In any technology transfer process there are two primary parties involved. For any method, a comprehensive gap analysis should be undertaken to identify any parameters that would require additional validation as part of the transfer process. Susan schniepp, distinguished fellow, and andrew harrison, chief regulatory affairs officer and general counsel, both of regulatory compliance associates, discuss requirements for successful product technology transfer. Technology transfer as the process of pharmaceutical. In pharmaceutical industry preparation of dosage form needs scale. This article identifies some aspects of technology transfer that is shaping pharmaceutical industry and its research and development activities to meet the newer challenges and some relevant examples of technology transfer in pharmaceutical industry. In the pharmaceutical industry, technology transfer refers to the processes of successful. The international conference on harmonisation of technical requirements for the registration of pharmaceuticals for human use provides a very powerful statement on the importance of technology transfer 1.
The technology transfer throughout the life cycle as well as transfers of manufacturing processes from one site to another during the commercial production phase 1. A formal system is recommended to track these changes during the transfer process. Key considerations for successful technology transfers. In pharmaceutical industry, technology transfer refers to the procedures of effective advancement from drug discovery to commercialization of the drug, clinical trials and ultimately fullscale commercialization.
Technology transfer sample protocol in pharmaceuticals. International transfer pricing in the ethical pharmaceutical. For those in the other, tech transfer is a perennially new frontier with surprises at every turn. Pharmaceutical companies are increasingly adopting technology transfer strategies to gain a foothold in the russian, chinese and brazilian markets, where there are high barriers to entry. Transfer of analytical methods for pharmaceutical analysis transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. In pharmaceutical industry, technology transfer refers to the processes of successful progress from drug discovery to product development, clinical trials and ultimately full scale commercialization. Technology innovation in pharma industry, health news, et.
Pharmaceutical technology transfer training course. Pharmaceutical technology transfer jobs, employment. Joseph szczesiul, director of technical services for upm pharmaceuticals, shares best practices. Associate director, office of manufacturing and product quality. Apply to pharmacy technician, manufacturing specialist, information technology manager and more. Factors that have facilitated international technology transfer include. Abstract technology transfer plays a vital role in the process of drug discovery to the product development and the full scale commercialization. Hagen accelerating trends in the pharmaceutical industry have made successful technology transfer more critical than ever.
Technology transfer helps companies increase cost competitiveness by leveraging the low manufacturing costs in those regions. Analytical method transfer best practices contract pharma. Technology transfer guidelines for pharmaceuticals. Each organization should adopt a policy or procedure to manage transfers of technology in a structured and. Transfer pricing symptoms of chronic industry challenges. A major decision focuses on that point where the idea or process is advanced from a research oriented program to target toward commercialization. My company is preparing to transfer in a new product to one of our manufacturing facilities. For those in the first group, technology transfer is a mature discipline that follows a structured approach, with predictable outcomes.
Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated. Blockchain technology in the pharmaceutical industry. Horizontal transfer is the movement of technologies from one area to another 1. This would ultimately need to be assessed against current ich guidelines. Pdf technology transfer in pharmaceutical industry.
The main objective of this study is to provide the clear procedure for technology transfer process in pharmaceutical industry. How process validation guidance simplifies tech transfer. Party b shall deliver to jv such proprietary technologies represented by the supporting patents and knowhow owned or controlled by it and reasonably necessary for the manufacturing of recombinant sct and recombinant pth, and shall during the term of this agreement, deliver such other proprietary technologies owned or controlled by party b as may be reasonably necessary to manufacture. For any biopharmaceutical manufacturer, commercial success depends on being able to increase drug substance production volume quickly and effectively and to move production freely without being locked into one provider. Recognition of this has resulted in a new usp chapter transfer of analytical procedures, and an update to chapter 6 of the. Constituents and factors of technology transfer in. Technology transfer by design the next stage in operational advantage by pedram alaedini, ronald d.
The local production of pharmaceuticals and related technology transfer. This report was originally a study commissioned by a number of leading pharmaceutical companies into the transfer pricing of ethical pharmaceutical products, i. In pharmaceutical industry preparation of dosage form needs scale up at several stages, such as small scale laboratory development. Technology transfer in pharmaceutical industry request pdf. Review on technology ijpqa, volume 7, issue 1, january 2016 march 2016 page 10 attitude and commitment to the transfer project, technological status, business orientation inward versus outward, economic status, and stability. Were especially proud of the pharmaceutical sector, which plays an. The article attempts to discuss the issues associated with technology transfer in the pharmaceutical industry. Local production of pharmaceuticals and related technology. Marketing intangibles have been the subject of heated debates in the transfer pricing tp arena for a number of years. A further detail ed steps involved in technology transf er is described by understanding the problems associated during technology transfer. Technology transfer in practice by green s and warren p, 2002, sue horwood publishing limited, storrington, west sussex, uk. Introduction to technological transfer in the pharmaceutical.
