See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/343502179

REVIEW ON TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY;

FACTS AND STEPS INVOLVED

Article in European Journal Pharmaceutical and Medical Research · August 2020

CITATION READS

1 3,287

2 authors:

Rajesh L. Dumpala Chirag Patil

Dr. Reddy's Laboratories Parul Universiy
22 PUBLICATIONS 60 CITATIONS 11 PUBLICATIONS 24 CITATIONS

SEE PROFILE SEE PROFILE

All content following this page was uploaded by Rajesh L. Dumpala on 07 August 2020.

The user has requested enhancement of the downloaded file.

 ejpmr, 2020,7(8), 738-743 SJIF Impact Factor 6.222
Review Article
Dumpala et al. EUROPEAN JOURNAL European
OF PHARMACEUTICAL
Journal of Pharmaceutical and Medical Research
AND MEDICAL RESEARCH ISSN 2394-3211

www.ejpmr.com EJPMR

REVIEW ON TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY; FACTS

AND STEPS INVOLVED

Rajesh Dumpala1* and Chirag Patil2

1
Research Scientist, Department of Formulation & Development (MS&T), Alembic Research Centre, Vadodara,
Gujarat, India.
2
Research Associate, Department of Formulation & Development (MS&T), Alembic Research Centre, Vadodara,
Gujarat, India.

*Corresponding Author: Rajesh Dumpala

Research Scientist, Department of Formulation & Development (MS&T), Alembic Research Centre, Vadodara, Gujarat, India.

Article Received on 03/06/2020 Article Revised on 24/06/2020 Article Accepted on 15/07/2020

ABSTRACT
The Technology Transfer is both integral and critical to drug discovery and development process for new medicinal
products this process gives necessary information for technology transfer from R&D to PDL/T.T/MS&T
department and development of existing product to the production for commercialization. The article attempts to
discuss about the technology transfer process, steps involved in technology transfer, reasons for using technology
transfer, importance of technology transfer and the issues involved in the technology transfer in the pharmaceutical
industry.

KEYWORDS: Technology transfer, Scale up, Exhibit, pharmaceutical production.

FACTS AND STEPS INVOLVED or institution (eg: a company, a university or a

Technology Transfer It is Systematic Documented governmental body) and of acquisition by the others such
evidence to Transfer Analytical Method, Formulation ideas, knowledge, technologies and skills.
Manufacturing Process, and Packaging Method & API
Manufacturing Process from One location to another Application of Technology Transfer in
Location with consistent Performance of Method or Pharmaceutical Industry
Process which will give high degree of assurance that  Formulation Manufacturing Process Transfer
Specific Process or Method will consistently produce a  Analytical Method Transfer
product meeting its predetermined specifications and  Packaging Method Transfer
quality characteristics.  API Manufacturing Process Transfer

World Intellectual property organization (WIPO)

Defines“A series of processes for sharing ideas,
knowledge, technology and skills with another individual

The Technology Transfer Team

Name of Team
Responsibilities of Team Member
Member
The central focus for transfer activities, Collates documentation from donor site, Performs initial
Process
assessment of transferred project for feasibility, compatibility with site capabilities and
Technology
establishes resource requirements.
The reviews documentation to determine compliance with marketing authorization, The reviews
QA
analytical method with QC to determine capability, equipment training requirements, The
Representative
initiate’s conversion of donor site documentation into local systems and format.
The reviews process instructions/ rules with process technologist to confirm capacity and
Production capability, They consider any safety implication Ex. Solvents, toxic and sanitizing materials,
Representative They consider impact on local standard operating procedures, Training requirements of
supervisors and operators.
Engineering The reviews with production representative equipment and Requirements, Initiates required
Representative engineering modifications change or part purchase, Reviews preventative maintenance and

www.ejpmr.com 738
Dumpala et al. European Journal of Pharmaceutical and Medical Research

calibration impact Ex. Use of more aggressive ingredients, more temperature sensitive process
and modifies accordingly.
QC The reviews analytical requirements, The availability with instruments,
Representative The responsible for analytical method transfer for drug substances and drug product.

