Hypothermic Storage Media Products     For Cells, Tissues, and Organs          Optimizing Biopreservation Economics       ...
FORWARD LOOKING STATEMENT DISCLOSUREThis presentation contains forward-looking statements within the meaning of the Privat...
We strive to be the leading provider of biopreservation tools for cells, tissues, and organs;      to facilitate basic and...
We are committed to manufacturing products in accordance with            applicable current Good Manufacturing Practices a...
PRODUCTS  SERVICES•     Products:      •    Proprietary, cGMP, serum-free, protein-free biopreservation           media pr...
REGENERATIVE MEDICINE OVERVIEW•     Regenerative Medicine is the process of engineering      living, functional cell and t...
REGENERATIVE MEDICINE OVERVIEW                                                                                      #)-03
%%)
-/ -*4/$ ;@ •    Market activity1:     •         900 active clinical trials for new therapies                         @FH ...
% ;@
growth rate     •         Increasing quality and regulatory pressure to move                   @HCC               away fro...
BIOPRESERVATION WORKFLOW Enabling end to end biopreservation workflow optimization with newly integrated solutions; from s...
%%)                              )9+-*.. ./*-%)#                                  /*-# )      ,2%.%0*) )                  ...
!$         Pre-filled biologic        packaging products               BioLife biopreservation                            ...
ISSUES WITH HOME-BREW BIOPRESERVATION MEDIA•     Internally formulated biopreservation media products:      •    Based on ...
+-*..                                                         ( #                                                         ...
BIOLIFE RESEARCH DISCOVERIES•     Preservation induced cell damage and death       •   Metabolic activity decreases       ...
BIOPRESERVATION ECONOMICS                                                      % : *./ 5)(%•   Overall system performance ...
IMPACT OF LIMITED SHELF LIFE                   !  12 OTCBB: BLFS
$
FORMULATION INNOVATION•   Intracellular-like media:     •   Ionic concentrations are tuned to balance the intracellular st...
PROPRIETARY PRODUCTS   HypoThermosol®                                CryoStor®   Storage  Shipping Media                  ...
PRODUCT VALUE PROPOSITION                         99
)9 *2. *-(20*)                               -5*/*-         5+*$-(*.*                                                     ...
8-2(8
%( ( (
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Comparison of Hypothermic Storage Media

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An overview of cell/tissue hypothermic storage media formulations and the HypoThermosol technology platform

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Comparison of Hypothermic Storage Media

  1. 1. Hypothermic Storage Media Products For Cells, Tissues, and Organs Optimizing Biopreservation Economics from Source Material to Finished ProductAugust 2010 © 2010 BioLife Solutions, Inc.
  2. 2. FORWARD LOOKING STATEMENT DISCLOSUREThis presentation contains forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995 including, but not limited to, statements aboutBioLife Solutions, Inc. (the “Company”) and its future operating results, strategies, andproduct development plans. These forward-looking statements are based on currentexpectations and assumptions that are subject to risks and uncertainties. Actual resultscould differ materially from the results expressed or implied in these forward-lookingstatements. Factors that may cause or contribute to such differences are more fullydiscussed, as are other factors, in Part I, Item1A. “Risk Factors” of the Company’s Form10-K for the fiscal year ended December 31, 2009, which is on file with the SEC andavailable at www.EDGAR.com. In addition, any forward-looking statements represent ourestimates only as of today and should not be relied upon as representing our estimates asof any subsequent date. While the Company may elect to update forward-lookingstatements at some point in the future, the Company specifically disclaims any obligationto do so except as may be legally necessary, even if the Company’s estimates shouldchange.2 OTCBB: BLFS 2
