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Corporate Introduction Nov 2012

Corporate Introduction Nov 2012. Corporate Profile. Established 2006 Location Cambridge, Massachusetts USA Clients 125+ World Wide FDA Inspected 2010 QP Inspected 2011

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Corporate Introduction Nov 2012

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  1. Corporate Introduction Nov 2012

  2. Corporate Profile Established 2006 Location Cambridge, Massachusetts USA Clients 125+ World Wide FDA Inspected 2010 QP Inspected 2011 Blue Stream Laboratories is an advanced analytical CRO supporting the development of complex biologics and biopharmaceuticals through expertise in structural and functional characterization and formulation development programs, and the development of assays suitable for cGMP lot release and stability programs. Confidential

  3. Experienced Management Team • Mario DiPaola, Ph.D., MBA • Michael Kouchakdjian, Ph.D., MBA • Jim Stahl, Ph.D. • Elaine Stephens. Ph.D. • Chris Sucato, Ph.D. • David Zullo • William C. Rash • CSO / COO • President • Laboratory Director • Assoc Dir Protein Sciences • Head of Biophysical Lab • Head of QA • VP Sales and Marketing Confidential

  4. Biopharmaceutical Focus • Recombinant Glycoproteins / Proteins • Small Molecule Analytes / Residuals • Peptide Therapeutics / Vaccines • 82% (~ 40% mAb) • 10% • 8% Confidential

  5. International Client Base = BSL Business Confidential

  6. Diverse Client Base • Large Pharma / Biotech • Mid-size Biotech • Small / Virtual Biotech • Other • 37% • 22% • 36% • 5% Blue Stream Laboratories, 2012

  7. Product Development Support Method Development, Qualification Pre-IND Characterization, Screening Formulation Development Clinical cGMP Stability Biosimilar Comparability, Characterization Clinical cGMP Lot Release Commercial Testing Reference Standard Characterization ICH Method Validation IND BLA Product Development Confidential

  8. cGMP / ICH Regulatory Compliance IND Clinical Phase 1 - 3 BLA cGMP Testing since Q1 2007 cGMP Quality Assurance Department On-Site Documentation Support – all stages of product development FDA Regulatory Filing Support Successful US and European Quality Audit History Confidential

  9. Pre-IND Analytical Support Confidential

  10. Clinical Stage Analytical Support Confidential

  11. ICH / GMP Stability Program Management Formulation Dev., TOX, and cGMP Stability Programs Accelerated and Long-Term Chambers from -70°C to 45°C / Humidity Controlled Chambers available for custom and accelerated temperature and conditions Back-up Power All units and supporting systems qualified / validated Alarmed, Continuous Monitoring System Sample Tracking from Receipt → Disposition Performing cGMP Stability Programs since 2007 Comprehensive Structural and Functional Assay Support Confidential

  12. Stability Program Support… Physiochemical Specialty IsoQuant Deamidation Endotoxin (safety) USP Particulates (subcontracted) Sterility / Bioburden (subcontracted) • Abs280nm • Osmolality • Moisture Karl Fischer • pH • Solubility • Reconstitution Time • Appearance

  13. Technical Excellence Identity/ Purity Assays Functional Assays ELISA / Immunoassay SPR Biacore, BiOptix Colorimetric Others – Client Specific • Peptide Mapping • LC/MS, LC/MS/MS • HPLC Methods • RP, IEX, WCX, NP, HIC, etc.. • SEC HPLC • SDS PAGE / SDS - CE • IEF / cIEF • AUC • DLS, SEC-MALLS • Circular Dichroism

  14. Select Expertise Glycosylation Characterization Both N and O Linked Quantitative Analysis Three (3) Forms Enhanced Comparability • LC/MS/MS Glycosylation Mapping • Glycosylation Profile (HPLC + MS/MS) • Site Occupancy Percent Mapping • Glycan Structural Analysis LC/MS/MS • Sialic Acid Analysis • Monosaccharide Analysis • Biosimilar Program Support • Manufacture / Process Monitoring • Cell-Line Expression Evaluation • Media Optimization Screening

  15. Select Expertise Biophysical Characterization BiOptix and Biacore • Analytical Ultracentrifugation (AUC) • Circular Dichroism (CD) • Differential Scanning Calorimetry (DSC) • SEC-MALLS • Fourier Transform Infra-Red (FTIR) • Dynamic Light Scattering (DLS) • Surface Plasmon Resonance

  16. Select Expertise N-Terminal Sequencing • Impurity Identification (SDS PAGE–resolved or other) • Drug Substance (Lot Release ) ID • Identification of N-terminal clips not identified via peptide mapping • De novo sequencing (paired with LC/MS/MS peptide mapping) • BSL can deblock pyroglu (Mab HC) and other chemistries

  17. Attention to Client Service • Client Service • Speed • Communication • Responsiveness • Flexibility • Reliability • Formal Project & Alliance Management Function

  18. www.BlueStreamLabs.com

  19. ICH / GMP Stability Program Management Formulation Dev., TOX, and cGMP Stability Programs Accelerated and Long-Term Chambers from -70°C to 45°C / Humidity Controlled Chambers available for custom and accelerated temperature and conditions Back-up Power All units and supporting systems qualified / validated Alarmed, Continuous Monitoring System Sample Tracking from Receipt → Disposition Performing cGMP Stability Programs since 2007 Comprehensive Structural and Functional Assay Support Confidential

  20. Stability Program Support… Physiochemical Specialty IsoQuant Deamidation Endotoxin (safety) USP Particulates (subcontracted) Sterility / Bioburden (subcontracted) • Abs280nm • Osmolality • Moisture Karl Fischer • pH • Solubility • Reconstitution Time • Appearance

  21. Sample BSL Timelines Investigation into behavior of molecule under various conditions: add’l Formulation Dev and Process Changes also investigated (wks) 4 3 wks 28 21wks 6 wks 8 12 9 wks 16 12 wks 15 wks 20 24 18 wks 24 wks 32 Method Qual for cGMP Stability and Lot Release: ALL METHODS Method Qual or ICH Validation for cGMP: ALL METHODS Tech Trans and Optimization: RPHPLC, SEC, CEX, Peptide Map, HCP Tech Transfer and Optimization RP HPLC, SEC, CEX, Pep Map Method Development ELISA and LC/MS/MS or alternative Method Development ELISA, LC/MS/MS or Alt. Method Development ELISA, SDS PAGE, Lot Release and Stability programs Characterization: Detailed Mapping, AUC, DSC, ITF, Ext Coef., N-Term, etc Characterization: Detailed Mapping, AUC, DSC, ITF, Ext Coefficient, N-Term Screening / Analysis of Process Samples and Process Residuals Testing Confidential

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