Technology transfer and pharmaceutical quality systems fda. A series of case studies by the unctad secretariat 1. Productivity gains only result from the natural diffusion of innovation to the marketplace technology transfer. Technology transfer in the pharmaceutical industry for. International transfer pricing in the ethical pharmaceutical industry why this book. New product transfers during development through manufacturing. Process technology transfer solutions in pharma manufacturing. Research on technology transfer in the pharmaceutical industry by yue feifei and yue yingming. African dialogue on technology transfer for local manufacturing capacity on drugs and vaccines by dr. What is a technology transfer in pharmaceutical contract. Planning for successful technology transfer pharmaceutical. Pharma tech transfer a framework for technology transfer to. Once described as throwing processes over the wall, tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied.
There is a process for bringing ideas from the lab into the market and we call this process, technology transfer. Cork 15 minutes from jack lynch tunnel thursday may 11th 2017 one of the technical challenges for the pharma industry is the transfer of process technology between. Review on technology transfer in pharmaceutical industry manu c, n vishal gupta pharmaceutical quality assurance group, department of pharmaceutics, jss college of pharmacy, jss university, sri shivarathreeshwara nagara, mysuru 570015, karnataka, india. May 22, 2012 a framework for technology transfer to satisfy the requirements of the new process validation guidance. A perspective of pharmaceutical industry article pdf available in journal of intellectual property rights 1. The guidance provided in the ispe technology transfer guide is the result of the collaboration of many individuals representing a broad spectrum of the healthcare industry. Sop on transfer of technology for manufacturing process. The term technology transfer refers to the process of movement of technology from one unit to another. 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 fullscale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology. Technology transfer projects for local production 65 annex ii. Review on technology transfer in pharmaceutical industry. Process technology transfer solutions in pharma manufacturing hovione plant, loughbeg, ringaskiddy, co. The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and.
Mar 11, 2016 in the pharmaceutical industry, the goal for rapid development and efficient commercialization of drugs is continuous and ongoing. Transfer pricing practical cases pharmaceutical sector. Jul 15, 2014 technology transfer in pharma industry, technology transfer in pharmaceutical industry, pharmaceutical technology transfer, pharma tech transfer, naseeb basha, slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Requirements for product technology transfer pharmaceutical. Technology transfer embodies both the transfer of documentation and the demonstrated.
In pharmaceutical industry, technology transfer is the practice of transferring scientific findings from one organization to another for further development so that new products such as medicines, educational tools and health services can become available to the public. Annex 7 who guidelines on transfer of technology in. Image courtesy of the author technology scaleup and transfer are commonand crucialbiodevelopment activities. Apr 27, 2017 technology innovation in pharma industry. Who guideline on transfer of technology in pharmaceutical manufacturing.
Transfer pricing practical cases pharmaceutical sector agenda 3. This blog post will describe several best practices regarding technology transfer of manufacturing processes between several sending and receiving sites across a. Supply chain security is one aspect that has recently won atten. Technology transfer as the process of pharmaceutical quality system. Technology transfer is a mature process in the pharmaceutical industry. Technology transfer projects for local production 73. Modelling technology transfer as a process strategy 300 the goal of our scientific and practical investigations was to develop a strategy and standardized approach to technology transfer as to the one of the main basic processes of pharmaceutical quality system. Transactional net margin methods transfer pricing rules 4. The article highlights the objective, reasons for undergoing technology. Identify and mitigate risks in technology transfer processes understand main roles and responsibilities of the stakeholders of technology transfer process manage project changes managing technology transfer projects in pharma in the dynamic world of pharma significant changes need to be handled on a. Facts and steps involved manish singh manral1, bharat prashar1, yakub sheikh1 1.