STAGES FROM F&D TO MAUNFACTURING UNIT

Stage 1 : Literature Search
- Evaluate at least two suppliers fully.
Stage 2 : Active Sourcing
- Request for the samples, COA and Specifications.
- DMF availability
- Compliance with USP monograph
Stage 3 : Active Evaluation - Impurity profile and stability
- Potential Polymorphic forms
- Commitment for physical specifications
Stage 4 : Active Purchasing
Stage 5 : Active Testing
Stage 6 : Innovator's Product Purchasing
- Evaluate physical parameters such as
- Tablet shape
- Tablet color
- Pack sizes containers materials
- Closure types ; cotton and desiccants
- Innovator Physical /Chemical Testing such as
- Weight / Thickness / Hardness
Innovator's - LOD
Stage 7 :
Product Testing - Friability
- Disintegration
- Dissolution
- Related Substance
- Microscopic observation such as
- Particle size
- Crystal shape
- Identification of specific Excipient
- Physical characterization of bulk batch
- Polymorphism
- Particle size distribution
- Bulk density & Tapped density
- Microscopic observation
Bulk Active
Stage 8 : - Chemical characterization
Testing
- Assay
- Stressed Analysis
- Impurity profile
- Optical rotation
- O.V.I. Testing
Excipients
Stage 9 : - Pre-Formulation Studies
Selection
- Manufacturers and suppliers
Container Closure - Material composition
Stage 10 :
System - Requirement of cotton and desiccants
- Manufacturer's DMF numbers for all component parts
- Granulation
- Wet Granulation
- Dry Granulation
Selection of - Dry Mixing
Stage 11 : Manufacturing - Slugging Method
Process - Blending Time Optimization
- Evaluation of Physical Properties of Granules
- Flow properties
- Bulk Density & Tap Density

www.ejpmr.com 739
Dumpala et al. European Journal of Pharmaceutical and Medical Research

- Particle-size distribution
- Compressibility
- Hausner’s Ratio
- Evaluation Physical Properties of Compressed Tablets
- Weight
- Thickness
- Hardness
- LOD
- Friability
- Disintegration
Stage 12 : Bulk Active Purchased
- Dissolution - in USP medium (Multipoint profiles) and other relevant media
Analytical versus Innovator's product
Stage 13 :
Evaluation - Validation of analytical package i.e. Assay; Dissolution, Content Uniformity
completed prior to Process Qualification
Stage 14 : Process Optimization
Stage 15 : Analytical Evaluation
Stage 16 : Scale Up
Stage 17 : Process Qualification - Pre-Exhibit / PO Batch
Stage 18 : Pivotal Production - Exhibit / Submission Batch
Stage 19 : Bio Study Results Evaluation
Stage 20 : Pre-Submission Auditing
Stage 21 : Submission
Stage 22 : Process Validation
Stage 23 : Process Re-validation

When does Technology Transfer occur?  Kilo Lab to Pilot Plant

 Idea to Discovery Lab  Pilot Plant to Semi-works (other pilot plant)
 Discovery Lab to Development Lab  Pilot Plant/ Semi-works to Manufacturing
 Development Lab to Kilo Lab  Manufacturing to Manufacturing
 Lab to Pilot Plant

KNOWLEDGE TRANSFER PROCESS

Need an Effective Transfer Process that plugs the leaks and yields Better Retention

TECHNOLOGY TRANSFER SUCCESS CRITERIA

www.ejpmr.com 740
Dumpala et al. European Journal of Pharmaceutical and Medical Research

Team work, most of the time…….. Sending and Receiving Unit

“ Technology transfer is not a one way street”.

The sending & receiving unit must be equally involved in the process to ensure success.

"You can tell pharmacy finally that we have

a product with three batches on Predetermine specification."

IMPORTANCE OF TECHNOLOGY TRANSFER  Opportunities for contingency supply.

1. Demonstration of Necessary information from
Research & Development to Actual Manufacturing. Function of Technology Transfer
2. Demonstration of Necessary information of existing  DOCUMENTATION (TYPICAL TTD PACKAGE)
Product between Various Manufacturing Places. - Product Development Report (PDR)
3. For the smooth manufacturing of commercial - Master Formula Card (MFC)
Products. - Sampling Protocol
- Master Packaging Card (MPC)
Reason For Technology Transfer - Standard Test Procedure (STP)
 Lack of manufacturing capacity. - Raw Material Inprocess, Finished & Shelf Life
 Lack of resources to launch product Commercially. Specification
 Lack of marketing and distribution Capability.
 Exploitation in a different field of application.  EXECUTION OF SCALE UP, PO / PRE-EXHIBIT,
EXHIBIT, VALIDATION BATCHES
Factors Influencing Technology Transfer  COST REDUCTION
 Good business and manufacturing Practices.  CONTRACT MANUFACTURING
 Potential for competitive pricing.  MANUFACTURING SITE TRANSFER
 Strategic planning.  COMMERCIAL TROUBLE SHOOTING
 Strong economy and environment.  SUPAC LEVEL CHANGES (ANNUAL
 Transparent and efficient regulation. REPORTABLE, CBE & PAS)

www.ejpmr.com 741
Dumpala et al. European Journal of Pharmaceutical and Medical Research

