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Macromolecules in E-Workbook
Ian PeirsonMarch 2018
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So what do we mean by macromolecules?
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• MW<700Da, chemically synthesised, oral dosage, penetrates cell membranes for induced effect (systemic)
• Small ≠ Simple
Small molecules
Vincristine Madagascar periwinkle
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• MW 1-200kDa, manufactured by cell line fermentation processes, bind to cell receptor (highly specific)
• Classic examples:
Large molecules
Insulin Antibody
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…but there are new hybrid forms of biomolecules
Novel (unnatural) peptides Peptide/phospholipid-drug conjugate
Antibody-drug conjugatesiRNA
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• 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
Challenges to the workplace
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• 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
What’s the Market interest?
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• Rendering in experiments• Workflow and data management• Registration• Inventory Management• Genealogy
So what’s needed?
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Biology
What about data management?RenderingRegistrationInventoryGeneology
ConclusionNod to HeLa
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Data Management: Rendering
What about data management?RenderingRegistrationInventoryGeneology
ConclusionNod to HeLa
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Biology
What about data management?RenderingRegistrationInventoryGeneology
ConclusionNod to HeLa
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Research
Cell ExpansionBioreactor
Experiment
Purchased
Materials
Reference
Standards/
Controls
Sample ID
Media/Buffer
Preparation
Registered
Columns
Timepoint
Pur ification
Development
Column ID
Sample
Inventory
Material ID Material ID
SDMSEmpowerLab
Instruments
UNICORNMFCS
Bioreactor
Experiment
Equipment
Usage
DMS
Asset Mgmt
Study Setup /
Material
Processing
Analysis /
Interpretation
ELISA BioAssay
SoftMax
Pro
RobotYSI,
Bioprofile
JMP
MODDE/
SIMCA
Material ID
Cell Expansion
ViCell,
pHOx
Chromatography
Methods
Mass
Spectrometry
Methods
Spectro-
photometric
Methods
JMP
Sample ID
Cross-Batch
Comparison
Report
LIMS
Spectro-
photometer
USP - Microbial
MFCS,
ambr
USP – Cell Culture
Manufacturing
Sample ID
Cross-Batch
Comparison
Sample ID
Primary
Packaging
Development
DSP
Final Report
Primary PackagingFormulation Development
BioAssay
Inventory Management
Equipment ID
Equipment / Column Management
Lab
Instruments
In Process Analytics
CharacterizationMethod
Development
Process Development
Sample Management
Electrophoretic
Methods
Characterization Method Development
LIMS
GMP: Method
Validation
Clinical Supply Support
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Configurable spreadsheets for
workflows
Modify calculations as necessary
Adapt instructions to a specific
scenarioImport data
Integrate laboratory
instruments
Set up required reports
Workflow
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and use in EWB experiments
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Genealogy
Chemical:
Product
Batches
Containers
Biological:
DNAVector
Cell line
RestrictionEnzyme
Sequence
PlasmidExpressedprotein
Proteinsequence
ProteinSpecies
Salt form
Purification
Registration
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• 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
Completing the circle:
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