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Data Collection on the ProteinSimple Maurice: Driving Compliance with the Empower Control Kit

Presented by: Dayn Sommer, Ph.D. at WCBP 2020

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Data Collection on the ProteinSimple Maurice: Driving Compliance with the Empower Control Kit

  1. 1. Data Collection on the ProteinSimple Maurice: Driving Compliance with the Empower Control Kit Dayn Sommer, KBI Biopharma 28 Jan 2020 WCBP 2020
  2. 2. KBI Biopharma Overview ProteinSimple Maurice Empower® Control Kit Example Data
  3. 3. CONFIDENTIAL | 4 Analytical Services All Sites MORE HIGHLIGHTS Industry leading array of analytical equipment and scientific expertise 150+ Formulation development projects to date Multiple dosage forms: Intravenous, Subcutaneous, Intramuscular Intravitreal, Topicals Product concentrations ranging from 10 µg/mL to 300 mg/mL 200+ active product stability studies (GMP & non-GMP) KBI Is The Industry-Leader In Protein Analytics 3000+ Projects Completed 15 years Of Leadership in Formulation Development PERFORMANCE Experience Across all Biologics • IgG1 • IgG2 • IgG4 • Bispecific • IgM • Fab • ADC • Fc and other Fusion Proteins • Enzymes • Cytokines • Growth factors • Highly Glycosylated Proteins • Protein vaccines • PEGylated proteins • Conjugates • Peptides • Polyclonals • Biosimilars
  4. 4. CONFIDENTIAL | 5 COLORADO BOULDER, CO Microbial LOUISVILLE, CO Analytics Strain Development Process & Analytical Development cGMP Manufacturing and QC Services Analytical, Formulation, Stability Particle Characterization Core Modeling and Simulation Analytical Technologies Leading Biophysical Characterization NORTH CAROLINA DURHAM, NC Mammalian RTP, NC Mammalian Clinical & Commercial cGMP Manufacturing Analytical, Formulation, Stability & QC Mass Spec Core Facility Cell Line Dev- Offering SureTechnology Process & Analytical Development Process Characterization Small scale Process Validation TEXAS WOODLANDS, TX Cell Therapy Process and Analytical Development cGMP Manufacturing & Testing Cell Based Assays CALIFORNIA SAN DIEGO, CA Analytics Analytical Technologies Leading AUC expertise EUROPE GENEVA, SWITZERLAND KBI-affiliate Selexis LEUVEN, BELGIUM Analytics Best in class cell line development & variant screening technologies Analytical, Formulation and QC services for GMP & non-GMP product testing
  5. 5. CONFIDENTIAL | 6 Quality & Regulatory All Sites Successfully Completed 4 FDA Inspections No 483 observations. Includes two pre-approval inspections. Successfully Completed COFEPRIS Inspection North Carolina Site PERFORMANCE 15 years of pressure-tested quality systems & rigorous regulatory compliance. Global cGMP quality system supporting clinical and commercial biologics Manufactured and released hundreds of cGMP product lots Successfully Completed 2 EMA Inspections Boulder Site Supports 2 Commercial Products Analytical Testing Successfully Completed 2 FDA PAIs Successfully Completed EMA Inspection Product Approved in US and EU in 2018
  6. 6. CONFIDENTIAL | 7 Meet Maurice
  7. 7. CONFIDENTIAL | 8 Maurice –”moreiCE” 2016 CE – SDS, Native Fluorescence, On-board Mixing, Proprietary cartridges, …….
  8. 8. CONFIDENTIAL | 9 Maurice cIEF Cartridge
  9. 9. CONFIDENTIAL | 10 Maurice CE-SDS Cartridge
  10. 10. CONFIDENTIAL | 11 Consistency in Structure Across Assays cIEF CE-SDS the Cartridge determines the run modus: cIEF or CE-SDS
  11. 11. Compass by ProteinSimple Empower® 3 by Waters™ • Out-of-the-box software package for data acquisition through processing. • Fully 21 CFR Part 11 compliant: • Audit trail, system validations, and controlled access. • Transfer of data from Compass must be governed by internal procedures, including securing paths/locations • Export of data can result in loss of metadata • Enterprise software package for data acquisition, analysis, and storage. • Automated data analysis can be enabled to simplify QC testing. • Well-established in industry: • Validated in most companies • Extensive knowledge base and training solutions • Reduced software maintenance (IT, metrology) and streamlined data review
  12. 12. CONFIDENTIAL | 13 Sample plate layout (48 vial or 96-well plate) Create Method Input sample ID, location, and method Temperature Control cIEF Reagents Tabs
  13. 13. CONFIDENTIAL | 14 Peaks pane shows calculated results. Compass for iCE names automatically with user-defined peak name settings are color-coded pI markers Samples Single/ Total Sample View Peak Profiles Injection info E-gram options Injections tab provides peak area analysis pI marker pI marker
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  22. 22. CONFIDENTIAL | 23 Autosampler temperature can be modified Cartridge information displayed
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  27. 27. CONFIDENTIAL | 28 icIEF – pI Marker Calibration (Linear Regression) • The Empower® software will calibrate pI based on detection of pI marker position settings. • This calibration cannot be reperformed once data is collected. • Solutions • Adjust pI marker position and window size • Perform test injection of reference standard to determine pI marker pixel position • Excel • Create custom fields in empower to calculate pI values
  28. 28. CONFIDENTIAL | 29 • Component editor to assign values for designated pI markers • Integrate and identify component markers
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  30. 30. CONFIDENTIAL | 31 • Calculate pI of unknowns with custom fields
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  33. 33. CONFIDENTIAL | 34 CE-SDS – Corrected Area • Results are not only a function of concentration but also of analyte velocity through the detection window. Peak areas need to be normalized based on velocity. • Create corrected area calculations in empower to account for differences in apparent velocities between solutes:
  34. 34. CONFIDENTIAL | 35 CE-SDS – Corrected Area • Results are not only a function of concentration but also of analyte velocity through the detection window. Peak areas need to be normalized based on velocity. • Create corrected area calculations in empower to account for differences in apparent velocities between solutes: CE-SDS – MW Sizing • Empower will not determine sizing data automatically • Use custom fields to extrapolate sizing data if necessary
  35. 35. CONFIDENTIAL | 36 • Maurice is an efficient tool to analyze charge heterogeneity, determine pI, purity, and size of biomolecules • Updates from Protein Simple have allowed Maurice analysis with Empower® Software
  36. 36. CONFIDENTIAL | 37 • Maurice is an efficient tool to analyze charge heterogeneity, determine pI, purity, and size of biomolecules • Updates from Protein Simple have allowed Maurice analysis with Empower® Software • Maurice Empower® Control Software has been released!
  37. 37. CONFIDENTIAL | 38 Protein Simple Jessica Dermody Rick Le Bold Xin Jiang KBI Biopharma Charlie Abadie Christopher Cox Nathan Cox Michael Alloway Ben Pridgen
  38. 38. Dayn Sommer dsommer@kbibiopharma.comGuided by analytics, we help our partners develop and manufacture life-changing biologics. kbibiopharma.com @kbibiopharma

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