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3 GPure Prepacked Clumns A high-perfrmance, flexible purificatin platfrm Rick Garretsn Business Develpment Manger 3

4 GPure Prepacked Clumns Delivering flexibility fr dwnstream prcessing Needs GPure Clumns ffer Faster prcess changever Reduce set up times by up t 80% Save Time: Faster time t prcess and reduced time between prcesses Flexible design: Multiple diameters, bed heights and resins, allwing prepacked clumns t be tailred t yur prcess Simplified scalability: Qualified, reprducible prepacked clumn simplifies prcess scale up r dwn Reduced capital expenditure Operating cst reductin Risk mitigatin Flexibility Quality Eliminates need t purchase and stre clumn hardware GPure clumns eliminate need t develp packing SOPs and equipment cleaning validatin Minimizes ptential fr prduct carryver r clumn packing failures Multiple clumn diameters, heights and resin types Packed in clean rm with semiautmated packing equipment and supprted by ISO 9001 and quality management standards 4

5 GPure Prepacked Clumns Prduct design Dimensins Diameter (cm) Length (cm) Clumn Vlume (ml) 1.2 5, 10, 15, 20 5, 11, 17, *, 10, 15, , 502, 754, *, 10, 15, , 3100, 4700, 6300 *POROS HQ nly Design Flexible bed heights available in 1 cm increments POROS and nn-poros resin packing capability Sanitary cnnectins n 8 and 20 cmd clumns. Standard NPT threaded cnnectin fr 1.2 cmd clumn Maximum Pressure: 6 Bar (Hardware nly) Hardware chemical resistance aligned with biprcess applicatins GPure 20 cm Clumn Assembly Drawing Packing Specificatins: Plates / Meter: POROS resin 4000; nn-poros resins meet r exceed vendr claims Asymmetry: Permeability: Resin dependent, measured at defined flw rate Clumn Test Certificate included 5

6 GPure Prepacked Clumns Time and cst savings Hurs The use f GPure 20 cm Clumn prvides significant time savings as cmpared t self-packing clumns 6

7 GPure Prepacked Clumns Services GPure Clumn Catalg Items Standard diameters and lengths packed with POROS Resins: -HS-50 -XS - MabCapture A - HQ-50 Many GPure 1.2cmD Clumns in stck GPure Clumn Packing Service Packing prcesses established fr numerus backbnes and surface chemistries; representative f mst cmpressible biprcess resin families Validated qualificatin methds; established specificatins Endtxin & biburden ptin Starting pint fr custmer specific part number Packing Study Optins fr New Resin Types Fee fr service mdel User defined specificatins 7

8 GPure Prepacked Clumns Capabilities Clumn packing peratins ISO 8 clean rm Rutine air and surface mnitring Prcess water prduced by RO/DI /UV kill system Mnitred fr TOC, endtxin resistivity and biburden Semi-autmated clumn packing skids Flex manufacturing team 7 skilled peratrs address demand surges 8 Fractgel Resin Qualificatin

9 GPure Prepacked Clumns Expertise Experience GPure Clumn packing peratins cmmenced in 2009 Mre than 550 clumns sld 46% grwth f nn-poros resins packed in GPure Clumns Resin families packed: POROS IEX Resins POROS Affinity Resins Fractgel Resin MabSelect SuRe Resin MabSelect Resin Typearl 650M Resin Sepharse High Perfrmance Sepharse Fast Flw Capt S Resin Capt Adhere Resin Prduct line grwth substantiates technical, manufacturing and quality system capability Percent Cntributin GPure Clumns packed with nn POROS Resins: Sales Cntributin 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Nn POROS 0% 6% 10% 28% 41% 9

10 GPure Clumn Packing Service Prcess Descriptin and Flw Step 1 Step 2 Step 3 Definitin f clumn requirements Qutatin Order prcessing Resin Receipt Clumn manufacturing QA release Defined prcess prvides High perfrmance clumns Custmer defined prduct Reliable turn arund times Resin traceability Supprted by ISO 9001 and quality management system 10

11 GPure Clumn Packing Service Qutatin prcess-input Infrmatin Required 1. Cntact infrmatin 2. Clumn details Clumn dimensins Resin manufacturer, resin name and part number Requirement fr pst-pack sanitizatin Requested delivery date Number f clumns Shipping and strage temperature Shipping slutin Requirement fr biburden/endtxin Other requirements 11

12 GPure Clumn Packing Service Qutatin prcess-utput Prpsal includes: Qutatin infrmatin Prduct number Prduct descriptin Price Delivery time Cver letter Clumn specificatins Other deliverables 12

13 GPure Clumn Packing Service Part numbers Part numbers define: Clumn hardware (resin independent) Strage cnditins AMB- Ambient REF- Refrigerated Testing requirements Standard clumn qualificatin Plates (N/m) HETP Pressure vs. Flw Qualificatin plus micrbilgical testing Endtxin Biburden Packing develpment study ptin 13

