Advances in Technology Transfer for the Pharmaceutical Industries: An Overview

 

Gourav Shah¹*, Piyush Kamble², Rohini Shinde¹, Kanchan Ghatge³

 

ABSTRACT:

The technology transfer in the pharmaceutical industries is one of the benefit contributing parameters in R&D and F&D sectors which ultimately catalises industry for profits. To survive in the Indian domestic market of pharmaceuticals most of the pharmaceutical companies now-a-days focusing towards more R&D and F&D. Every profit making company very well known about the inventions which gives profit only when it becomes the product and for that Technology Transfer performs major role. In this review, the attempt is made to focus on the approaches and aspects of technology transfer in pharmaceutical industries with recent advances, procedure and documentation to provide a broad global overview of recentand ongoing initiatives for local production of drugs and elevant technology transfer.

 

 

INTRODUCTION:

According to the revised Japanese Pharmaceutical Affairs Law in July 2003, the manufacturing approval system has been replaced with the manufacturing and marketing approval system in April 2005, resulting in a big change in the Japanese pharmaceutical system and regulations. Under these circumstances, it is highly desired to improve a quality assurance system of drugs at all stages through research and development (R&D), manufacturing and marketing in line with the trends by reviewing the current quality assurance system and its methods including existing Good Manufacturing Practice (GMP) to comply with the new system and adopting achievements of technological progress and international harmonization of pharmaceutical regulations.^1,2

 

In recent years, there is a growing awareness that an appropriate transfer of manufacturing technologies (technology transfer) is important to upgrade drug quality as designed during R&D to be a final product during manufacture as well as assure stable quality transferred for many reasons between contract giver and contract acceptor during manufacture.

 

Also, to assure the drug quality, it is desired to make sure 5 W’s and 1 H, that is what, when and why information should be transferred to where and by whom and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing. For that purpose, it is necessary to establish an appropriate guideline for the technology transfer and upgrade.^3,4

 

The quality assurance system. This guideline categorizes information generated in the processes through pharmaceutical R&D and manufacturing as well as the information flows, discusses information necessary for the technology transfer and communication route, and proposes ideal technological transfer. In the pharmaceutical industry technology transfer is may broadly refer to the processes required for successful progression from drug discovery to product development, clinical trial and full scale commercialization, For the development and transfer of knowledge and manufacturing technologies of finished solid dosages forms. It is usually defined as transferring the product out of the development laboratories or the process development pilot plant into full commercial scale manufacturing facilities.^5,6

 

 

In cases where a secondary commercialization is necessary, it also involves transfer to different facilities in multiple regions and countries. Appropriate technology transfer includes the transfer of scientific information, capability, technological basis of the product and process, and analytical test methods from a knowledge center (donor) to the manufacturing plant (receptor). This process is important to ensure that product quality and performance build in during R & D remains unchanged in full scale commercialization product production. The establishment of technology transfer, process is complex process that typically involves multiple functional areas, such as pharmaceutical and analytical R & D, operations quality, regulatory affairs, and program management.⁷

 

For a typical research-based pharmaceutical company, drug discovery and development can be broken down in to distinct stages which were clearly described in Figure 1.

 

Figure 1 Typical process development work flow in pharmaceutical industry

 

Technology transfer is the process by which developers of technologies make its technology available to a commercial partner. That will exploit the technology. There are two types of Technology Transfer, Vertical and Horizontal. Vertical Technology transfer refers to transfer of technology from basic research to development and production respectively. Whereas Horizontal Technology transfer refers to the movement and application of technology used in one place or context to another place.^8,9

 

Current status of technology transfer

According to WHO, Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible and authorized party. Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies.¹⁰

 

Technology Transfer in Pharmaceutical Industry has been viewed from the perspective of Innovation and Research & Development. Since research is carried out in laboratories on small scale before it could be produced on commercial scale. Thus, Technology Transfer is important for such research to materialize on a larger scale for commercialization especially in case of developing and under developing countries. Technology Transfer is an integral part of New Drug Discovery and development of new medicinal products. Thus if Technology Transfer process to production site is carried out at an affordable cost, the cost of product development would not raise during pilot scale up.¹¹

 

Figure 2: The Departments responsible for successful technology transfer of a product in a pharmaceutical industry

 

This guideline applies to the technology transfer through R&D and production of drugs (chemically synthesized drug substances and drug products) and the technology transfer related to post-marketing changes in manufacturing places. The both technologies include those of manufacturing and quality control (manufacturing methods and tests).

