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Valitacell Technology
- 2. • Molecular diversity of new protein products • Speed in cell line engineering and development • Control of product quality and molecular heterogeneity Key Challenges In Upstream Process Development
- 3. Valitacell™ Vision Valitacell™ develops technologies that improve cell performance, which enables cell based products to be made faster and cheaper, with greater regulatory confidence
- 4. Oct 2016 Product Family Development Pipeline Feb 2016 ChemStress:Fluorescence Polarisation: Product Launch
- 5. 1 Plate coated with fluorescently labeled IgG binding peptide 3 Sample is added Fluorescence Polarisation Valita™TITER Mechanism 2 IgG binding peptide becomes resuspended in buffer 4 IgG measured on an FP reader
- 7. Speed • A 96-well plate can be read on a plate reader in 2.5 minutes • Valita™APP software is readily integrated to existing data management systems • Fully automatable Valita™TITER Speed & Throughput 2.5′ =′
- 8. Valita™TITER Simplicity • Easy to use • No complex sample preparation steps • Low sample volume
- 9. Valita™TITER Precision, Dynamic Range & Sensitivity 0.5 - 6 mg/L 2.5 - 80 mg/L • Assay CV < 2% • Wide dynamic range of IgG measurement
- 10. Valita™TITER Selectivity IgG Class IgG (1-4) ✔ Human κ ✔ Human λ ✔ Bispecific ✔ IgG fusion ✔
- 11. Valita™TITER Protein A HPLC / Octet® Comparison
- 12. Valita™TITER Protein A HPLC / HTRF Comparison ProteinAHPLC (relative units)
- 13. Summary Fluorescence Polarisation Valita™TITER Octet® Gyros™ HTRF Protein A HPLC Simplicity +++ ++ ++ ++ + Speed +++ + ++ ++ + Consumable cost +++ ++ + ++ + Capital Cost +++ + + ++ + Sample Volume ++ ++ +++ ++ ++ Sensitivity ++ ++ +++ ++ +++ Throughput +++ ++ + ++ + Selectivity +++ +++ +++ ++ +++
- 14. Problem Statement The assessment of functional biological variation associated with core complex components of the cellular manufacturing system takes time and money
- 15. Toxic Catabolites Oxidative Stress Nutrient Starvation pH and Osmolarity • A 96-well plate coated with numerous small molecule chemicals • Engineered to rapidly profile a cell’s response to diverse environmental stresses in terms of growth and productivity • Chemical selection from > 1000’s chemicals derived from extensive bioinformatic analyses • Tested in CHO cells at optimal concentration ChemStress Concept
- 16. ChemStress Concept e.g. Brefeldin A • Lactone antibiotic • Inhibits protein transport Toxic Catabolites Oxidative Stress Nutrient Starvation pH and Osmolarity
- 17. ChemStress Fingerprint ChemStress Fingerprint Chemical Cell Stressors RelativeGrowth Response RelativeTiter Response Chemical Cell Stressors 3 DAYS
- 18. Product Launch Market ChemStress Product Family Development Pipeline Development ChemStress:
- 19. Confirmation Of Clonal Identity
- 20. Cell Line B Cell Line A Cell Line C Cell Line D etc. Internal Cell Bank ChemStress Clone Identification - Model Development Cell Database ChemStress Fingerprints Proprietary Algorithms
- 21. Best Match! Cell Line: B Probability: 0.98 Query Cell Line Generate a ChemStress Fingerprint ChemStress Clone Identification - Application ? Submit Query Fingerprint to Cell Database 3 DAYS
- 22. The ChemStress fingerprint can: • Uniquely identify cell lines with resolution down to the clonal level • Reliably discriminate & indicate instability when a clone becomes non-self • Enable rapid traceability • Provide quality assurance ChemStress Clone Identification
