Plasma- & Urine-Derived Proteins

Essential therapeutics in today’s treatment regimen

Plasma- or urine-derived medicines are manufactured from human or animal blood or urine. These products are used to treat and prevent numerous serious diseases including clotting disorders, immune deficiencies, fertilization treatment and other hormonebased treatments.

Given the high risk of virus contamination of these products, stringent controls are needed for sourcing the starting materials from donors. Further, orthogonal steps in the manufacturing process must be validated for effective virus and prion removal or inactivation.

ViruSure provides expert support to manufacturers of such products both via risk assessments as well as the performance of virus and prion clearances studies to confirm the reduction capacity of the purification process.

ViruSure offers the following services
for producers of plasma/urine-derived proteins:

Process Validation Studies
Plasma- & Urine-Derived Proteins

Virus Clearance Studies

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Prion Clearance Studies

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Pathogen Safety Testing

Molecular Tests (e.g. qPCR)

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Potency Studies

In Vitro Potency Studies

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In Vivo Potency Studies

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Consultancy

Consultancy + Risk Assessments

Let's Talk About Your Plasma- & Urine-Derived Proteins

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