 

Various approaches for technology transfer

The Cabinet Office Advisory Council for Applied Research and Development (ACARD) report on ‘Medical Equipment’ recommended an increase in Government support for research and development and closer collaboration between industry and members of the health care professions. Following the ACARD report and as part of a major new initiative, The British Health-Care Trade and Industry Confederation, the British Health Care Export Council, and The Department of Health and Social Security's Supplies Technology Division sponsored a two-day residential conference, on 27 and 28 May 1987 at Brunel University, UK, to address key aspects of technology transfer and innovation along with other major issues arising from the report.¹² The financial cost of getting the technology transfer wrong can be significant, a product that is six months late to market could miss out on one-third of the potential profit over the product’s lifetime.¹³ The extent to which American, European and Japanese pharmaceutical multinational enterprises (MNE) with subsidiaries in the republic of Ireland have localized specific forms of R&D and contributed to technology transfer.¹⁴ A marketing exchange approach to technology transfer will facilitate successful technology transfer and commercialization. A conceptual frame work is presented from which a view government technology transfer efforts.¹⁵

 

Technology transfer had little impact on the assistive technology industries serving small, highly fragmented “disability markets.” Persons with disabilities often require specialized, relatively sophisticated technology. Transferring technology to the industry segments therefore poses special challenges. Successful transfers resulting from the project demonstrate that a systematic technology transfer process can be successfully applied to industries serving specialized and underserved niche markets.¹⁶ In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization. Challenging, seemingly impossible problems arise and speed the progress of new pharmaceuticals to market. The TRIZ concepts of increasing ideality, elimination of tradeoffs, and elimination of inherent (physical) contradictions are applied to the improvement of testing, reduction of toxicity, and scale up for production in several areas of the pharmaceutical industry.¹⁷ The studies on post trip behaviour of domestic and foreign pharmaceutical firms in respect of technology acquisition, knowledge transfer and domestic R&D in India. It evaluates the prospects of development of capabilities by domestic in a scenario where they have also chosen to enter the markets for generic in developed countries and build relations of subcontracting with multinational corporations in the sphere of R&D and production activities. He concluded that due to introduction of strong IPRs, pharmaceutical multinationals are now advantageously placed to control knowledge diffusion and integrate the local capabilities of a country like India into their own myopic and narrowly benefiting innovation strategies. Evidence available from the experience of developing countries like India on the diffusion of knowledge contradicts the claim of TRIPs advocates that its adverse effect on price of on patented medicines would be adequately compensated by the benefits of technology transfer and domestic R&D. The domestic industry is told to utilize emerging market opportunities for contract manufacture and R&D in a selective way.¹⁸

 

The special investigation report on international technology diffusion through trade and patenting in a sample of 48 countries for the period 1980-2000 were analysed. The sample is divided in three income groups to detect different patterns of technology absorption. Our results showed that rich countries benefit from domestic technology and foreign technology embodied in imported capital goods, middle-income countries enjoy technology spill over from foreign patents and imported capital good and poor countries benefit mainly from foreign patents. The government policies on intellectual property rights protection and trade openness have large effects on foreign technology spill over in middle-and low-income countries.¹⁹ Companies should treat technology transfer as a key lever of their operational strategy and establish a comprehensive approach to ensure ongoing best practices. Generally, companies that have mastered technology transfer manage it proactively as a core competency of strategic importance. Quality inspections fewer question regarding chemistry and manufacturing control elements, fewer inspection days, and fewer FDA-483 observations. Moreover, validation runs for API, formulation, and analytical methods have been successful on their first attempt eliminating the need for repeated runs to validate the processes.²⁰ To support the decision process of appropriate technology transfer to industrially developing countries by improving a broader understanding of relationships between the key micro and macro ergonomics factors and the technology alternatives. An attempt was made to briefly identify factors affecting the success of technology transfer in order to reduce the potential of incompatibilities with respect to micro and macro ergonomics and to optimize the decision process of managers. The objective of the decision model, based on the analytic hierarchy process (AHP), determines the global priority weights for different technology alternatives and examines the critical factors and benefits, which affect the appropriateness of technology transfer.²¹

