TECHNOLOGY TRANSFER AND SCALE-UP IN

PHARMACEUTICAL INDUSTRY
SEMINAR PRESENTATION

Institutional Guide:
Prof. Amrita Bajaj
HOD, Pharmaceutics
SVKMs Dr. Bhanuben Nanavati
College of Pharmacy
1

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
2

SVKM's Dr. Bhanuben Nanavati College of Pharmacy

26-09-2014

Technology Transfer: Introduction

Developer of technology makes his technology

available to a commercial partner who

exploits the technology.

Drug
Discovery and
Product
Development

Pre-Clinical
and Clinical
Trials

Full Scale
Commercialization

SVKM's Dr. Bhanuben Nanavati College of Pharmacy

26-09-2014

Importance of Technology Transfer

Necessary information of product tech. transfer
Robust and effective manufacturing procedures
Benefits of R&D to society
Successful and timely drug/product

development
Reduced risk and cost on drug discovery
Better marketing and commercial capability

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

Reasons for Technology Transfer

Lack of manufacturing capacity
Lack of resources for product commercialization
Lack of marketing and distribution capability
Exploitation in different field of application

26-09-2014

Steps involved in Technology Transfer

Research
PhaseQuality and
Procedure design
and
Excipients Selection
Specifications
Development Phase

Master Formula

Standard Test Procedure

Production Phase
Validation Studies
6

Scale-up studies

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

Facets of Technology Transfer

Govt. labs to private sector firms
Between Pvt. sector firms of the same or

different countries
From academia to Pvt. Sector firms
Collaboration between: Academia, Industry
and Govt.

26-09-2014

Technology Transfer cycle

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

Methods of Technology Transfer

Sale of technology
Licensing of Technology
Capital, Management and know-how
Technical personnel as medium

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

Technology Transfer team

Process
Technologist

Quality
Assurance

Engineering
Representative

10

Production
Representative

Quality
Control

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

Factors influencing Technology Transfer

Good business and manufacturing practices
Competitive pricing between public and private

sectors
Strong economy and environment
Transparent and efficient regulation
Access to new machinery, training and knowhow.

11

26-09-2014

Barriers and Issues in Technology transfer

Lack of efficiency
Low market share of local producers
Outsourcing of technology by companies
Ineffective scale-up and timely allocation of

resources
Labor issues

12

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

Factors for effective Technology Transfer

Proper managerial and strategic planning
Investment in R&D, proper training of personnel
Scientific attitude , creation of standards
Timeline, cost-saving objectives
Highly skilled, dedicated team
Customer focused strategy
Proper and timely communication
Compliance, safety and regulations.

13

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

Case Study: 1
PolyPeptide Grp: MNC: Denmark, Sweden,

14

France, India (Ambernath), USA.

Indian facility: Tech. transfer from USA: 2 generic
peptide APIs
Key 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.
26-09-2014

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
15

Pilot
Scale

Plant
Scale

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

Objectives of Pilot plant Scale-up

Investigation of product/process on intermediate scale
Evaluation and improvement of process, if any.
Design of large complex mfg. plant
Identification of critical process parameters
Master mfg. formula
Physical and chemical stability of formulation.

16

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

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

17

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

Steps in Scale-up
Product
economics,
market
competitiveness

18

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

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

Scale-up of Solid dosage forms

Material
handling /
Processing &
weighing

Dry Blending

Compression

19

Granulation

Drying

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

Considerations of scale-up for different

processes
Blending Operations:
Time and speed of blending
Blender load
Size of blender

Fluidized Bed Granulation:

Optimum load
Air flow rate
Inlet air temperature
Humidity of incoming air
20

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

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

induction of static charges

21

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

Case Study: 2
Carbogen 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.
22

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

Conclusion:
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.
23

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

Key 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, JulySept.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.

24

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

Acknowledgements
Prof. Amrita Bajaj
Prof. Mayur Yergeri (Principal)

25

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

26

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