Macromolecules in E-Workbook

Transcription

1 Macromolecules in E-Workbook Ian Peirson March 2018

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3 So what do we mean by macromolecules?

4 Small molecules MW<700Da, chemically synthesised, oral dosage, penetrates cell membranes for induced effect (systemic) Small Simple Vincristine Madagascar periwinkle

5 Large molecules MW 1-200kDa, manufactured by cell line fermentation processes, bind to cell receptor (highly specific) Classic examples: Insulin Antibody

6 but there are new hybrid forms of biomolecules Novel (unnatural) peptides Peptide/phospholipid-drug conjugate Antibody-drug conjugate sirna

7 Challenges to the workplace No longer chemist vs biologist mindset! Chemists need to think like biologists (and vice versa) Joint work is critical to success Chemists have to synthesise unnatural monomers (or full sequences) Know how to handle these types of molecules Identify appropriate linkers (stability, toxicology) Joint engineering of drug/biomolecule ratio

8 What s the Market interest? FDA approval for biological vs small molecules has increased annually from 35% in 2005 to 42% in 2015 Biologics accounted for six of the top eight drugs by revenues in 2017 Growth in biological drugs is estimated at 10.7% CAGR Global biologics market expected to reach $386.7 billion by the end of 2019 The global antibody-drug conjugates market is expected to reach $4.6bn by 2017, growing at 30.5% CAGR

9 So what s needed? Rendering in experiments Workflow and data management Registration Inventory Management Genealogy

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11 Biology What about data management? Rendering Registration Inventory Geneology Conclusion Nod to HeLa

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13 Data Management: Rendering What about data management? Rendering Registration Inventory Geneology Conclusion Nod to HeLa

14 Biology What about data management? Rendering Registration Inventory Geneology Conclusion Nod to HeLa

15 Process Development Research USP - Microbial DSP Formulation Development Primary Packaging Manufacturing MFCS YSI, Bioprofile Spectrophotometer UNICORN MODDE/ SIMCA Robot DMS Cell Expansion Bioreactor Experiment Cross-Batch Comparison Purification Development Study Setup / Material Processing Analysis / Interpretation Primary Packaging Development Sample ID Sample ID Timepoint Report Final Report MFCS, ambr USP Cell Culture ViCell, phox JMP Sample Management Clinical Supply Support Cell Expansion Bioreactor Experiment Cross-Batch Comparison Sample Inventory GMP: Method Validation Sample ID Sample ID LIMS BioAssay In Process Analytics Characterization Method Development ELISA BioAssay Chromatography Methods Spectrophotometric Methods Mass Spectrometry Methods Electrophoretic Methods Characterization Method Development SoftMax Pro JMP Empower Lab Instruments SDMS Lab Instruments LIMS Inventory Management Equipment / Column Management Purchased Materials Media/Buffer Preparation Reference Standards/ Controls Registered Columns Equipment Usage Asset Mgmt Material ID Material ID Material ID Column ID Equipment ID

16 Workflow Import data Adapt instructions to a specific scenario Configurable spreadsheets for workflows Integrate laboratory instruments Set up required reports Modify calculations as necessary

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18 and use in EWB experiments

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23 Genealogy Chemical: Batches Product Containers Registration Salt form Biological: DNA Sequence Restriction Enzyme Vector Plasmid Cell line Expressed protein Protein sequence Protein Species Purification

24 Completing the circle: Unified chemical and biological rendering & registration Enhancing Bio-inventory for visualisation and reporting of biological genealogy With our customers We use forums in US and EU to drive the products forward: Chemistry Forum next one April 2018 (US&EU) Biomolecule Forum next one May 2018 Search Forum Feb 2018, next one May 2018

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