Industrial Pharmacy Assignment 1

Assignment on Technology Transfer- By Pankaj Paul Roll No -50 Technology Transfer Barriers and Challenges Pankaj Paul School of Pharmaceutical Technology, Adamas Knowledge City. Barasat Kolkata -700126 [email protected] INTRODUCTION development to realize through the quality as designed during the manufacture. Even if the production starts, T echnology transfer refers to the process of the technology transfer will take place in process such movement of technology from one unit to as changes in manufacturing places. The processes are another. The transfer may be said to be classified into the three categories :. successful if the receiving unit and the transferee can (i). Research Phase effectively utilise the technology for business (ii). Development Phase gain.Technology Transfer, also called Transfer of (iii). Production Phase Technology (TOT), is the process of transferring (i).Research Phase skills, knowledge, technologies, methods of Design of procedure and selection of excipients by manufacturing, samples of manufacturing and R&D Selection of materials and design of procedures facilities among industries, governments or is developed by R&D on the basis of innovator universities to ensure that scientific and technological product characteristics. For this different test and developments are accessible to a wider range of users compatibility studies are done. who can then further develop and exploit the technology into new products, processes, applications, materials or services IMPORTANCE OF TECHNOLOGY TRANSFER Drug products quality design corresponds to In pharmaceutical industry preparation of dosage form pharmaceuticals design-to-design properties and needs scale up at several stages, such as small scale functions such as elimination of adverse reactions, laboratory development from 0.5 – 2 kg batch can be improvement of efficacy, assurance of stability during scaled up to 5/10kgs and then to 20/100kg on a pilot distribution & adding usefulness based on various data scale Generally scale up involves the transfer of such as chemical and physical properties, efficacy, technology and the transfer of knowledge that has safety and stability obtained from preclinical studies. been accumulated during the small scale development For drug substance quality design is used to determine of product and processes. Research is carried out in starting materials their reaction paths and basic laboratories on an experimental scale (small batches) specification of the drug. Identification of before it could be produced for commercial use (large specification and quality by R&D Quality of product batches). Technology transfer is important for such should meet the specification of an innovator product research to materialize on a larger scale for for this different stability studies are carried out for commercialization especially in the case of developing innovator product and for product which is to be product.Technology transfer includes not only the manufactured. patentable aspect of production but also includes the ii. Development Phase (Technology transfer from business of processes, such as knowledge and skills. R&D to production) Technology transfer provides an opportunity to reduce cost on drug discovery and development thus major R&D provides technology transfer dossier (TTD) pharmaceutical companies look for technology document to product development laboratory which transfer opportunities as it reduces the risk, cost and contains all information of formulation and drug rate of failure. product as given below; STEPS IN TECHNOLOGY TRANSFER Technology Transfer Dossier (TTD) The quality of design will be almost completed in TTD contained all the information of drug product as phase II clinical study. Various standards for given manufacturing and test will be established in process below: of reviewing factory production and phase III study to realize the quality of design, if design will be verified Master formula card (MFC) in various validation studies will be upgraded to be the Master Packaging Card (MPC) quality of product and the actual production will be Master formula started.Technology transfer consists to action taken in Standard Test Procedures these flows of Specifications AU/2017/06/0001486 Page 1

Assignment on Technology Transfer- By Pankaj Paul Roll No -50 Development report When product specification is established on the basis Packaging development report of thequality of product determined in the above, it is Master formula card (MFC) required to verify that the specification adequately MFC included Product name along with its Strength, specifies the product quality. In short, the consistency Generic name, MFC number, Page number, Effective between quality and specification is to ensure in the date, shelf life, market, packaging details, storage products specification that the quality predetermined conditions, precautions for personnel safety as well as in the quality design is assured as the manufacture for the product safety. Ingredients details with quality and the product satisfies the quality of design. pharmacopoeial status along with the specifications Assurance of consistency through development and numbers, brand names / grades along with approved manufacturing vendors label claim and a brief manufacturing detail. To make developed product have indications as Masters packaging card predetermined in clinical phases, quality of design It gives information about packaging type, material should be reproducible as the quality of product use for packaging, stability profile of packaging and (assurance of consistency). For this purpose shelf life of packaging. transferring party in charge of development should Master formula fully understand what kind of technical information is It describes formulation order and manufacturing required by the transferred party in charge of instruction. Formulation order and manufacturing manufacturing and should establish an appropriate instruction gives idea of process order, environment evaluation method to determine whether a drug to be condition required and manufacturing instruction for manufactured meets the quality of design dosage form development. Technology transfer from R&D to production Specification and standard test procedure (STPs) Transfer of the technical information is necessary to It helps to know active ingredients and excipients realize manufacturing formula and actual production profiles, in process parameter and specification, facility. Technical information to be transfer should be product release specification and finished product compiled as R&D report. detail. iii. Production Phase Research for factory production Validation studies To manufacture drugs with qualities as designed, it is Production is implemented after various validation required to establish appropriate quality control studies verify that, it is able to consistently method and manufacturing method, after detecting manufacture product based on transferred variability factors to secure stable quality in the scale manufacturing formula with a higher degree of up validation that is performed to realize factory stability. Research and development department production of drug designed on the basis of result transferring technology should take responsibility for from small-scale experiments. validation such as performance qualification, cleaning validation and process validation unique to subject drugs. Consistency between quality and specification Scale-up AU/2017/06/0001486 Page 2

