TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY: …

www.wjpps.com │ Vol 10, Issue 8, 2021. │ ISO 9001:2015 Certified Journal │

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Savale. World Journal of Pharmacy and Pharmaceutical Sciences

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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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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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.

REFERENCES

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PGTJ, 2004; 3-5.

2. Reamer A. Icerman L and Youtie J. Technology Transfer and Commercialization: Their

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5. Ruegger CE, Royce AE and Mollan MJ, Wagner RF, Valazza SJ and Mecadon MR. Scale

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6. Biswajit D and Rao N. Transfer of Technology for Successful Integration into the Global

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7. Trang le.vo, Technology Transfer Challenge in Pharamceutical industry joint CVG /

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8. Ortega A, Arce N, Sequeda F, Gribenchenko I. Management of Innovation and

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