Technology Transfer: - A Buzz Word in Pharmaworld
Swati S. Talokar*, Rohan R.Vakhariya
Rajarambapu College of Pharmacy, Kasegaon Tal Walwa Dist Sangli Maharashtra
Technology transfer is a critical and integral part of drug development process. This path for is dependent on completion of technology transfer to the product site at an affordable cost. The purpose of this review article is to discuss various aspects of technology transfer. This article highlights the goals, importance, facets and various models associated with technology transfer. This article also discuss some of examples of technology transfer in India as well as in global market.
Technology Transfer is defined as “a systematic procedure which controls the transfer of any process along with its documentation and professional expertise between development and manufacture or between two manufacturing sites”. It is a logical procedure that is followed in order to pass the documented knowledge and experience to an appropriate and authorized party. Or simply it may be defined as the practice of transferring scientific findings from one organization to another for further development, so that new products such as medicines, educational tool, electronic devices, safety equipment and health services can be made available to the public.
By following one definition we identify following aspects of technology transfer:-
1. “Techno-ware”: this would include the transfer of physical objects such as equipment for use in research laboratories or production equipment for manufacture of pharmaceuticals ingredients, or formulation or packaging of final products
2. “Human-ware”: skills and human aspects of technology management and learning, such as a training course for researchers or general practitioners across the world.
3. “Info-ware”: all techniques related to knowledge, information and technology in the form of a technology license
4.”Orga-ware”: knowledge needed to operate a given technology relating to a chemical or biological compound.
TYPES OF TECHNOLOGY TRANSFER:
There are two types of technology transfer.
1. Vertical technology transfer refer to transfer of technology from basic research to development and production respectively.
2. Horizontal technology transfer refers to movement and application of technology from one unit to other.
2. IMPORTANCE OF TECHNOLOGY TRANSFER IN PHARMACEUTICAL COMPANIES:
1. To explain information necessary to transfer technology from R and D to actual manufacturing site.
2. To illustrate information to transfer technology of existing products between various manufacturing places
3. It is required to exemplify specific procedures and points of concern for the two types of technology transfer to contribute to smooth technology transfer
4. To establish multiple exploitation partnership
5. To establish collaboration between research institutes and commercial organizations.
3. REASONS FOR TECHNOLOGY TRANSFER:
1. Formation of bond with partners which can take technology to the market.
2. Formation of connection with partners having manufacturing capability.
3. Engaging with partners with marketing and distribution capability
4. Exploring in different fields of application.
5. No Commercial capability.
4. RIGHT CONDITIONS FOR PHARMACEUTICAL TECNOLOGY TRANSFER
Research-based pharmaceutical companies are looking for following prospective in recipient:
1. Promising market scale and accessibility
2. Political stability and transparent governance
3. Appropriate capital markets
4. Innovation-friendly environment with adequate intellectual property rights and effective enforcement
5. Proper access to information
6. Adherence to high regulatory standards
7. Skilled workforce
8. Clear economic development priorities
5. FACETS OF TECHNOLOGY TRANSFER 
The transfer of technology could happen in any of the following way :-
1. Government labs to private sector firm.
2. Between private sector firm of same country
3. Between private sector firm of different country
4. From academia to private sector firm.
5. Academia, government and industry collaboration.
6. STEPS IN TECHNOLOGY TRANSFER PROCESS 
Technology Transfer process consist of 3 phases:
This process includes the design of procedure and selection of materials by R and D department based on innovator product characteristics. The quality of the product should meet the specifications and standards of innovators product carrier.
2. Development Phase:
R and D department must provide the necessary documents to the product development lab that contains all the information of the formulation and drug product. These documents includes:
· Master Formula Card: This contains all the information related to product i.e the product name, its strength, generic name, MFC number, shelf life etc.
· Master Packing Card: This provides information related to packaging type, materials used, stability profile and shelf life of packaging.
· Master Formula: This gives information about the formulation, manufacturing instructions etc.
· Specifications and Standard Test Procedures(STP’s): These consist of active ingredient and excipients profile, in process parameters, product release specifications and finished product details
3. Production Phase:
This phase includes Validation Studies like performance qualification, operation qualification and process validation. It also includes scale up for production that involves the transfer of technology during small scale development of product to larger scale. It is necessary to document every step of technology transfer from R and D to production and it is the responsibility of Quality Assurance Department to check and approve the documentation of all the processes of Technology Transfer.
