Leukocyte Concentration	≥ 40 x 10⁹ cells/L
Platelet Concentration	1600 to 5200 x 10⁹/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