  3. 3. We strive to be the leading provider of biopreservation tools for cells, tissues, and organs; to facilitate basic and applied research and commercialization of new therapies by maintaining the health and function of biologic source material and finished products during the preservation process.3 OTCBB: BLFS
  4. 4. We are committed to manufacturing products in accordance with applicable current Good Manufacturing Practices and Quality System Regulations. Every team member in the organization is responsible for ensuring product quality during the performance of their duties and identifying opportunities for continuous quality improvement. We Will: • Provide products and services of the highest possible standards to satisfy our customer needs and expectations of quality, safety, reliability and performance • Encourage and promote a corporate culture of continuous quality improvement • Maintain effective Quality Assurance Systems • Invest to enhance the skills of all team members4 OTCBB: BLFS
  5. 5. PRODUCTS SERVICES• Products: • Proprietary, cGMP, serum-free, protein-free biopreservation media products for cells, tissues, and organs: • HypoThermosol® hypothermic storage shipping media • CryoStor® freeze media • BloodStor™ generic, cGMP cord blood stem cell freeze media• Services: • Custom biopreservation media formulation, fill, and finish into standard and custom packages • Customers include several competitors and the US Army • Contracted R D to optimize biopreservation outcomes • Biopreservation media formula development • Verification of cell specific freezing/thawing rates and protocols 5 OTCBB: BLFS 5
  6. 6. REGENERATIVE MEDICINE OVERVIEW• Regenerative Medicine is the process of engineering living, functional cell and tissue-based therapies and administering these to patients to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects• Target diseases include cancers, diabetes, heart disease, ALS• Target disorders include spinal/movement, hearing loss, vision loss, neurological (i.e., stroke)• Nearly all currently available and development stage regenerative medicine products and therapies utilize biopreservation processes in the acquisition of source material, isolation and manipulation of specific cells, and storage and shipment of a final product dose to a patient location• Biopreservation economics greatly impact product commercialization potential • (system costs of the shelf life functional yield environment) 6 OTCBB: BLFS 6
  7. 7. REGENERATIVE MEDICINE OVERVIEW #)-03
  8. 8. %%)
  9. 9. -/ -*4/$ ;@ • Market activity1: • 900 active clinical trials for new therapies @FH @FC • 687 companies worldwide @EH @EC• Market size and growth estimates2: @DH @DC • Market could reach $32B by 2018 @H @C• Demand for biopreservation media3 used in * CCK E + ECDJ process development, manufacturing, and commercial product storage, transport, and freezing will mirror the end product market () *- %*+-.-30*)
  10. 10. % ;@
  11. 11. growth rate • Increasing quality and regulatory pressure to move @HCC away from internally formulated ‘home-brew’ media @GCC @FCC and reagents @ECC • Limited risk of disruptive, competitive, @DCC technologies; BioLife products are the next @C ECCK * +ECDJ disruptive technology that will capture share • Previous 9 nine quarters: BioLife product shipments to 200+ accounts 1Proteus Venture Partners, 2MedMarket Diligence, LLC, 3Management estimates 7 OTCBB: BLFS 7
  12. 12. BIOPRESERVATION WORKFLOW Enabling end to end biopreservation workflow optimization with newly integrated solutions; from source material to final product! %*+-.-30*) *-*4 %) #)-03
  13. 13. %%) )9+-*.. ./*-%)# /*-# ) ,2%.%0*) ) *- -6%)# 2/2-%)# 2+ /* .$%+()/ * )/-).+*-/0*) * .*2- %.*/ *- %)% *. +-*2/ *. (/-% ()%+2/ . /* +0)/ ! !! ) $
  14. 14. !$ Pre-filled biologic packaging products BioLife biopreservation media products from partners 8 OTCBB: BLFS 8
  15. 15. ISSUES WITH HOME-BREW BIOPRESERVATION MEDIA• Internally formulated biopreservation media products: • Based on historical, non-optimized formulas • Made daily/weekly and subject to lot-lot variability • Often not made with USP grade components • Often not made under current GMP • Subjected to less stringent (non-lot specific) release testing for sterility, endotoxin, mycoplasma, etc. *)9
