OUR
CONTRIBUTION

TO ALBUMIN

TAKEDA's ALBUMIN

has more than 70 years of experience.^2-4

This legacy is further defined by our safety measures throughout the plasma purification process.^1-6

Screening healthy and reliable plasma donors (BioLife^®).^1,4,5
Screening for HIV, HBV, HCV and HAV.^3-5
Meets the Plasma Protein Therapeutics Associationâ€™s voluntary Quality Standards of Excellence, Assurance and Leadership (QSEAL).³

To learn more about our human albumin visit our website

HIV: human immunodeficiency virus, HBV: hepatitis B virus , HCV: hepatitis C virus , HAV: hepatitis A virus

OUR FOCUS ON SAFETY THROUGHOUT COLLECTION AND PROCESSING

Takeda is committed to the highest standards of quality in plasma
collection and processing and the manufacture of life-saving therapeutics from plasma.¹⁰

Takeda employs a series of key processes to support safety, beginning with the collection of human plasma from donors and continuing through
production. Our processes have been certified by the Plasma Protein Therapeutics Association (PPTA) Quality Standards of Excellence, Assurance and Leadership (QSEAL) Voluntary Standard since 2001.¹¹

Our Rigorous Approach to Plasma Collection and Manufacturing

Takeda has the experience and the expertise to confidently manage the end-to-end challenges of developing complex, plasma-based therapeutics—from securing donations to delivering treatment.

Accurately predicting utilization for plasma-based therapeutics and meeting that demand can be a complicated process for manufacturers. At Takeda, we conduct rigorous analyses and manage multiple challenges that can impact albumin supply, including collections, manufacturing process, lead time, yield, and utilization of all plasma products.^12,13,14

Collections

Takeda operates more than ~260 state-of-the-art BioLife® plasma donation centers in the United States and Europe to help meet the growing need for plasma-based therapeutics.^9,15

REFERENCES

Flexbumin^® India Prescribing Information (PI).
Four-layer bag technology - Ref-35896- Baxter - May 2017.
Plasma Protein Therapeutics Association. Quality Standards of Excellence, Assurance and Leadership (QSEAL). Available at: https://www.pptaglobal.org/material/quality-standards-of-excellence-assurance-and-leadership-qseal Accessed July 2024.
World Health Organization. Recommendations for the production, control and regulation of human plasma for fractionation. WHO Technical Report Series. 2007: No. 941.
Virus Inactivation and Removal Steps - in House Development and Validation. Shire - Data on file (VV-MED-8499) August 2018.
Takeda Plasma-Derived Therapies. Available at: https://www.takeda.com/what-we-do/areas-of-focus/plasma-derived-therapies/ Accessed December 2020.
Liumbruno G, Bennardello F, Lattanzio A, Piccoli P, Rossettias G. Recommendations for the use of albumin and immunoglobulins. Blood Transfus. 2009;7(3):216-234.
Crawford A, Harris H. I.V. fluids: What nurses need to know. Nursing. 2011;41(5):30-38.
Marketing Research Bureau. The Plasma Proteins Market in the United States 2019. Published July 2020.
Data on file VV-MED-7520-FLEX-020 BioLife Press Kit 2012.
Plasma Protein Therapeutic Association. Quality Standards of Excellence, Assurance and Leadership (QSEAL) Program Certification Program 2010. https://www.pptaglobal.org/material/quality-standards-of-excellence-assurance-and-leadership-qseal Accessed May 2025.
Berman K. Plasma fractionation: the challenge of keeping pace with global IG demand. http://www.igliving.com/magazine/articles/IGL_2018-08_AR_Plasma-Fractionation-The-Chellenge-of-Keeping-Pace-with-Global-IG-Demand.pdf. Published August 2018. Accessed September 17, 2020.
U.S. Department of Health and Human Services. Analysis of supply, distribution, demand, and access issues associated with immune globulin intravenous (IGIV), final report. https://aspe.hhs.gov/pdf-report/analysis-supply-distribution-demand-and-access-issues-associated-immune-globulin-intravenous-igiv. Published February 1, 2007. Accessed September 17, 2020.
Rhodes RT. Immune globulin: controlling supply and demand. BioSupply Trends. 2015(Winter):14-18.
Document Source: Global BioLife Fact Sheet PDT-BSP-US-0981; C- ANPROM/INT/CORP/0085

OURCONTRIBUTION