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Regulatory & Safety

According to global regulatory standards, plasma therapeutics must have a certain product quality and impurity profile. With the industry facing ever increasing regulations for risk assessment, quality and purity, we’ve broadened the scope of our portfolio to help you meet the latest requirements and speed your way through the regulatory maze.

Associated Products
The Emprove® Program
Our program has been providing efficient regulatory documentation to the pharma and biopharma industry for over a decade, even as the number of regulations has increased.

Eshmuno® P anti-A & Eshmuno® P anti-B Chromatography Resins
Affinity based chromatography resins specifically designed to effectively remove anti-A and anti-B isoagglutinin antibodies from plasma-derived Immunoglobulin (Ig) therapeutics.

Virus Safety
Regulatory guidance advocates virus control at various stages of the manufacturing process. Partnering with a company that can assist you through all of these critical steps is an important factor.  

Application & Tools
Detergents REACH Compliance Alternatives
Download our full statement on The Inclusion of Alkylphenol Ethoxylates in Annex XIV including a list of suggested alternatives.

Sterile Filtration Selection Guide
Interactive configuration tool to help find the recommended filter and its associated documentation for each unit operation in your process.