14 GPure Clumn Packing Service Internal traceability, Validated business prcess Qute number n shipping dcuments Unique resin identifier Upn receipt, resin is labeled and segregated Custmer name Qute number Wrk rder number Sales rder number (Internal LTC rder tracking) Resin details QC inspectin fr accuracy and release f resin t manufacturing Wrk rder Resin label Batch recrd 14 GPure Custm Clumn Prcess Flw QA MFG QC GSC Planning Receive SO & Qute Inf Resin Rcvd Verify: 1) Resin Name 2) Resin Manufacturer Name 3) Qute Number 4) Verify nly 1 lt received N QC inspects material fr cnfrmity t infrmatin in Batch Recrd, Labels & Wrk Order N Finite Schedule Wrk Order Data frm Qute: 1) Custmer Name 2) Resin Name 3) Resin Manufacturer Name Run MRP Planned Order 4) Qute Number Schedule WO 5) Sales Order Number 6) Clumn Length (Bed Height) 7) Resin amunt required 8) Sanitizatin y/n 9) Strage Sln 10) SOP # r Custm Instructins & PR # Yes Yes Obtain Line Clearance Pack Clumn(s) Label Resin Bttle(s) 1) Wrk Order Number 2) Custmer Name 3) Resin Name 4) Resin Manufacturer Name 5) Qute Number 6) Sales Order Number Generate RMQC Number Test Clumn(s) Print Test Cert Print Vendr CfA Label all Resin bttles with green RMQC # stickers Label & Package Clumn(s) Place Labeled Resin in designated Custm Resin strage lcatin Deliver Batch Recrd and Resin t MFG strage lcatin fr incming Custm Resins Clumn, BR Inspectin & Release Release Wrk Order Deliver Batch Recrd t incming QC inspectin bin Yes N Create Batch Recrd POROS Resin N Deliver t and Ntify GSC PR Quarantine Yes Package and Ship Clumn(s)

15 GPure Clumn Packing Service Labeling & Dcumentatin Clumn Label Resin Lt Vlume: 502 ml Resin Vendr COA Bx Label 15

16 GPure Prepacked Clumns Validatin package Bed Stability Ship testing per Internatinal Safe Transit Assciatin (ISTA) Strage stability Cycling study Clumn Sanitizatin and Strage Safety Anti-micrbial effectiveness testing USP Class VI testing AOF and FDA CFR 21 Part and cmpliance certificatin Burst pressure Dcumentatin Regulatry Supprt Package Clumns Test Certificate Chrmatgraphy Resin CA 16

17 GPure Prepacked Clumns Case Study: Packing f Multiple Resins and Clumn Scale-up Custmer required multiple clumns packed with: Agarse Prtein A resin, 20cmL Highly cmpressible CEX resin, 20 cml POROS HQ resin, 5 cml Applicatins Viral Clearance: GPure 1.2 cmd clumns Engineering Run: GPure 8.0 cmd clumns GMP Manufacturing: GPure 20 cmd clumns 17

18 GPure Prepacked Clumns mab Capture Clumn: Cmpressible Prtein A Asymmetry Asymmetry fr Prtein A in 20cmL Clumn Observatin Clumn qualificatin meet r exceed vendr specificatins Efficiency (Plates) cmd x cml 1.2X X20 20X20 Clumn Specificatins Asymmetry: Efficiency: 2000 Efficiency fr Prtein A in 20cmL Clumn Observatin cmd x cml 1.2X20 8X20 20X20 18

19 GPure Prepacked Clumns Plish Clumn: Highly Cmpressible SCX Asymmetry Asymmetry fr SCX in 20cmL Clumn Observatin Cnsistent results acrss all clumns Efficiency (Plates) cmd x cml 1.2X20 8X20 20X Clumn Specificatins Asymmetry: Efficiency: 3000 Efficiency fr SCX in 20cmL Clumn Observatin cmd x cml 1.2X20 8X20 20X20 19

20 GPure Prepacked Clumns Plish Clumn: Rigid POROS HQ Resin Asymmetry fr POROS HQ Resin in 5cmL Clumn Asymmetry Observatin cmd x cml 1.2X5 8X5 20X5 Clumn Specificatins Asymmetry: Efficiency: 4000 Efficiency fr POROS HQ Resin in 5cmL Clumn Qualificatin results exceed custmer specificatins Efficiency (Plates) Observatin cmd x cml 1.2X5 8X5 20X5 20

21 GPure Pre Packed Clumns Case Study: Prcess stability Custmer required multiple clumns packed with: Phenyl Agarse resin, 8 cmdx6cml Applicatins Prcess develpment: GPure 8.0 cmd clumns Engineering run: GPure 8.0 cmd clumns 21

22 GPure Prepacked Clumns Manufacturing Reprducibility High perfrmance, reprducible results ver multi lts and years A symmetry Efficiency Asymmetry Asymmetry by lt number: Phenyl Sepharse GPure 8X68cmD by LtNumber x 6 cml Clumns Observatin Observatin _ UCL=1.453 X=1.205 LC L=0.957 Efficiency Efficiency by lt number: Phenyl Sepharse GPure 8X6 8cmD by LtNumber x 6 cml Clumns 2010 Prductin 2011 Prductin 2012 prductin UC L=19151 _ X=12086 LC L=

23 GPure Prepacked Clumns Cnvenient and flexible Time Savings Setup time reduced by up t 80% with ready-t cnnect clumns Avids cst f hardware purchase, clumn packing develpment and cleaning validatin Flexibility Multiple clumn diameters and lengths POROS and nn-poros resins High Perfrmance Prepacked Clumns Standardized packing prtcls 3-7 week turnarund times Reprducibility f clumn perfrmance Supprt fr packing POROS resins in larger clumns Glbal supply chain partner Quality Management System: ISO 9001 and

24 Fr Research Use Only. Nt intended fr any animal r human therapeutic r diagnstic use, unless therwise stated. Pharmaceutical Grade Reagent. Fr Manufacturing and Labratry Use Only Life Technlgies Crpratin. All rights reserved. The trademarks mentined herein are the prperty f Life Technlgies Crpratin and/r its affiliate(s) r their respective wners. Typearl is a registered trademark f Tsh Crpratin. Capt, MabSelect, and MabSelect SuRe are trademarks and Sepharse is a registered trademark f GE Healthcare. Fractgel is a registered trademark f Merck KGaA. 24

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