The necessary documents to be prepared, maintained and inspected during the whole process are as follows:-
· The Research and Development Report is a file which shows the quality design of drug substance and its specifications and methods.
· Technology Transfer Plan describes items and contents of technology to be transferred, its detailed procedures along with transfer schedules and established judgment criteria for completion of transfer.
· Technology Transfer reports are maintained by both transferring and transferred department and are evaluated to confirm that the predetermined criteria are met.
7. METHODS OF TECHNOLOGY TRANSFER
Technology Transfer can be done in various ways such as contract, Research and Development, establishment of joint ventures, setting up plants, licensing patents, designs etc. Licensing is however the most common method of technology transfer that grants the right to use the technology in return for agreed payment.
Two main strategies of Licensing are:-
1. Licensing in:
In this strategy, companies that are small scale industries and which lack facilities to perform basic research would wish to buy other’s research. Also large scale and research based companies also might like to license in technology to expand its product line.
2. Licensing out:
In this, small scale companies that only have patents as their assets and cash in scarce would like to license out, whereas large companies license out technology if it is of very little knowledge for them.
(Ranbaxy, India’s one of the leading pharmaceutical companies, is involved in both licensing in and licensing out opportunities for NDDS, Branded Generics and generics in developed and developing markets. On the other hand, Ranbaxy is looking for out licensing opportunities in therapeutic categories such as respiratory and anti-infective.)
8. MODELS OF TECHNOLOGY TRANSFER 
The managers of technological project, researchers, consultants and practioners who has faced difficulties and complexities of technology transfer have proposed models of technology transfer. These models could facilitate the effective planning and implementation of technology transfer projects.
2 types of technology transfer models are 1) Qualitative 2) Quantitative
Qualitative model have the objective to figure out the activities involved in managing technology transfer and select the factors and issue that can influence the effectiveness of technology transfer.
Quantitative model on other hand aims at quantifying parameters and analyzing them with view of minimizing incompatibility between transferor and transferee.
8.1 Qualitative Technology Transfer Model
Bar-Zakay(1971) developed a technology transfer model based on project management approach. Accoerding to this model technology transfer process is divided into search, adaptation implementation and maintenance stages. Bar-Zakay model has limited relevance today since many of ideas reflectes the setting of late 1960 to early 1970’s when buyers of technology were passive recipient who depended greatly on aid programme for purchase of technology.
Lesson to be learnt from Bar-Zakay model.
1. Comprehensive examination of entire technology transfer process from right research till the post implementation activities should be done.
2. Process approach must be adopted in planning and implementing technology transfer project.
3. Decision points are important so that activities can be strengthened, mistakes corrected or even project can be terminated at any point of time.
2.The Behrman and Wallender model.
Behrman and Wallender (1976) have proposed a seven stage process for technology transfer that may be relevant to multinational corporation.
The 7 stages are
1. Manufacturing proposal and designing a plan to arrive at decision regarding location. Preparing a business case including good resource assessment.
2. Deciding the product design technique to be transferred.
3. Specifying details of related to infrastructure development.
4. Plant construction and production start-up .
5. Adapting the process and product if needed and strengthening production system.
6. Improving the product technology transfer using local skills.
7. Providing external support to strengthen the relationship between transferor and transferee
3.The Chantramonklasri model:
The Chantramonklasri model (1990) who proposed a five phase model.
The 5 phases of model are as
1. Carrying out pre-investment and feasibility study.
2. Developing engineering specification and design, on the basis of feasibility study.
3. Starting capital goods production based on engineering specification and design that have been developed.
4. Instructing comprehensive workforce
5. Commercial production commencement.
8.2 Quantitative Technology Transfer
1.Sharif and Haq (1980) proposed the concept of Potential Technological Distance(PTD) between transferor and transferee.They argued that when the PTD is either too great or too small the effectiveness of transfer is low. It suggest that when a transferee looks for potential transferor it is important to look for one with an ‘optimal’ PTD.
2.Raz et al (1983) have presented a model of technological “catch-up”that shows how a technology leader, can assist the rate of technology development of technology followers. The model examines 3 phases of growth of technology namely the slow initial phase with decreasing gap and catch up phase when technological gap is very small or closed.
