Biosimilars & Antibody Drug Conjugates PDF
Preview Biosimilars & Antibody Drug Conjugates
Agilent’s Solutions for: Biosimilars & Antibody Drug Conjugates Gurmil Gendeh, Ph.D. & Biopharma Biosimilars Markets Life Sciences Group Agilent Technologies 1 Outline • Biopharma Market, Workflows & Analytical Challenges • Biosimilars – Definitions & Regulations – How similar is similar enough – Case study: Comparability data between a biosimilar and its innovator reference • ADCs – Rational – Heterogeneity in ADC – Key quality attributes and analytical methods for ADCs • Summary Agilent Confidential 2 June 9, 2014 Outline • Biosimilars – Definitions & Regulations – How similar is similar enough – Case study: Comparability data between a biosimilar and its innovator reference • ADCs – Rational – Heterogeneity in ADC – Key quality attributes and analytical methods for ADCs • Summary Agilent Confidential 3 June 9, 2014 Traditional Pharma business model is changing It’s a mAb! It’s a large Pharma! Confidentiality Label June 9, 2014 4 Big Pharma – becoming Big Biopharma Confidentiality Label June 9, 2014 5 Biologics in development by product category and development phase mAb Dominates – 3 out of 4 Protein Therapeutics are mAbs Pharma 2013 Report, Medicines in Development – Biologics Confidentiality Label June 9, 2014 6 Biologics medicines – by Therapeutic categories mAbs for Cancer therapeutics dominates Pharma 2013 Report, Medicines in Development – Biologics Confidentiality Label June 9, 2014 7 Confidentiality Label June 9, 2014 8 Biologics manufacturing is highly complex & requires analysis at every step Establishment of genetically engineered cells (e.g. CHO) that produce desired product DNA Vector Human gene Biomarker ID & validation HT Clone mAb Generation Cell Culture Scale-up & Production Screening & Platform Selection e.g. transgenic mice “the process is the product” Centrifuge Market Manufacturing Clinical Pre-clinical Chromatography Chromatography Chromatography Column #3 Column #2 Column #1 Formulation Downstream Processing & Purification Confidentiality Label June 9, 2014 9 Analytical groups are tasked with methods development, sample analysis & methods transfer Establishment of genetically engineered cells (e.g. CHO) that produce desired product DNA Vector Human gene Biomarker ID & validation HT Clone mAb Generation Cell Culture Scale-up & Production Screening & Platform Samples Selection e.g. transgenic mice Samples Samples Samples Analytical Groups Develop analytical methods; Centrifuge analyze samples from other QA/QC Methods functions, methods transfer Samples Samples Market Manufacturing Clinical Pre-clinical Chromatography Chromatography Chromatography Column #3 Column #2 Column #1 Formulation Downstream Processing & Purification Confidentiality Label June 9, 2014 10
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