  16. 16. +-*.. ( # **-- ,2%/5 %./*-% *-(20*) )!%)/ 4*-*4 %(%/ +-.-30*) %)% /. /$ 3-%%%/5 *4 .%%/5 */ *+0(%6 *- ./ +-0. %(%/ -. /.0)# = #- *(+*))/. 9 OTCBB: BLFS 9
  17. 17. BIOLIFE RESEARCH DISCOVERIES• Preservation induced cell damage and death • Metabolic activity decreases • Ionic and osmotic balances are disrupted • Free radicals accumulate • Molecular stress responses are initiated• Two injury mechanisms • Necrosis – mechanical destruction of cell membrane • Apoptosis – enzyme based, programmed cell death• Two injury exposure periods • During hypothermic storage and freezing • During re-warming/thawing• Delayed preservation induced cell injury – not apparent or appreciated • Immediate post-thaw assays do not accurately indicate cell viability • Perceived Viability True Viability• Traditional preservation media formulations do not adequately protect cells from preservation induced stress• Innovation opportunities to re-formulate preservation media to mitigate underlying causes of preservation related cell damage and death 10 OTCBB: BLFS
  18. 18. BIOPRESERVATION ECONOMICS % : *./ 5)(%• Overall system performance is constrained by limited stability, yield loss, and processing costs )• Incremental and cumulative optimization of biopreservation % processes can maximize the yield- cost relationship• System optimization should strive to move up and to the left 5./( *./ % 11 OTCBB: BLFS
  19. 19. IMPACT OF LIMITED SHELF LIFE ! 12 OTCBB: BLFS
  20. 20. $
  21. 21. FORMULATION INNOVATION• Intracellular-like media: • Ionic concentrations are tuned to balance the intracellular state at low temperature to reduce gradient formation and water flux• pH buffering capacity: • Organic and inorganic buffers include bicarbonate and HEPES • Effective from 15°C to 2°C• Free radical scavengers• Osmotic stabilizing components • To reduce and control shrinking and swelling of cells during preservation process temperature changes• Serum-free energy substrates• Pre-formulated with cryoprotective agents (2%, 5%, or 10% DMSO) • No user mixing required• Fully-defined components • USP/multi-compendial or highest available grade13 OTCBB: BLFS
  22. 22. PROPRIETARY PRODUCTS HypoThermosol® CryoStor® Storage Shipping Media Freeze Media Formulary improvements to organ Based on HypoThermosol formula preservation media For cryopreservation of biologics at Serum-free and protein-free - 80°C to -196°C For 2 - 8°C short term storage and Pre-formulated with 2%, 5%, or 10% shipment of biologics DMSO Enables functional restart upon return Serum-free and protein-free to normothermic temperature Outperforms other commercial Extends stability of specimens, products and home-brew freeze pancreata, liver sections, tumor cocktails biopsies, tissue samples, bone marrow14 OTCBB: BLFS
  23. 23. PRODUCT VALUE PROPOSITION 99
  24. 24. )9 *2. *-(20*) -5*/*- 5+*$-(*.* ;
  25. 25. 8-2(8
  26. 26. %( ( (
  27. 27. $ $ # ) ( 15 OTCBB: BLFS
  28. 28. REGULATORY STATUS• Preservation solutions are not devices or drugs; considered excipient orancillary material in clinical applications • Ancillary material: used in manufacturing cell, gene, or tissue-engineered products, but not intended to be in final product (washed or removed) • Excipient: component intended to be part of the final product at clinical application• We help customers comply with Good Tissue Practices (GTP – 1271.210) • Highest quality reagents must be utilized in the process of developing Human Cellular, Tissue, and Tissue-Based Products (HCT/Ps) • “all reagents must be verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of the introduction, transmission, or spread of communicable diseases”• Type II FDA Master Files regularly updated for both HypoThermosol® and CryoStor® product platforms 16 OTCBB: BLFS 16
  29. 29. QUALITY SYSTEMS• Certified to: • ISO 13485:2003 medical device quality systems management• Adherence to: • 21 CFR part 820 Quality Systems Regulation of Good Manufacturing Practices for medical devices (GMP) • 21 CFR parts 210 and 211 covering GMP for Aseptic Production • ISO 13408 manufacturing processes for aseptically-processed health care products • Volume 4, EU GMP Guidelines, Annex 1: Manufacture of Sterile Medicinal Products • ISO 14644 Clean Rooms and Associated Controlled Environments• Product Release Criteria: • Sterility Tested USP 71 • Endotoxin Tested USP 85 • Cell based preservation efficacy assay • pH • Appearance 17 OTCBB: BLFS 17
