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TECHNOLOGY TRANSFER AND SCALE-UP IN PHARMACEUTICAL INDUSTRYInstitutional Guide:Prof. Amrita BajajHOD, PharmaceuticsSVKMs Dr. Bhanuben Nanavati College of PharmacyPresented By: Kunal Nitin PrabhuM.Pharm (Pharmaceutics)Ist year, Semester-IRoll No: 15

SEMINAR PRESENTATION126-09-20141Presentation OutlineTechnology Transfer: IntroductionImportance of Technology TransferSteps involved in Technology TransferMethods of Technology TransferFactors influencing technology transferScale-up: IntroductionScale-up MethodologyScale-up of solid dosage formsKey references

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26-09-2014SVKM's Dr. Bhanuben Nanavati College of PharmacyTechnology Transfer: IntroductionDeveloper of technology makes his technology available to a commercial partner who exploits the technology.

3SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Importance of Technology TransferNecessary information of product tech. transferRobust and effective manufacturing proceduresBenefits of R&D to societySuccessful and timely drug/product developmentReduced risk and cost on drug discoveryBetter marketing and commercial capability

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SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Reasons for Technology TransferLack of manufacturing capacityLack of resources for product commercializationLack of marketing and distribution capabilityExploitation in different field of application

526-09-2014Steps involved in Technology Transfer6SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Facets of Technology TransferGovt. labs to private sector firmsBetween Pvt. sector firms of the same or different countriesFrom academia to Pvt. Sector firmsCollaboration between: Academia, Industry and Govt.7

26-09-2014Technology Transfer cycle8

SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Methods of Technology TransferSale of technologyLicensing of TechnologyCapital, Management and know-howTechnical personnel as medium9

SVKM's Dr. Bhanuben Nanavati College of Pharmacy

26-09-2014Technology Transfer team10SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Factors influencing Technology TransferGood business and manufacturing practicesCompetitive pricing between public and private sectorsStrong economy and environmentTransparent and efficient regulationAccess to new machinery, training and know-how.11

26-09-2014Barriers and Issues in Technology transferLack of efficiencyLow market share of local producersOutsourcing of technology by companiesIneffective scale-up and timely allocation of resourcesLabor issues

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SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-201412Factors for effective Technology TransferProper managerial and strategic planningInvestment in R&D, proper training of personnelScientific attitude , creation of standardsTimeline, cost-saving objectivesHighly skilled, dedicated teamCustomer focused strategyProper and timely communicationCompliance, safety and regulations.13

SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Case Study: 1PolyPeptide Grp: MNC: Denmark, Sweden, France, India (Ambernath), USA.Indian facility: Tech. transfer from USA: 2 generic peptide APIsKey elements: Raw material, Equipment, Packaging, Analytical Method transfer.Technical Aspects: Plant, equipment construction, Process parameters, Need for further adjustments.Training of personnel: At PolyPeptide USA, GMP compliance.Result: Multiple mfg. lines, multi-kg batch size. Solid Phase Peptide synthesis.

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26-09-2014Scale-up: IntroductionIncreasing the batch sizeApplying the same process to different output volumePilot Plant: Lab scale formula is transformed into viable product through labile practical procedure.

15SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Objectives of Pilot plant Scale-upInvestigation of product/process on intermediate scaleEvaluation and improvement of process, if any.Design of large complex mfg. plantIdentification of critical process parametersMaster mfg. formulaPhysical and chemical stability of formulation.16SVKM's Dr. Bhanuben Nanavati College of Pharmacy

26-09-201416Considerations in Scale-up Personnel requirementsSpace requirements: Storage, Mfg., testing etc.Raw materials and Processing equipmentProduction rate / frequencyMaster manufacturing formulaPhysical and chemical stability of the productCompliance with GMPQuality Assurance

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26-09-2014Steps in Scale-up18SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Scale-up of Solid dosage forms19SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Considerations of scale-up for different processesBlending Operations:Time and speed of blending Blender loadSize of blender

Fluidized Bed Granulation:Optimum loadAir flow rateInlet air temperatureHumidity of incoming air

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SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Drying:Air flow and air temperatureAmount of granules to be placedDrying time at specified temperature

Compression:Granule feed rate of the pressNo change in particle size distributionNeither segregation of coarse and fine particles nor induction of static charges 21SVKM's Dr. Bhanuben Nanavati College of Pharmacy

26-09-2014Case Study: 2Carbogen Amcis: Multi-national company, mfg. and supply of intermediates / APIs for pre-clinical use to large-scale mfg.Transfer of complex, multi-step process from Switzerland. Tech. transfer master plan, lab and pilot-scale studies, compliance with regulatory and quality standards.Process from Switzerland (1600 L) transferred to India: In 5 months (scaled-up to 4000 L). Benefit of reduced costs.Process transfer (Manchester to India) and scale-up from 600 kg to 1500 kg. campaigns.Further capacity expansion to 28 metric tonnes planned.

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26-09-2014Conclusion:Appropriate Technology transfer: Important to upgrade the quality of design, quality of product, ensure stable and high quality of the product.The three primary considerations to be addressed during an effective technology transfer; Plan, persons involved and the process. In order to scale up and transfer a process successfully from laboratory scale to pilot scale and multiple commercial manufacturing scales, understanding of the integration of scale factors, facility design, equipment design and process performance is necessary.

23SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014Key References:Surbhi G et al. Technology transfer in Pharmaceutical Industry-An Overview, Internationale Pharmaceutica Sciencia, 2012, Vol. 2 (3)Amrita K et al, Technology Transfer: A New Buzz Word in Pharmaceutical Industry, Journal of Advanced Scientific Research, 2013, 4(1): 01-06.Singh A, Aggarwal G. Technology Transfer in Pharmaceutical Industry, A discussion. International Journal of Pharma and Biosciences, July-Sept.2009,1(3).1-5.Ali S, Pandit V, Chander S. Technology Transfer in Pharmaceuticals, International Research Journal of Pharmacy, 2012; 3(6): 43-48.Michael Levin, Pharmaceutical Process Scale-up, Second edition, 2006, Informa healthcare, Pg. 8-12.Liberman, H., Lachman, L. and Kanig, J , The Theory and Practice of Industrial Pharmacy, Third edition, Varghese Publishing House, 1987, Pg. 681-702.Shashank Tiwari et al, Process Scale-up of Ibuprofen tablet, Journal of Pharmaceutical Sciences and Research, 2011, Vol.3 (10), Pg.1525-1529.

24SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014AcknowledgementsProf. Amrita BajajProf. Mayur Yergeri (Principal)25SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-201426

SVKM's Dr. Bhanuben Nanavati College of Pharmacy26-09-2014