 

A close look at the manner in which legal provisions in technology transfer licenses affect can be used as a means of generating profit, protecting investment and facilitating use of pharma products, and giving some practical suggestions for the drafting of license terms.²² A return to centre for academic technology transfer offices (TTOs) by focusing on a most important question for drivers of our present global knowledge economy, how well does a TTO facilitate access to knowledge protected by intellectual property of its faculty and institution? This article proposes that academic technology transfer performance depends upon knowledge of TTO. Given that performance measures are also referred to as “metrics,” we call this preferred outcomes orientation an access metric.²³ Technology transfer and concluded that technology transfer contributes Quality-by-Design and identifying critical quality attributes the key manufacturing parameters that affect those attributes, and ways to control those manufacturing parameters.²⁴ The facets of technology transfer and concluded that normally technologies are created in developed countries and benefits of these technologies are not spilled over to people in the developing countries. It is essential to make these technologies easily and economically available to people in developing countries. Licensing is one such phenomenon of technology transfer that has gained momentum in pharmaceutical industry whereby pharma companies can contribute to research and development. It was concluded that some aspects of technology transfer can improve research and development activities to meet the newer challenges.²⁵

 

Technology transfer process

The drug quality is designed based on basic data concerning efficacy and safety obtained from various studies in preclinical phases and data concerning efficacy, safety and stability of drug products obtained from clinical studies. The quality of design will be almost completed in Phase II clinical study. Various standards for manufacturing and tests will be established in process of reviewing factory production and Phase III study to realize the quality of design, and the quality of design will be verified in various validation studies, and will be upgraded to be the quality of product, and the actual production will be started. The technology transfer consists of actions taken in these flows of development to realize the quality as designed during the manufacture. Even if the production starts, the technology transfer will take place in processes such as changes in manufacturing places. The processes are classified broadly into the following five categories. ^{25- 27}

 

Quality Design (Research Phase)

The quality design is to design properties and functions of drugs, and often performed in phases from late preclinical studies to Phase II study. For drug products, the quality design corresponds to so-called pharmaceutical design to design properties and functions such as elimination of adverse reactions, improvement of efficacy, assurance of stability during distribution, and adding usefulness based on various data such as chemical and physical properties, efficacy, safety and stability obtained from preclinical studies. For drug substances, the quality design is to determine starting materials and their reaction paths, and basic specifications of the drug substances.

 

Scale-up and Detection of Quality Variability Factors (Development Phase)

Research for Factory Production

To manufacture drugs with qualities as designed, it is required to establish appropriate quality control method and manufacturing method, after detecting variability factors to secure stable quality in the scale-up validation that is performed to realize factory production of drugs designed on the basis of results from small-scale experiments. In general, this process is called the research for factory production where the quality of design will be upgraded to be the quality of product.

 

Consistency between Quality and Specification

When the product specification is established on the basis of the quality of product determined in the above, it is required to verify that the specification adequately specifies the product quality. (Consistency between quality and specification)In short, the consistency between quality and specification is to ensure in the product specification that the quality predetermined in the quality design is assured as the manufacturing quality, and the product satisfies the quality of design.In reviewing factory production, since manufacturing methods are established with limited amount of lots and limited resources of raw materials, the product specification should be established based on data from study results with limited lots; however, relations between upper and lower limits of manufacturing formula (compositions and manufacturing methods) and upper and lower of control limits of the product specification should be fully understood, and the consistency between the product quality and specification should be maintained.

 

Assurance of consistency through development and manufacturing

To make developed product have indications as predetermined in clinical phases, the quality of design should be reproducible as the quality of product (assurance of consistency). For this purpose, the transferring party in charge of development should fully understand what kind of technical information is required by the transferred party in charge of manufacturing, and should establish an appropriate evaluation method to determine whether a drug to be manufactured meets the quality of design.

 

It should be recognized that technical information of developed product are generated from data of a limited amount of batches, various standards have been established from the limited data, and quality evaluation method established in development phase is not always sufficient for factory production. For stable production of consistent products, it is fundamental to fully refer to information of similar products of the past maintained by the manufacturer when research for factory production is implemented, and this is a key to successful technology transfer.

