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TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY:
PROCESS TRANSFER FROM DEVELOPMENT TO
COMMERCIALIZATION
Sagar Kishor Savale*
Technical Operations and Services Scientist, Viatris LTD, Sinnar, Nashik,
Maharashtra 422113, India.
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 highlights the
objective, reasons for undergoing technology transfer, factors which
affect technology transfer, steps involved in technology transfer
process. Clearly explains the technology transfer documentation part
this is an attempt to understand the aspects related to technology
transfer. The journey of a brand-new compound from a quest
laboratory followed by pilot plant production then proportion batches
whereas below going through validation to a commercial product. This article explains a
significant choice centres around where the thought or cycle is progressed from a pharma
research-situated program focuses on commercialization.
KEYWORDS: Technology transfer, PDL, Manufacturing Services, Technical Services,
Product Development, Process Development.
INTRODUCTION
To co-ordinate for transfer of technology and risk assessment of new molecule and product at
site for R & D and site transfer products. Technology Transfer It is Systematic Documented
evidence to Transfer Analytical Method, Formulation Manufacturing Process, and Packaging
Method & API Manufacturing Process from One location to another Location with consistent
WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
SJIF Impact Factor 7.632
Volume 10, Issue 8, 972-981 Review Article ISSN 2278 – 4357
*Corresponding Author
Sagar Kishor Savale
Technical Operations and
Services Scientist, Viatris
LTD, Sinnar, Nashik,
Maharashtra 422113, India.
Article Received on
03 June 2021,
Revised on 23 June 2021,
Accepted on 13 July 2021
DOI: 10.20959/wjpps20218-19588
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Savale. World Journal of Pharmacy and Pharmaceutical Sciences
Performance of Method or Process which will give high degree of assurance that Specific
Process or Method will consistently produce a product meeting its predetermined
specifications and quality characteristics. Technology Transfer includes, Formulation
Manufacturing Process Transfer, Analytical Method Transfer, Packaging Method Transfer,
API Manufacturing Process Transfer.
Technology transfer occur,
Figure 1: Technology transfer process.
Importance of technology transfer
Demonstration of Necessary information from Research & Development to Actual
Manufacturing.
Demonstration of Necessary information of existing Product between Various
Manufacturing Places.
For the smooth manufacturing of commercial Products.
Technology transfer is helpful to develop dosage forms in various ways as it provides
efficiency in process, maintains quality of product, helps to achieve standardized process
which facilitates cost effective production.
Function of technology transfer
Documentation (Typical TTD package): Product Development Report (PDR), Master
Formula Card (MFC), Sampling Protocol, Master Packaging Card (MPC), Standard Test
Procedure (STP), Raw Material In-process, Finished & Shelf Life Specification, Product
Development Summery (PSD), Product Transfer details (PTD), Product performance
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qualification protocol (PPQP), Product performance qualification report (PPQR), Process
evaluation plan (PEP), Process evaluation report (PER). Additional sampling and testing
plans, Hold time study protocols and reports.
Manufacturing batches: Execution of Scale Up, Pre-Exhibit, Exhibit, Validation Batches,
Cost Reduction, Contract Manufacturing, Manufacturing Site Transfer, Commercial Trouble
Shooting, Supac Level Changes (Annual Reportable, CBE & PAS).
Stage of technology transfer in drug development
Figure 2: Stages of technology transfer for drug development.
Reasons for comming of technology transfer
Not Accepted Manufacturing Capacity
Lack of Resources to Launch Product Commercially
Lack of Marketing And Distribution Capability
Exploitation In a Different Field Of Application
Goals of technology transfer
Is a valuable step in the developmental life cycle leading to successful commercial
manufacturing of drug in drug product development life cycle. To take all the gathered
knowledge and use it as the basis for the manufacturing control strategy, the approach to
process qualification and on-going continuous improvement. The transition of the
product/process/analytical method knowledge between development and manufacturing sites.
To ensure variability of process and parameters are controlled and sufficient in the face of the
commercial production environment to verify parameters established during development are
still within the determined design space and/or adjusted at scale-up.
Factors influencing technology transfer
Good business and manufacturing Practices
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Potential for competitive pricing
Strategic planning
Strong economy and environment
Transparent and efficient regulation
Technology transfer team
The various persons involved in the process of technology transfer are:
Figure 3: Technology transfer teams.
