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PHARMACEUTICAL INDUSTRY
SEMINAR PRESENTATION
Institutional Guide:
Prof. Amrita Bajaj
HOD, Pharmaceutics
SVKMs Dr. Bhanuben Nanavati
College of Pharmacy
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Presented By:
Kunal Nitin Prabhu
M.Pharm (Pharmaceutics)
Ist year, Semester-I
Roll No: 15
26-09-2014
Presentation Outline
Technology Transfer: Introduction
Importance of Technology Transfer
Steps involved in Technology Transfer
Methods of Technology Transfer
Factors influencing technology transfer
Scale-up: Introduction
Scale-up Methodology
Scale-up of solid dosage forms
Key references
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Drug
Discovery and
Product
Development
Pre-Clinical
and Clinical
Trials
Full Scale
Commercialization
development
Reduced risk and cost on drug discovery
Better marketing and commercial capability
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Master Formula
Production Phase
Validation Studies
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Scale-up studies
different countries
From academia to Pvt. Sector firms
Collaboration between: Academia, Industry
and Govt.
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Quality
Assurance
Engineering
Representative
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Production
Representative
Quality
Control
sectors
Strong economy and environment
Transparent and efficient regulation
Access to new machinery, training and knowhow.
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resources
Labor issues
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Case Study: 1
PolyPeptide Grp: MNC: Denmark, Sweden,
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Scale-up: Introduction
Increasing the batch size
Applying the same process to different output
volume
Pilot Plant: Lab scale formula is transformed
into viable product through labile practical
procedure.
R&D
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Pilot
Scale
Plant
Scale
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Considerations in Scale-up
Personnel requirements
Space requirements: Storage, Mfg., testing etc.
Raw materials and Processing equipment
Production rate / frequency
Master manufacturing formula
Physical and chemical stability of the product
Compliance with GMP
Quality Assurance
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Steps in Scale-up
Product
economics,
market
competitiveness
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Laboratory
studies & scale-up
plan
Key controlling
steps. Preliminary
larger than lab
studies
Evaluation of
pilot scale results.
Decision for Fullscale production
Pilot Plant:
Design &
Construction
Dry Blending
Compression
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Granulation
Drying
Drying:
Air flow and air temperature
Amount of granules to be placed
Drying time at specified temperature
Compression:
Granule feed rate of the press
No change in particle size distribution
Neither segregation of coarse and fine particles nor
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Case Study: 2
Carbogen Amcis: Multi-national company, mfg. and
Conclusion:
Appropriate Technology transfer: Important to upgrade
Key References:
Surbhi G et al. Technology transfer in Pharmaceutical Industry-An Overview,
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Acknowledgements
Prof. Amrita Bajaj
Prof. Mayur Yergeri (Principal)
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