Note from Authors: transfer journey to collaboratively establish a common. ISPE_China_Nov. 15, Company Confidential 2015 Eli Lilly and Company 2
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1 Technlgy Transfer: The Future f Pharmaceutical Prduct Cmmercializatin i Drs. Xiaming Li, Timthy T. Kramer, Duglas Kjell, and Matthew Yates Nvember 15, 2015 Eli Lilly and Cmpany
2 Nte frm Authrs: Technlgy transfer has been gaining mre attentin in the Pharmaceutical sectr because f its accelerating expansin in dimensin and magnitude with everincreasing cmplexity. Glbal cllabratin, including China, is essential fr the future success f ur industry. We wuld like t share experiences with ur technlgy transfer jurney t cllabratively establish a cmmn practice enabling future successful transfers. Cmpany Cnfidential 2015 Eli Lilly and Cmpany 2
3 Outline Brad Definitin Expanded Dimensin and Magnitude (timing, scale, cntent, ) Essential Success Factrs Challenges Cmpany Cnfidential 2015 Eli Lilly and Cmpany 3
4 Technlgy Transfer Definitin ISPE: The systematic prcedure that is fllwed in rder t pass the dcumented knwledge and experience gained during develpment and/r cmmercializatin t an apprpriate, respnsible, and authrized party. Technlgy transfer embdies bth the transfer f dcumentatin and the demnstrated ability f a Receiving Unit t effectively perfrm the critical elements f transferred technlgy, t the satisfactin f all parties and any, r all, applicable regulatry bdies. ICH Q10 (3.1.2): The gal f technlgy transfer activities is t transfer prduct and prcess knwledge between develpment and manufacturing, and within r between manufacturing sites t achieve prduct realizatin. This knwledge frms the basis fr the manufacturing prcess, cntrl strategy, prcess validatin apprach and nging cntinual imprvement. Cmpany Cnfidential 2015 Eli Lilly and Cmpany 4
5 Technlgy Transfer - Definitin Definitin (cntinued) Gal: t transfer a demnstrated slutin (and key dependencies) in a systematic, dcumented manner Measure: knwledge, capability, and dcumented evidences Receiving Site Sending Site Cmpany Cnfidential 2015 Eli Lilly and Cmpany 5
6 Technlgy Transfer - Dimensin & Magnitude Timing: thrugh the entire prduct life cycle Lcatin: acrss the glbe Scale: frm prttype t t full cmmercial prductin Cnceptual Design Prduct Develpment Cmmercializatin Lifecycle Management Cmpany Cnfidential 2015 Eli Lilly and Cmpany 6
7 Technlgy Transfer Success Factrs Understand Science D it right Understand cmpliance nature D it effectively Understand d peple D it tgether, efficiently Cmpany Cnfidential 2015 Eli Lilly and Cmpany 7
8 Technlgy Transfer Success Factrs Understand Science Raw Material Physical Prperty Impact n Tablet Mechanical Strengthth Case Study #1: Will the same lt f micrcrystalline cellulse behave the same? Cmpany Cnfidential 2015 Eli Lilly and Cmpany 8
9 Technlgy Transfer Success Factrs Understand Science (Case Study #1) Study Design: Material Cmmn pre-blend batch Sieved MCC PH200 frm ne single lt then added as extra granulatin Sieved MCC: 20% w/w Prcess Direct Cmpressin Data Cllectin Multi-pint i t trend vs. single data pint Result: Same lt f MCC (but different e particle size fractins) changed tablet breaking frce by ver 20%. Cmpany Cnfidential 2015 Eli Lilly and Cmpany 9
10 Technlgy Transfer Success Factrs Understand Science (Case Study #1) Differing Perfrmance Result: Neither tablet slid fractin (thickness) nr cmpressin frce was able t predict the strength f resulting tablets. Similar Prfiles Cmpany Cnfidential 2015 Eli Lilly and Cmpany 10
11 Technlgy Transfer Success Factrs Understand Science (Case Study #1) Sieved Micrcrystalline Cellulse, PH 200 Cmpany Cnfidential 2015 Eli Lilly and Cmpany 11