3.Klein and Lim (1997) have studied the technology gap between general machinery and electrical and electronic industries of Korea and Japan .This model suggest that the technology transfer from leaders can play a critical role in upgrading the technology level of follower firms. Their study also shows that followers should supplement the transfer by independently putting them in place measure to understand, modify and localize the technology transferred from leaders.
9.TECHNOLOGY TRANSFER DOCUMENTATION:
Technology transfer documentation are generally documents which indicates contents of technology transfer for transferring and transferred parties. The raw data of the documents should be prepared and compiled according to purposes, and should be always readily available and traceable. The task assignments and responsibilities should be clarified, and acceptance criteria for the completion of technology transfer should be transferred .It is desirable to prepare product specification with detailed information of product (drug substances or drug products) subject to transfer, then proceed with the technology transfer according to the plan established on the basis of this specification, and document the results as the report.
Points of Concern for Preparing Technology Transfer Documentation:
For smooth technology transfer, transferring and transferred parties should establish organizations according to GMP guidelines, and appropriately document and record relevant information. It is recommended to prepare the following documents:
1) Documents to clarify applicable technologies, burden shares, responsibilities, and approval systems, etc. concerning the technology transfer written agreements and memorandums, etc
2) Information of transferring and transferred parties
3) Development report
4) Product specifications
5) Technology transfer Plan
6) Technology transfer Report
· Development report:
The goal of successful technology transfer is to have documented evidences. The R and D department files technical development and is in charge of its documentation. This report indicates rationale for the quality design of drug substances and drug specifications and test methods. The development report can be used at the preapproval or as a valid document for quality design of new drug. In addition, this report can be used as raw data in case of post-marketing technology transfer. The development report contains data of pharmaceutical development of new drug substances and drug products at stages from early development phase to final application of approval, information of raw materials and components, rational for dosage form and formula designs and design of manufacturing methods, change in histories of important processes and control parameters, stability profile, specifications and test methods of drug substances, intermediates, drug products, raw materials, and components, which also includes validity of specification range of important tests such as contents impurities and dissolution, rational for selection of test methods, reagents and, columns, and traceability of raw data of those information.
· Technology transfer plan:
The technology transfer plan is to describe items and contents of technology to be transferred and detailed procedures of individual transfer, transfer schedule, judgment criteria for the completion of the transfer. The transferring party should prepare the plan before the implementation of the transfer and reach an agreement on its contents with the transferred party.
Once data are taken according to the technology plan and are evaluated to confirm that the predetermined judgment criteria are met report completion of technology transfer is to be made. Both transferring and transferred parties can document the technology transfer report however, they should reach an agreement on its contents.
After taking scale up batches of the product, manufacturing of exhibit batches take place. In case of exhibit, batch sizes are increased along with equipments and their processes involved. They are done for filing purposes in different regulatory agencies.
10. REASONS FOR UNSUCCESSFULL TECHNOLOGY TRANSFER PROCESS:-
1. Incomplete Process Validation.
2. High rates of batch rejections, excessive labour requirements,increased cost of product etc.
3. Incomplete Documentation.
4. Product does not show specifications as intented.
5. Delayed regulatory approval and/or product launch
11.FEW CASES OF TECHNOLOGY TRANSFER
The process of Technology Transfer is actively being pursued in India through Government laboratories, Academics Institutions and Commercial entities.
1. The Bhabha Atomic Research Centre (BARC) has developed and transferred around 90 technologies in the areas such as environment and health, electronics, electrical and mechanical, chemical and metallurgy, radioisotope and applications.
2. The National Chemical Laboratory (NCL) Pune, has several linkages with universities and pharmaceutical industries to ensure successful scale up and implementation of technology.
3. Department of Biotech(DBT) has successfully transferred some techniques of forest trees through tissue culture.
Progressive pharmaceutical companies should pay more attention to streamline and optimize which would ensure the rapid and successful introduction of new medicinal products to market. Technology transfer will enable pharmaceutical organizations to fully benefit from the recent improvements in the new drug discovery and to complete more effectively in a rapidly changing marketplace. A dedicated technology transfer organization sets up to facilitate and execute the process. Technology transfer can be considered successful if a receiving unit can routinely reproduce the transferred product, process or method against a predefined set of specifications. The research and development centers should have their own model for the management and innovation to make them more versatile evaluating technical and commercial possibilities for new process or new services.
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Received on 03.01.2017 Accepted on 25.01.2017
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