Quality & Safety | Business Unification

Overview

Baxter’s global biologics business is fully unified and includes discovery, development, manufacturing and operations and commercial businesses. Unification helps to ensure product efficacy, quality, and compliance with regulatory requirements. As a fully unified business, the highest quality standards are met in every step of product development, from plasma donations and manufacturing, which includes virus reduction, to after the product reaches the patient.

Quality

Baxter’s BioScience business aims to provide safe and effective therapies. From data documentation to product surveillance, the company has developed and facilitated the effective implementation of world-class quality systems to ensure highest quality for Baxter customers.

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Baxter Plasma Safety

Baxter's immunoglobulin products are processed by human plasma collected only at Food and Drug Administration (FDA)-registered blood establishments.

Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and processing to the patient.

	Donors Before a donor can donate plasma at Biolife Plasma Centers, the donor must pass a medical examination and survey of their medical history. The screening process is required every time a donor returns and each donor is subsequently screened for infectious diseases, including Human Immunodeficiency Virus (HIV) and Hepatitis B.
	Donation test, hold, ship Individual donations are tested for viral markers [HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)] and shipped to a storage facility and held for a period of time. Donations not meeting strict standards are discarded.
	Additional testing Once the plasma donations are released from the holding period and received at the manufacturing plant, the individual samples are then pooled together and tested once again for viral markers.
	Manufacturing In addition to attentive screening of the plasma, the product then goes through additional, validated virus-removal/virus-inactivation steps during the manufacturing process.
	Patient The final product, which meets highest quality standards, is infused into the patient.

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Plasma Fractionation Expertise

Baxter’s BioScience business has manufacturing expertise in plasma fractionation technology.

Plasma fractionation

Baxter’s plasma fractionation method is increasingly more efficient and helps improve product yields from plasma donations. Plasma contains thousands of different therapeutic proteins, and fractionation concentrates the necessary proteins. The company’s experience in plasma fractionation has resulted in the development of reliable and innovative therapies that ensure the treatment of various chronic conditions.
To view the fractionation chart, please click here.

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Additional Safety Steps

BioTherapeutic's virus inactivation capabilities:

• Solvent/detergent (S/D) process to inactivate lipid-enveloped viruses by removing the lipid coating that is needed for the virus to survive.
• 35 nm nanofiltration to further filter and eliminate smaller viruses.
• Low-pH incubation at high temperatures to target viruses that may or may not have a lipid coating.

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