Technology transfer team Members and Their responsibilities
Table 1: Technology transfer team Members and Their responsibilities.
Technology transfer
team members Responsibilities
Process technologist
Central focus for transfer activities
Collates documentation from the donor site
Performs initial assessment of the transferred project for
Feasibleness, Compatibility with site capabilities and Establishes
resource needs
QA representative
Reviews documentation to work out compliance with marketing
authorization (MA)
Reviews analytical strategies with QC to work out capability,
instrumentation training requirements
Initiates conversion of donor site documentation into local systems
or format
Initiates or confirms regulatory needs, e.g., an amendment to
manufacturing license; variations to MA if method changes
needed, etc
Production
representative
Reviews process instructions (with process technologist) to verify
capacity and capability
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Considers any safety implications, e.g., solvents; toxic; sanitizing
materials
Considers the impact on local standard operating procedures
(SOPs)
Considers the training requirements of supervisors or operators
Engineering
representative
Reviews (with production representative) instrumentation
requirement
Initiates required engineering modifications, change or part
purchase
Reviews preventative maintenance and calibration impact, e.g., use
of a lot of aggressive ingredients; more temperature-sensitive
method, and modifies consequently
QC representative
Reviews analytical requirement
Availability with instruments
Responsible for analytical technique transfer for drug substance
and drug product
Flowchart for technology transfer for process Optimization and Exhibit batches
Figure 4: Flowchart for technology transfer for process Optimization and Exhibit
batches.
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New product tech transfer process
Figure 5: New product tech transfer process.
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Technology transfer for site transfer products
Figure 6: Technology transfer for site transfer products.
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Savale. World Journal of Pharmacy and Pharmaceutical Sciences
Stages from f & d to manufacturing unit
Table 2: Stages from F & D to manufacturing unit.
Stage 1 Literature Search
Stage 2 Active
Sourcing
Evaluate at least two suppliers fully.
Request for the samples, COA and Specifications.
Stage 3 Active
Evaluation
DMF availability
Compliance with USP monograph
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
Stage 7
Innovator's
Product
Testing
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
- LOD
- Friability
- Disintegration
- Dissolution
- Related Substance
- Microscopic observation such as
- Particle size
- Crystal shape
- Identification of specific Excipient
Stage 8 Bulk Active
Testing
- Physical characterization of bulk batch
- Polymorphism
- Particle size distribution
- Bulk density & Tapped density
- Microscopic observation
- Chemical characterization
- Assay
- Stressed Analysis
- Impurity profile
- Optical rotation
- O.V.I. Testing
Stage 9 Excipients
Selection - Pre-Formulation Studies
Stage 10
Container
Closure
System
- Manufacturers and suppliers
- Material composition
- Requirement of cotton and desiccants
- Manufacturer's DMF numbers for all component parts
Stage 11 Selection of
Manufacturing
- Granulation
- Wet Granulation
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Process - Dry Granulation
- Dry Mixing
- Slugging Method
- Blending Time Optimization
- Evaluation of Physical Properties of Granules
- Flow properties
- Bulk Density & Tap Density
- Particle-size distribution
- Compressibility
- Hausner’s Ratio
- Evaluation Physical Properties of Compressed Tablets
- Weight
- Thickness
- Hardness
- LOD
- Friability
- Disintegration
Stage 12 Bulk Active Purchased
Stage 13 Analytical
Evaluation
- Dissolution - in USP medium (Multipoint profiles) and other
relevant media, versus Innovator's product
- 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 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
Stage 24 Commercialization
CONCLUSION
To achieve a successful technology, transfer the most important points to be considered is
teamwork with good understanding and communication between the sending unit and the
receiving unit. Building up a strong and constantly improved cycle related to Drug Quality
Systems guarantees meeting or to surpass GMP necessities. It will also depend upon the
documentation which includes dossier given by the research unit as well as the overall
documentation in which QA is involved which is a community-oriented exertion with
Research and Development, Manufacturing Specialized Operations, Quality, Manufacturing
and so on that is expected to guarantee a fruitful innovation move and a robust last made
item. Such a small initiative may lead to getting regulatory approvals in a short duration as
well as the formulation will be ready to compete the already existing marketed product in a
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very short period. If the process of technology transfer takes place in a proper way it may
contribute to enhancing the productivity and economic growth of an organization without
making sacrifices with the quality of the formulation. Successful technology transfer will
ensure the timely product filing, approval and Launch of drug product.
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