Biosimilars & Antibody Drug Conjugates

72 Pages·2014·18.78 MB·English

Agilent’s Solutions for:

Biosimilars & Antibody
Drug Conjugates

Gurmil Gendeh, Ph.D.
&
Biopharma Biosimilars
Markets

Life Sciences Group
Agilent Technologies

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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!
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Big Pharma – becoming Big Biopharma
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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
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Biologics medicines – by Therapeutic categories
mAbs for Cancer therapeutics dominates
Pharma 2013 Report, Medicines in Development – Biologics
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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
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June 9, 2014
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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
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