John Chappell | Application And Service Director Emea And Asia Pacific
Gyros Protein Technologies

John Chappell, Application And Service Director Emea And Asia Pacific, Gyros Protein Technologies

John Chappell has approximately 25 years of experience in the biopharmaceutical industry supporting both preclinical and clinical drug development.  He has specialized in supporting biological compounds from an analytical perspective e.g. Pharmacokinetic, Immunogenicity and Biomarker analysis and is particularly interested in validation requirements and ensuring that data generated will be acceptable to the regulatory authorities.
John leads the Application Support and Service teams for Gyros Protein Technologies, responsible for customer service and technical support in Europe and the Asia Pacific regions. He has been a user of the Gyrolab system for over 10 years and uses his experience to help customers. John has spoken at many international conferences on various topics including Oligonucleotide analysis, Biomarker Analysis, Immunogenicity and the analytical support of Biosimilar programs.  He is a Fellow of the Royal Society of Chemistry and was involved in the American Association of Pharmaceutical Scientists (AAPS) Biosimilar Committee that has prepared papers on Pharmacokinetic and anti-drug antibody assays.

Appearances:



Festival of Biologics Day 1 @ 14:20

Accelerating bioprocess workflows with microfluidic, immunoassay-based parallel impurity analysis

Impurities in biologics cell culture manufacturing and bioprocess purification steps such as host cell proteins (HCPs), culture-related impurities, and process-related impurities can potentially reduce therapeutic efficacy and cause immunogenic reactions in patients. Minimizing the level of impurities during bioprocess development is therefore a critical regulatory requirement. Gyrolab® Systems have become established analytical tools for performing immunoassay-based bioprocess impurity bioanalysis in a regulated environment. The unique microfluidic, flow-through assay format dramatically reduces reagent and sample volumes and eliminates long incubation times common in ELISAs routinely used for impurity analysis. Here we present data on the quantitation of a variety of impurities found in bioprocess samples including Chinese Hamster Ovary (CHO) cell line HCPs and insulin cell culture impurities using Gyrolab assay kits and protocols. Results demonstrate dynamic range, precision, dilutional linearity, and spike data that fulfills key regulatory bioanalytic method requirements and is comparable or superior to ELISA methods.
last published: 17/Sep/21 16:05 GMT
last published: 17/Sep/21 16:05 GMT
last published: 17/Sep/21 16:05 GMT
last published: 17/Sep/21 16:05 GMT

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