12 Technlgy Transfer Success Factrs Understand Science (Case Study #1) Tablet Frmatin Bnding / Binding Mechanisms Cmpany Cnfidential 2015 Eli Lilly and Cmpany 12
13 Technlgy Transfer Success Factrs Understand Science (Case Study #1) Tablet Frmatin Bnding / Binding Mechanisms Cmpany Cnfidential 2015 Eli Lilly and Cmpany 13
14 Technlgy Transfer Success Factrs Understand Science (Case Study #2) Design a Technlgy Transfer based n Engineering i 1 st Pi Principlesi Case Study #2: Scale up and Transfer f Fluidized Bed Pellet Cating Prcesses Cmpany Cnfidential 2015 Eli Lilly and Cmpany 14
15 Technlgy Transfer Success Factrs Understand Science (Case Study #2) Fluid Bed Pellet Cating Material: Sugar Spheres Equipment: Fluid Bed Prcessr Cmpany Cnfidential 2015 Eli Lilly and Cmpany 15
16 Technlgy Transfer Success Factrs Understand Science (Case Study #2) Fr a nn-adiabatic system r a fluid bed prcessr, a thermal energy balance can be written as, T T ( ) m 1 f ΔH m in, air C p in, air exhaust suspensin 1 ΔH slids v ε = M air M H O 2 where, m in, air = mass flw rate f inlet air M air = mlecular weight f air T in, air = inlet air temperature T exhaust = exhaust temperature m suspensin = mass flw rate f suspensin p M H2 O = mlecular weight f water f slids = slids fractin f suspensin ΔH v = latent heat f vaprizatin f water C p = heat capacity f air ε = heat transfer efficiency f a given fluid bed prcessr, determined empirically Cmpany Cnfidential 2015 Eli Lilly and Cmpany 16
17 Technlgy Transfer Success Factrs Understand Science (Case Study #2) Overall Energy Balance: r, Energy Input Energy Cnsumed = Energy Stred (Tinlet air, Qinlet air flw, Qatmizatin air flw) (mspray rate, Texhaust air, Qexhaust air flw) =(Tprduct= (Tprduct, E pellets ) and the bundary cnditins are, Thermdynamic Energy Balance: (T H inlet air, Q H inlet air flw) (m L spray rate) => (T H prduct) (T L inlet air, Q L inlet air flw) (m H spray rate) => (T L prduct) Kinetic Energy Balance: (Q H inlet air flw, Q H atmizatin air flw) => (E H pellets) (Q L inlet air flw, Q L atmizatin air flw) ) => (E L pellets) ) Nte: The actual values f the DOE bundary cnditins (i.e., air flw, air temperature, spray rate) can be determined based n the data frm initial trials and predicted by the thermdynamic mdel. The DOE is executed t determine the impact f the kinetic respnse f the system (i.e., atmizatin air, air flw). This apprach increases the prbability f successful trials at the bundary cnditins. Cmpany Cnfidential 2015 Eli Lilly and Cmpany 17
18 Technlgy Transfer Success Factrs Understand Science (Case Study #2) Half Factrial Design Prcess Respnse Atmizatin Air Pressure Inlet Air Temperature Nte: Spray rate was kept cnstant t maximize i prduct thrughput. h t Result: Kinetic energy (atmizatin air) plays a crucial rle in cntrl pellet agglmeratin cmpared t thermdynamic energy. Prdu uct Bed Temp perature % Aggl merates Prcess Time Prduct Respnse DOE 1: T,in = L, Air Flw = L, P,atm = H DOE 2: T,in = H, Air Flw = L, P,atm = L DOE 3: T,in = L, Air Flw = H, P,atm = L DOE 4: T,in = H, Air Flw = H, P,atm = H Ramp-Up Stage DOE Stage Prcess Time Cmpany Cnfidential 2015 Eli Lilly and Cmpany 18
19 Technlgy Transfer Success Factrs Understand Science (Case Study #3) Accelerate Knwledge Acquisitin Using Statistical ti ti Mdeling Case Study #3: Are Tablet Attributes Predictable? Cmpany Cnfidential 2015 Eli Lilly and Cmpany 19
20 Technlgy Transfer Success Factrs Understand Science (Case Study #3) Establish Targets fr Tablet Physical Attributes (Nte: fr a given frmulatin) Independent Variables Filling Depth Main Cmpressin Tip-t-Tip Distance Respnses Equipment and Material: Cmpressin Frce Prduct (Tablet): Tablet Weight Tablet Thickness Tablet Breaking Frce Cmpany Cnfidential 2015 Eli Lilly and Cmpany 20