- 24. Media Lot Testing Pathway of Current Methods Media Manufacturing Lot A Lot B Lot C Lot D ACCEPT LOT ACCEPT LOT ACCEPT LOT ACCEPT LOT Reference Lot ✓ ✓ ✓ ✓ 3 WEEKS COA Fed-batch REFERENCE
- 25. ChemStress Media Lot QC Testing Using ChemStress Fingerprint Reference Cell Line ChemStress Fingerprints Company Determined Δ vs. Ref. Lot Proprietary Algorithms ACCEPT LOT REJECT LOT REJECT LOT ✓ ✕ REJECT LOT ✕ ✕ 3 DAYS Lot A Lot B Lot C Lot D Ref. lot
- 26. ChemStress Media Lot Responses to Individual Chemical Stressors Lot D REF Lot A Lot C Lot B REF Lot A Lot B Lot C Lot D REF Lot A Lot C Lot D Lot B Menadione Sodium Bisulfite Cobalt Chloride Sodium Lactate RawGrowth RawGrowth RawGrowth
- 27. ChemStress – Local application Sensitivity Dependent on Cell Line Cell Line 1 Cell Line 2 Chemicals Chemicals
- 28. Early Stage Clone Selection
- 29. ChemStress Current Clone Selection Practice Transfection Parentals Daughters Fed- batch/Ambr Stability In process Banking & Bioreactor 6-12 months
- 30. ChemStress Early Stage Clone Prediction – Model Development 2016 Clone qP Proprietary Algorithms Clone qP Clone qP Ranking with 85% Probability Model Training Transfection Parentals Daughters Fed- batch/Ambr Stability Banking & Bioreactor In process
- 31. ChemStress Early Stage Clone Prediction – Model Development 2017 Clone HCP Proprietary Algorithms Clone HCP Clone HCP Transfection Parentals Daughters Fed- batch/Ambr Stability Banking & Bioreactor In process Model Training
- 32. Clone HCP, Glycosylation Clone HCP, Glycosylation Clone HCP, Glycosylation Transfection Parentals Daughters Fed- batch/Ambr Stability In process Banking & Bioreactor ChemStress Early Stage Clone Prediction – Model Development 2018 Model Training
- 33. ChemStress Early Stage Clone Prediction – Development? Critical Quality Attributes Critical Quality Attributes Critical Quality Attributes Transfection Parentals Daughters Fed- batch/Ambr Stability In process Banking & Bioreactor Model Training
- 34. Prediction of Clonal Stability
- 35. Clone B Clone A Clone C UNSTABLE STABLE STABLE Multigenerational subcloning with spot IgG assays – Δ IgG determined by company 60 – 100 Generations [60 – 100 Days] ✓ ✕ ✓ StabilityFed- batch/Ambr In process Banking & Bioreactor Stability Testing Current
- 36. ChemStress Stability Testing – Model Development Clone Δ IgG Clone Δ IgG Clone Δ IgG Δ Δ Δ UNSTABLE STABLE STABLE✓ ✕ ✓ Model Training StabilityFed- batch/Ambr In process Banking & Bioreactor
- 37. Stability Testing Current vs. ChemStress Clone B Clone A Clone C Clone B Clone A Clone C UNSTABLE STABLE STABLE Multigeneration subcloning with spot IgG assays – Δ IgG determined by company. 60 – 100 Generations [60 – 100 Days] Gen A Gen B ✓ ✕ ✓ UNSTABLE STABLE STABLE ✓ ✕ ✓
- 39. Summary Valitacell™ Product Pipeline Product LaunchDevelopment Market
- 40. Get a Valitacell™ demo in Your Lab: Email: info@valitacell.com Web: www.valitacell.com
Editor's Notes
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- Concentration is measured by detection of binding of the igg binding peptide. This is achieved though measurement of molecule size via detection of changes in light polarisation caused by their rotation. Binding can be detected as Small, unbound molecules rotate rapidly in solution, and large, IgG bound molecules rotate slowly.
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