Seeking a credible and suitable partner, however, stretches further than technological proficiency or available capacity. The traditional model of setting up subsidiaries is complicated, time consuming. In pharmaceutical industry technology transfer refers to the processes of successful progress from drug discovery to product development, clinical trials and ultimately full scale commercialization a technology transfer is a logical procedure that controls the transfer of any process together with its documentation and professional expertise. Technology transfer in pharmaceutical industry remya mariam john abstract in todays business setting, interest in the profitable exploitation of a firms technological assets, through technology transfer, has intensified. How we measure reads a read is counted each time someone. Technology transfer in pharmaceutical industry the pharma. Schoner, dimitris kourouklis, philipp sandner, erick gonzalez, jonas forster with this paper, we present a blockchainbased solution to increase supply chain security for the pharmaceutical industry. Gupta p, agrawal a, sara u, 20, technology transfer in pharmaceutical industry, international journal of universal pharmacy and bio sciences.
Blockchain technology in the pharmaceutical industry manuela m. Pharmaceutical production and related technology transfer. The greater environment which is that surrounding both the transferor and the transferee. 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 fullscale commercialization 2. Transfer of analytical methods for pharmaceutical analysis. Technology transfer agreement by and between shijiazhuang. Technology transfer pharmaceutical training courses, pharma. Technology transfer in pharma industry, technology transfer in pharmaceutical industry, pharmaceutical technology transfer, pharma tech transfer, naseeb basha, slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Researchers looking to simplify compound identification, quantitation and complex data analysis now have access to a wide range of software and cloud. Who guidelines on transfer of technology in pharmaceutical manufacturing 1. Local production of pharmaceuticals and related technology transfer in developing countries. Ich guideline q10 on pharmaceutical quality system step 5. In pharmaceutical industry, technology transfer refers to the processes of successful progress from drug discovery to product development.
Technology transfer is a complex issue and should be deal with using holistic approach. Logistical implications, for example, should be taken into account, because the change of site and scale may require seeking a new source of api or excipients as well as lead to difficulties once largescale production is necessary. Technology transfer plays a vital role in the process of drug discovery to the product development and the full scale commercialization the article attempts to discus about the pharmaceutical technology transfer process steps, reasons and importance of technology transfer and the issues involved in the technology transfer in the pharmaceutical. Apr 23, 2015 key considerations for successful technology transfers apr 23, 2015 the pharmaceutical industry is constantly engaged in transferring processes between organizations or locations. The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between. A systematic approach to tech transfer and scaleup.
Technology transfer is a process to transfer information and technologies necessary to manufacture quality drug product consistently or technology transfer is the process of taking an invention from its inception in a. Part 2 in the life of any drug product, the technology transfer of a process is a complex matter, made more complicated by the new definition of the process validation pv guidance issued by fda in january 2011. It is the intersection between business and science and it is both integral. An overview of eight country case studies this series of case studies on local pharmaceutical production and related technology transfer in argentina.
Ich guideline q10 on pharmaceutical quality system european. Researchbased pharmaceutical industry programs provide insights for policy makers as technology transfer is poorly captured in official statistics, this booklet. Universities, hospitals, and research centres conduct a lot of groundbreaking research that are responsible for creating medications that. Transfers within or between manufacturing and testing sites for marketed products.
A collaborative approach to improve global health i. This classroom course on pharmaceutical technology transfer identifies criteria for successful technology transfer and provides how to examples which can be individually tailored, depending on the type and scope of transfer. To development and transfer knowledge and technology has been and will continue to be critical to success in pharmaceutical industry. Technology transfer technical services in pharmaceutical industry presentation pdf available december 2018. Throughout this guideline, the term pharmaceutical quality system refers to the ich q10. What people said about technology transfer the course was quite informative and the discussions with the group we of great value, this will obviously impact positively and lead to improvement in our current operations it was a useful course and nice to have answers instead of it depends which you often hear on courses. Technology transfer and the drug discovery and development process technology transfer is both integral and critical to the drug discovery and development process for new medicinal products. Technology transfer and pharmaceutical quality systems. Entities majority of companies do not have license agreements with federal government half of the companies were founded on the basis of a license agreement.
Transfer pricing symptoms of chronic industry challenges some of the notable trends in the current landscape of the pharmaceutical industry bring about complex transfer pricing tp dilemmas that require companies to tailor their tp strategy accordingly. Licensing is an important phenomenon of technology transfer that has gained momentum in pharmaceutical industry by which pharmaceutical companies can contribute to research and development. Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfer in pharmaceutical industry citeseerx. The transfer may be said to be successful if the receiving unit and the transferee can effectively utilize the technology for business gain. Technology transfer in the sme sector the bitcoin question currency versus trustless transfer technology fastrack pharmaceuticals. Findings on initiatives for local production and technology transfer. Developing a robust and continually improved process in conjunction with pharmaceutical quality systems assures meeting or exceeding gmp. Technology transfer is important for such researcher to.
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