  30. 30. PRODUCT ADOPTION• Our biopreservation media products are incorporatedinto numerous development stage and commercialbiologic products • cellular therapies • umbilical cord blood units • cells and cell lines used in drug screening• Critical supplier status with leading regenerativemedicine and life science tools companies 18 OTCBB: BLFS 18
  31. 31. EXTENDED SHELF LIFE 5 Day Hypothermic Storage of Human Dermal Fibroblasts Enabled by HypoThermosol® - Assayed 24 Hours Post Storage 125 100% Recovery of Viable Cells 75 50 25 0 Plasma-Lyte Viaspan Plasma-Lyte Viaspan Plasma-Lyte Viaspan HypoThermosol-FRS FGM (Media)* Normosol-R Celsior HypoThermosol-FRS FGM (Media)* Normosol-R Celsior HypoThermosol-FRS FGM (Media)* Normosol-R Celsior AQIX AQIX AQIX 1 Day Storage 3 Day Storage 5 Day Storage 19 alamarBlue® stain for metabolic activity * Contains serum 19
  32. 32. EXTENDED SHELF LIFE Representative Fluorescent Micrographs Illustrating Morphology of Normal Human Dermal Fibroblasts Stored in HypoThermosol®
  33. 33. % 4%/$ -2( .%*- %.+) 5+*$-(*.*F 5 /*-#H 5 /*-# GC (#)% 0*) ! 0) 5/*./*)
  34. 34. %/*$*)-% 030*) 2- /%) 20 $*%%) ;
  35. 35. %/*-- *$./ 20
  36. 36. % Recovery of Viable Cells 21 0 20 40 60 80 100 HypoThermosol-FRS MSCGM (Media) * Normosol-R Plasma-Lyte AQIX 1 Day Storage Celsior Viaspan HypoThermosol-FRS MSCGM (Media) * alamarBlue® stain for metabolic activity Normosol-R Plasma-Lyte AQIX 3 Day Storage Celsior Viaspan HypoThermosol-FRS MSCGM (Media) * * Contains serum Normosol-R Plasma-Lyte AQIX 5 Day Storage Celsior HypoThermosol® - Assayed 24 Hours Post Storage Viaspan HypoThermosol-FRS MSCGM (Media) * Normosol-R Extended Hypothermic Storage of Human Mesenchymal Stem Cells Enabled by Plasma-Lyte AQIX 7 Day Storage21 Celsior Viaspan EXTENDED SHELF LIFE
  37. 37. EXTENDED SHELF LIFE Representative Fluorescent Micrographs Illustrating Morphology of Human Mesenchymal Stem Cells Stored in HypoThermosol® *-(*.*9 .(95/ %.+) 5+*$-(*.*D 5 /*-#F 5 /*-# EC (#)% 0*) ! 0) 5/*./*)
  38. 38. %/*$*)-% 030*) 2- /%) 22 $*%%) ;
  39. 39. %/*-- *$./ 22
  40. 40. EXTENDED SHELF LIFE Recovery of Human Osteoblast Cells Following Hypothermic Storage Assayed 24 Hours Post Storage - Differentiated Following 5 Day Hypothermic Storage of Undifferentiated hMSC in HypoThermosol 125 100% Recovery of Viable Cells 75 50 25 0 Plasma-Lyte Viaspan Plasma-Lyte Viaspan Plasma-Lyte Viaspan HypoThermosol-FRS Media * Normosol-R Celsior HypoThermosol-FRS Media * Normosol-R Celsior HypoThermosol-FRS Media * Normosol-R Celsior 1 Day Storage 3 Day Storage 6 Day Storage 23 alamarBlue® stain for metabolic activity * Contains serum 23
  41. 41. POST-PRESERVATION DIFFERENTIATION CAPACITY Representative Fluorescent Micrographs Illustrating Morphology of Human Osteoblast Cells Following Hypothermic Storage - Differentiated Following 5 Day Hypothermic Storage of Undifferentiated hMSC in HypoThermosol *-(*.*9 .(95/ %.+) 5+*$-(*.*F 5 /*-#I 5 /*-# EC (#)% 0*) ! 0) 5/*./*)
  42. 42. %/*$*)-% 030*) 2- /%) 24 $*%%) ;
  43. 43. %/*-- *$./ 24
  44. 44. EXTENDED SHELF LIFE 24 Hour Post Storage Recovery of Human Dental Pulp Stem Cells Following Hypothermic Storage Commercial Solution Comparison: Serum and Serum-Free Media 125 100% Recovery of Viable Cells 75 50 25 0 Plasma-Lyte Viaspan Plasma-Lyte Viaspan Plasma-Lyte Viaspan HypoThermosol-FRS RPMI (Media) * Normosol-R Celsior HypoThermosol-FRS RPMI (Media) * Normosol-R Celsior HypoThermosol-FRS RPMI (Media) * Normosol-R Celsior 1 Day Storage 3 Day Storage 5 Day Storage 25 alamarBlue® stain for metabolic activity * Contains serum 25
  45. 45. TECHNOLOGY SUMMARY• Scientific validation across a broad set of biologics, offering significantperformance and quality advantages• Proven ability to extend stability and improve post-preservation viability,recovery, and function of specimens, source material, and isolated cells• Viewed as a critical manufacturing reagent supplier by numerous celltherapy companies and cell suppliers• Demand for our proprietary products will closely follow pace ofincreased regulatory and quality oversight of reagents used in clinicalproduct development, processing, storage, transportation, and infusion 26 OTCBB: BLFS 26

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