Grifols is committed to quality

Grifols owns one of the largest plasma collection networks in the world, and is committed to ensuring that its products meet excellent quality standards and are available to the patients who need them.

One of the largest plasma collection networks in the world, with a production capacity you can rely on1

39,000 Daily Donors
  • 39,000 daily donors
    • Every day, an average of 39,000 individuals donate plasma at one of Grifols' plasma donation centers across the US, forming one of the largest plasma collection platforms in the world

 

 

  • >10,000,000 yearly donations
    • Grifols performs more than 100 million screening tests* on plasma donations each year

*Grifols' internal source 2018

Grifols is one of the world's largest providers of plasma-derived therapies with its own vertically integrated supply of plasma, which helps ensure continuous production of Flebogamma® DIF

  • Grifols owns and operates an extensive network of donation centres
  • Plasma donation centers and all the processes for obtaining, analyzing, and storing plasma are regulated by standard procedures established by US and/or European Health Authorities
  • The production cycle for plasma therapies from donation to final product takes several months, depending on the fraction from which the therapy is derived and the complexity of the production method2

Flebogamma® DIF is made from plasma that meets FDA and/or EMA standards and additional safety and quality measures set by Grifols

This extensive quality and safety testing ensures a broad safety margin for the plasma used in the production of Flebogamma® DIF

  • The inventory hold and look back steps give Grifols the opportunity to discard donations from any donor who was turned away because of a seroconversion in subsequent donations
  • Each donation is computer checked again before it is sent for plasma derivatives production, which guarantees that each donation has satisfied all controls
 
Doctor and Patient with questionnaire

Selected donors

All donors thoroughly screened and tested

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Identification and verification by barcodes

Full traceability from each donation to final product

Immunoassay (ELISA) testing for each donation

Immunoassay (ELISA) testing for each donation

Each unit is tested by ELISA for HBsAg, HIVAb, and HCVAb

Minipool Nucleic Acid Testing (NAT)

Minipool nucleic acid testing (NAT)

NAT testing in minipools of ≤512 units for HIV, HBV, HCV, HAV, and virus B19

Inventory-hold and look-back

Inventory hold and look back

Every unit of plasma is held in inventory for 60 days before being released into production

Final computer verification

Final computer verification

The only way plasma is released

ELISA, enzyme-linked immunosorbent assay; HAV, hepatitis A virus; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; HCVAb, hepatitis C virus antibody; HIV, human immunodeficiency virus; HIVAb, human immunodeficiency virus antibody.

Flebogamma® DIF is registered in more than 40 countries

Grifols is committed to assuring continued access of IVIG to the people around the world who depend on this life enhancing medicine

Countries where Flebogamma DIF is registered

All IVIGs are not the same; the process makes the product2

Each IVIG manufacturer has its own unique process

Each IVIG manufacturer has its own unique:

  • Production process
  • Pathogen elimination methods
  • Final formulation and composition

This makes each product different

For this reason, clinical outcomes, including both safety and efficacy, might also differ among brands2

Dual inactivation (pasteurization and solvent/detergent treatment) and nanofiltration (20 nm) provide peace of mind for you and your patients3-5

The Flebogamma® DIF production process includes 3 validated specific pathogen-elimination steps, providing a broad safety margin4,5

Steps in pathogen elimination

In addition to these 3 validated specific steps, the process involves 4 validated non-specific pathogen reduction steps (fraction I precipitation, incubation during fraction II and III precipitation, PEG precipitation, and acid pH treatment)4,5

References:

  1. Data on File. Instituto Grifols, S.A.
  2. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6(4):592-599.
  3. Siegel J. Immune globulins: therapeutic, pharmaceutical, cost, and administration considerations. Pharmacy Practice News. Special Edition, Educational Reviews. January 2014.
  4. Belda FJ, Caballero S, Díez JM, et al. Study of Planova™ 20N nanofiltration as applied to Flebogamma DIF. In: Etzioni A, Gambineri E, editors. Proceedings of the 15th Meeting of the European Society of Immunodeficiencies; October 3-6, 2012, Florence, Italy.
  5. Jorquera JI. Flebogamma 5% DIF development: rationale for a new option in intravenous immunoglobulin therapy. Clin Exp Immunol. 2009;157(suppl 1):17- 21.
  6. Jose M, Marzo N, Bono M, et al. Pasteurization inactivates clotting enzymes during Flebogamma and Flebogamma DIF production. WebmedCentral Immunotherapy. 2011;2(5):WMC001917. doi: 10.975/journal.wmc.2011.001917.