BioPharma Safety Assays

Overview

BioPharma Safety is one of four key focus areas for Bioassay GmbH laboratories, along with BioPharma Efficacy, BioPharma Potency and Chemicals/Cosmetics Safety.

Bioassay’s analytical team, operating in-vivo and in-vitro facilities with state-of-the-art-equipment at the company’s 1000 m2 laboratories at Heidelberg Technology Park, can execute and assess safety assays within quality control and development regimes for a wide range of complex biopharmaceuticals and biotherapeutics.

Biopharma Safety Assays

Complex biotherapeutics interact with many different molecules in the human body to develop their mode of action. This increases the possibility of unwanted effects that might result in an unacceptable safety profile or compromise therapeutic efficacy of a compound. Bioassay offers a panel of assays for assessment of monoclonal antibodies (mAbs) to any kind of recombinant proteins to characterize biotherapeutics in this respect.

Safety assay panels

Bioassay offers a panel of assays for assessment of complex biotherapeutics ranging from mAbs to recombinant proteins to characterize their interaction with different molecules in the human body to filter out possibilities of unwanted effects that might prejudice safety profile or compromise therapeutic efficacy.

Bioaasay offers a range of relevant biologics safety panels covering:

• Antibody-dependent cellular cytotoxicity (ADCC)
• Neutralizing antibodies
• Multi-Cytokine Analysis
• Immunotoxicity (iTox3)
• Skin sensitization tests (LLNA, h-Clat, Keratinosens & MUSST)
• Toxicokinetics

Compliance and transparency

Bioassay conducts and documents all biopharma safety assays in conformity with GLP & GMP standards, which form the basis for its quality and reliability standards. This compliance guarantees acceptability of data generated for product acceptance and licensing.

Bioassay quality standards are inspected by leading regulatory authorities and in customer audits. These serve to encourage continuous improvement and reinforce transparency.

All customer-specific data and processes are handled and stored with utmost discretion and confidentiality.

Resources

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Click on Bioassay to contact the company directly.