Flowchart For Technology Transfer For Process Optimization And Exhibit Batches

CONCLUSION transfer can be considered successful if a receiving

 The transfer involves cost and expenditure that is unit can routinely reproduce the transferred product,
negotiated and agreed upon by the transferee and process or method against a predefined set of
transferor. The transfer may be said to be successful specifications is agreed with a sending unit and/or a
if the transferee can successfully utilise the development unit.
technology for business gains and eventually  Licensing is an imperative spectacle of technology
assimilate it transfer that has gained momentum in pharmaceutical
 Appropriate efficiency in technology transfer from industry by which pharmaceutical firms can
development to commercialization can be achieved contribute to research and development. Technology
through better communication and documentation by transfer is a complex issue and should be deal with
technology transfer team. A cooperative effort by using holistic approach.
team results in more successful initial and consistency
runs leading to an earlier license, earlier launch and a REFERENCES
greater market share. 1. Domb E. Using TRIZ to Accelerate Technology
 Use of enriched approaches like technology transfer Transfer in the Pharmaceutical Industry; PGTJ,
to the development and start-up of new production 2004; 3-5.
systems will enable pharmaceutical organizations to 2. http://www.research.cornell.edu/cotab
fully benefit from the recent improvements in the new 3. Reamer A. Icerman L and Youtie J. Technology
drug discovery and to complete more effectively in a Transfer and Commercialization: Their Role in
rapidly changing marketplace. Economic Development, EDA Public documents,
 A dedicated technology transfer organization is set up 2003.
to facilitate and execute the process. Technology

www.ejpmr.com 742
 Dumpala et al. European Journal of Pharmaceutical and Medical Research

4. Patel DS. An overview for pharmaceutical industry.

IBAP, 2010; 1-10.
5. http://aspx?ContentID=193
6. www.gsk.com/policies
7. Technology 4sme.net/images/pdf%20floder/ttps_
http://www.chapter_3.pdf.
8. ISPE Good practice guide. Technology transfer.
Tampa, F.L. International Society for
Pharmaceutical Engineering, 2003.
9. Janodia MS, Sreedhar D, Ligade VS, Pise A and
Udupa N. Facts of Technology transfer: A
perspective of Pharmaceutical industry, J.
Intellectual property rights, 2008; 28-34.
10. Ruegger CE, Royce AE and Mollan MJ, Wagner
RF, Valazza SJ and Mecadon MR. Scale up of Solid
Dosage Forms, 2006.
11. Mendes PC. Licensing and Technology Transfer in
the pharmaceuticals Industry Cited, 2010.
12. Reamer A. Icerman L and Youtie J. Technology
Transfer and Commercialization:Their Role in
Economic Development, 2003.
13. Singh A and Aggarwal G. Technology Transfer in
Pharmaceutical Industry: A Discussion. IJPBS,
2009; 1-3.
14. Mahboudi Mand Ananthan BR. Effective factors in
technology transfer in the Pharmaceutical Industries
of Iran: A Case study. The IUP Journal of
Knowledge Management, 2010; 1-2.
15. Biswajit D and Rao N. Transfer of Technology for
Successful Integration into the Global Economy: A
Case Study of the Pharmaceutical Industry in India.
UNCTAD, 2002.
16. Luis Alberto del Río, Nuria Salazar, Carmen Trives,
Guidelines for a pharmaceutical technology transfer
towards a drug manufacturing plant, Bol. Soc.
Quím. Méx, 2007.
17. Del Rio, L.A. Ind. Farm, 2001; 64-68.
18. Bateni M. Selection of Appropriate Technology for
Developing Countries, Tadbir, 2000; 108.
19. http://www.amuasi-paper-edited.pdf.
20. www.ncbi.nlm.nih.gov/pubmed/12613797

www.ejpmr.com 743

View publication stats