Host Cell Protein (HCP) Immunoassays and Role of Mass Spectrometry in Identification of HCP Impurities in Downstream Samples

How can you better identify those host cell proteins (HCPs) that might co-purify with your drug substance (DS) and elicit an undesired immune response, interfere with drug safety and efficacy, or impact DS stability? Cygnus Technologies VP of R&D, Eric Bishop, discusses powerful orthogonal methods such as immunoaffinity chromatography and mass spectrometry that enable full understanding of those HCPs that are present in the product and could potentially impact patient safety and drug stability.

Cygnus AAE™ - MS services

HCP Analysis by AAE™ and Mass Spectrometry Antibody Affinity Extraction™ (AAE™) is a superior alternative to 2D Western blot for the determination of polyclonal anti-HCP coverage and reactivity to individual HCPs. Learn how using AAE™ with Mass Spec can help identify HCPs that often persist through the purification process.

Cygnus - Predicting Viral Clearance

Predicting Viral Clearance: DOE, HTS and AAV Case Studies Using a Non-Infectious MVM Surrogate in Downstream Development

Host Cell Protein Analysis by ELISA and Orthogonal Methods in Vaccine and Gene Therapy Development

Next generation recombinant vaccines and gene therapy products require clinical and commercial manufacturing of protein antigens and/or viral vectors produced using cell culture technologies. In this webinar, we discuss orthogonal Antibody Affinity Extraction (AAE™) and Mass Spectrometry (MS) methods used to assess ELISA Ab coverage to HCPs present in a process and identify process-specific HCP that may co-purify with a drug substance. Case studies of HEK 293, Sf9 and Vero cell-based processes are presented.

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