 

Technology Transfer from R&D to Production

Transfer of technical information is necessary to realize manufacturing formula established in the above in the actual production facility. In the past, the technology transfer was mainly seen as standard transfer or as technology instruction from technology department to production department within the same company. In future, since contract manufacturing is expected to increase under the revised Pharmaceutical Affairs Law, the technology transfer between companies will increase. In principle, how accurately transfer technical information (know-how) from transferring party to transferred party is important, and it is essential to establish responsibility system and prepare documents clarifying 5 W’s(why, when, where, what, which) and 1 H (how), and have adequate technology exchange between the both parties for successful transfer.

 

When transfer technology of new products from research and development department to production department, technical information to be transferred should be complied as research and development report (development report and recommend using the development report as a part of technology transfer documentations).

 

Validation and Production (Production Phase)

Production is implemented after various validation studies verify that it is able to stablyproduce based on transferred manufacturing formula. While the manufacturing facility accepting technology is responsible for validation, the research and development department transferring technology should take responsibility for validations such as performance qualification (PQ), cleaning validation, and process validation (PV) unique to subject drugs. For validations such as installation qualification (IQ) and operational qualification (OQ), which are not unique to the subject drugs, it is possible to effectively use data of already implemented validations.

 

Feedback of Information Generated from Production Phase and Technology Transfer of Marketed Products

As a result of technology transfer, products are manufactured and brought to the hands of consumers. Since the technical information of developed products are obtained from data of a limited amount of batches, various standards have been established from the limited data, and quality evaluation method established in development phase is not always sufficient for factory production, it is highly desired to feed back and accumulate technical information obtained from repeated production, if necessary. Also, it is important to appropriately modify various standards established before on the basis of these information, and accountability (responsibility for giving sufficient explanation) and responsibility (responsibility for outcomes of actions) for design and manufacturing should be executed. For this purpose, appropriate feedback system for technical information and documentation management of technology transfer should be established. For drugs as they have long product shelf life, documentation management should be performed assuming that the technology transfer would occur several decades after the completion of development. Also since product improvements and changes of specifications and methods are often implemented, the initial technical information should be reviewed and updated at regular intervals.

 

Procedures and documentation of technology transfer

To properly transfer technology according to the above processes, documentation of technology transfer including appropriate procedures and technical documents is necessary. Procedures and documentation of technology transfer are indicated as follows. ^{28, 29}

 

Organization for Technology Transfer

One of the most significant elements for successful technology transfer is close communication between transferring and transferred parties. Therefore, organization for technology transfer should be established and composed of both party members, roles and scope of responsibilities of each party should be clarified and adequate communication and feedback of information should be ensured. It is desirable that this organization complies with GMP.

 

Research and Development Report

To realize quality assurance at all stages from drug development to manufacturing, transfer of technical documents concerning product development or corresponding documents should be considered.

 

Figure 3: Historical data of pharmaceutical development of new drug substances and drug products at stages from early development phase to final application of approval

The research and development report (development report) is a file of technical information necessary for drug manufacturing, which is obtained from pharmaceutical development, and the research and development department is in charge of its documentation. This report is an important file to indicate rationale for the quality design of drug substances and drug products including information such as raw materials, components, manufacturing methods, specifications and test methods. The development report should also include the above rationales, and it is desirable to document the report before the approval inspection. Although the development report is not prerequisite for the application for approval, it can be used at the pre-approval inspection as valid document for the quality design of new drug. Also, this report can be used as raw data in case of post-marketing technology transfer. The following exemplifies information to be contained in the development report.

 

Technology Transfer Documentation

Technology transfer documentation is generally interpreted as documents indicating contents of technology transfer for transferring and transferred parties. The raw data of the documents (such as development report) should be prepared and compiled according to purposes, and should be always readily available and traceable. For successful technology transfer, task assignments and responsibilities should be clarified, and acceptance criteria for the completion of technology transfer concerning individual technology to be transferred. In principle, 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 technology transfer plan established on the basis of this specification, and document the results as the technology transfer report.

 

Product Specification (Product Specification File)

The product specification is to compile information which enables the manufacture of the product, and to define specification, manufacturing and evaluation methods of the product and its quality, and the transferring party is responsible for documenting the file. For new products, the development report can be used as a part of product specification file. The product specification file should be reviewed at regular intervals, and incorporate various information obtained after the start of production of the product, and be revised as appropriate.The product specification file should contain the the basic information required for start and continuation of product, quality assurance of the product, operation safety data, environmental impact assessment, cost information and specific information of particular product.