21 Technlgy Transfer Success Factrs Understand Science (Case Study #3) Linear Mdel (Predicts mean respnse fr each attribute) Prbability Mdel (Prbability that individual tablet attributes all fall within desired ranges) Ti ip t Tip Di istance, mm m Tablet Breaking Frce Mean, kn Main Cmpressin Frce, kn Tip t Tip Distance, mm Dsing Psitin, mm Tablet Thickness Mean, mg Dsing Psitin, mm Bundaries defined by linear mdel nly prvide 50% chance that cnstraining factr will meet desired gal. Prbability mdel ensures that essentially all tablets will simultaneusly meet desired ranges. 11/23/2015 Cmpany Cnfidential 2015 Eli Lilly and Cmpany 21
22 Technlgy Transfer Success Factrs Understand Science (Case Study #3) Mdelling Predictin and Actual Results Predictin Actual Filling Depth (mm) Main Cmpressin Tip-t-Tip Distance (mm) Main Cmpressin Frce (kn) Tablet Thickness (mm) Tablet Breaking Frce (kp) Cmpany Cnfidential 2015 Eli Lilly and Cmpany 22
23 Technlgy Transfer Success Factrs Understand Cmpliance Nature Cdes and Regulatins Cnstructin Envirnment Health and Safety Transprtatin Imprtatin and Exprtatin cgmp Cmpany Cnfidential 2015 Eli Lilly and Cmpany 23
24 Technlgy Transfer Success Factrs Understand Peple Prject Leadership Strategic thinker Appraches "In Parallel vs. Sequential Effective Leader Establishes prductive gvernance structure Uses well-defined grund rules Plans the wrk and wrks the plan Implementatin Der Fcuses n tangible utcmes and practical slutins Effectively manages Zming In and Zming Out Inspiratinal Mtivatr Gains team cmmitment and alignment Influential Cmmunicatr Knws the audience, stakehlders, and spnsrs Knws what t cmmunicate, when and hw Cmpany Cnfidential 2015 Eli Lilly and Cmpany 24
25 Technlgy Transfer - Challenges An individual event with its wn persnality A cllabrative, integrated effrt acrss functins and business partners A dynamic envirnment full f unexpected cmplexities Subject t tremendus pressure t d the technlgy transfer right and faster Cmpany Cnfidential 2015 Eli Lilly and Cmpany 25
26 Technlgy Transfer Challenge Individual Event Each prduct has its unique histry r persnality Each team member has his/her wn experience, knwledge, and persnal insights Each functin and party has their wn pririty and fcus Each sending /receiving site has their wn culture and fllws their wn practice Cmpany Cnfidential 2015 Eli Lilly and Cmpany 26
27 Technlgy Transfer Challenge Integrated Effrt Cre Team Prject leader Analytical Engineering Science & Technlgy Quality Regulatry Sending Site Prcurement Health, Safety & Envirnment Operatin Supply Chain Finance Marketing R&D Reference Standards External Envirnment Cnsumers Regulatry Agencies External Partners Receiving Site Legal IT Transprtatin Imprt & Exprtatin Lcal Culture Cmpany Cnfidential 2015 Eli Lilly and Cmpany 27
28 Technlgy Transfer Challenge Dynamic Envirnment Change in Membership Cmplete a multi-year relay Different needs at each phase f a transfer Peple s career prgressin Change in Suppliers Preference fr lcal suppliers Change in Technlgy Transfer yesterday s technlgy t serve tday s need Change in Regulatin Gverned by different regulatry bdies Cmply with tmrrw s regulatin Cmpany Cnfidential 2015 Eli Lilly and Cmpany 28
29 Technlgy Transfer Challenge Tremendus Pressure Timing: Scpe: Why can t it be dne faster? What has t be changed? Cnsistency : Peple: Hw can similarity be prved even thugh things are changed? Wh knw nt nly what yu cannt d, but als what yu can d? Cmpany Cnfidential 2015 Eli Lilly and Cmpany 29
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