 

Technology Transfer Plan

The technology transfer plan is to describe items and contents of technology to be transferred and detailed procedures of individual transfer and transfer schedule, and establish 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.

 

Technology Transfer Report

The technology transfer report is to report the completion of technology transfer after data of actions taken according to the technology plan is evaluated and the data is confirmed pursuant to the predetermined judgment criteria. Both transferring and transferred parties can document the technology transfer report; however, they should reach an agreement on its contents.

 

Check and Approval by Quality Assurance Department

It is desirable that the quality assurance department should establish confirmation process forall kinds of technology transfer documentation, and should check and approve the documentation.

 

For Implementation of Technology Transfer

Avoid as much as possible the technology transfer from transferring to transferred party only by handing over the technology transfer documentation.It is recommended that the both parties should cooperate to implement technology education, training and validations at facilities where the transferred technology is actually used.

 

Manufacturing Related Documents Including Drug Product Standards

The transferred party should compile documents such as drug product standards necessary for manufacturing, various standards and validation plans/reports after the completion of technology transfer. While the transferred party is responsible for compiling these documents, the transferring party should make necessary confirmation for these documents.

 

Verification of Results of Technology Transfer

After the completion of technology transfer and before the start of manufacturing of theproduct, the transferring party should verify with appropriate methods such as product testing and audit that the product manufactured after the technology transfer meets the predetermined quality, and should maintain records of the results.

 

Scope of technology transfer

Each time there is a change in scale, there is technology transfer. Technology transfer is critical for achieving rapid scale-up with control over how the manufacturing process is achieved. A general recipe can be converted into a master recipe for batch control in a specific plant at a given scale. “This conversion is a matter of identifying which recipe parameters are sensitive to scale and replacing class-based parameters with instance-based parameters.”

 

Ideally, development and manufacturing teams share a common information model for process definitions. “This model would capture process definitions and parameters in a machine-readable format that can be rendered into documents for human interactions. ^{28, 29}

 

The technology transfer business formed in accordance with the demand increases in this kind of technology outsourcing can make it simple and efficient along with market activation. If the required technology can be supplied easily and competitively, this can reduce the need and scale of in-house R&D, and will be useful for companies in securing competitiveness through the preoccupation of opportunities in the market. Furthermore, in terms of costs, there is a strong point in that cost savings can be gained with the reduction in R&D organization maintenance costs.

 

Start up and process definitions directly affect manufacturing yield and waste.  When technology transfer transmits Quality by design (QbD) limits and definitions to manufacturing, “waste is reduced by eliminating trial and error in setting up the process,” By giving manufacturers complete knowledge of the process and a framework for continuous improvement, technology transfer improves yields. in several ways; technology transfer enables continuous improvement of the manufacturing process. After ensuring that the process is clearly defined with general recipes, technology transfer sets the stage for recipe harmonization. Recipe harmonization, the use of common formats for all recipes across the product life cycle, forms a basis for process-knowledge management.

 

When technology transfer is performed correctly, it benefits all stages of a product’s life cycle. To begin with, “technology transfer, combined with QbD and programmatic interfaces to commercial manufacturing systems, greatly reduces time to market. Effective technology transfer affects time to market most during the 12–48-month period it takes to scale up from pilot to commercial scale. Recipe harmonization and normalization can reduce the time to achieve commercial-scale production by months. ³⁰

 

CONCLUSION:

In the pharmaceutical industry now-a-days technology transfer has got tremendous importance cause of global synchronization in the production area. Many of pharmaceutical companies have their R & D unit, production unit and packing unit at different places. To maintain the quality of product throughout the process pipeline to the final finished product the technology ought to transfer from pilot plant to the scale up unit. Technology transfer along with process analytical technology³¹ performs the major role in this. The three primary considerations to be addressed during an effective technology transfer are the plan, the persons involved, and the process. A plan must be devised to organize the personnel and the process steps. To assure the drug quality, it is desire to make sure that is what, when, and why information should be transferred to where and by whom and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing.

 

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Received on 06.03.2014          Modified on 01.05.2014

Accepted on 05.05.2014         © RJPT All right reserved