Assignment on Technology Transfer- By Pankaj Paul Roll No -50 Scale up followed after getting all information from opens up the opportunity for trading across R&D. It involved the transfer of technology and the the entire world. transfer of knowledge. From sifting to film coating • National security issues and restrictions on each process had its own set of challenges. The exports of particular technology: development of robust formulation and process International controls designed to protect through the use of Design of Experiments (DoE) as national security and to prevent the well as understanding the critical v/s non-critical proliferation of important technologies also parameters for each operation were be major restrict the flow of technologies. determining factors for success v/s failure on scale-up. • Inadequate funding in important areas and The following chapter focused on the same of the possible treaties: There are areas of research scale-up issues and considerations for several unit of importance to the developing world that operations that may be utilized during the manufacture are being funded inadequately. of solid dosage forms. Full scale commercialization • Labour issues: The pharmaceutical sector includes: Active Pharmaceutical Ingredient (API), demands relatively skilled labour. High Drug product (dosage form or delivery system), labour turnover and absenteeism owing to analytical methods. unattractive conditions of service is negative Considerations of different parameters for scale-up contributor. Before starting scale-up, we also considered different Approaches to overcome barriers in technology parameters that should be optimum for successful transfer : technology transfer. These were: Flexibility, Cost, • Commercializing publicly funded Dependability, Innovation and Product Quality. It was technologies: The basic pattern envisioned is important to realize that good communication was to give institutions receiving public research critical for formulation and process transfer to be funds the right to obtain and exploit patents successful. on inventions developed in the course of Selection of method research. The method for batch fabrication was selected on the • Political stability and good transparent basis of data given from R&D. Granulation, blending, governance: A country’s relative political and compression and coating were critical parameters for economic stability will influence the rate of technology transfer. Technical information of inward technology transfer and can be seen developed products is obtained from data of a limited as a pre-condition for any technology amount of batches. Various standards have been transfer. Even when research-based established from the limited data and quality pharmaceutical company technology evaluation method established in development phase transfers are philanthropic in nature, they is not always sufficient for factory production. It is need to be sustainable in order to achieve highly desired to feed back and accumulate technical their goals. Political leadership is critical to information obtained from repeated address global and local health challenges Title must be in 24 pt Regular font. Author name and, more importantly, healthcare system must be in 11 pt Regular font. Author affiliation must capacity strengthening. be in 10 pt Italic. Email address must be in 9 pt • Research tool patents and freedom to operate Courier Regular font. for the public sector: Patents sometimes BARRIERS OF TECHNOLOGY TRANSFER make it difficult for public researchers to carry out their research or to make the • Lack of awareness knowledge and efficiency: products of that research available. It is Automation of production processes to intensified by the tendency of some publicly improve efficiency and lower costs. funded research laboratories to avoid use of a patented technology without permission even • Lack of government focus low market share: in nations where no relevant patent is in Local producers face significant challenges in force. meeting International Quality Standards and • Appropriate Capital Markets: For many capturing a critical market share. Greater governments seeking to expand technological market share would increase profitability capacity, attracting direct investment is very important, but there is also a question of • Web access and scientific publication: making the most of the spill over benefits of Limited access to scientific journals led to investment. This can reveal a need for enormous problems for developing nations adequate capital markets. Governments can scientists. also promote inward investment through tax • Cost of pre-qualification: There is benefit in meeting International Standards since it AU/2017/06/0001486 Page 3

Assignment on Technology Transfer- By Pankaj Paul Roll No -50 breaks and other forms of incentives necessary to realize quality of design of drugs during designed to encourage technology transfer, in manufacturing. The three primary considerations to be compliance with international trade rules. addressed during an effective technology transfer are • Alignment with Economic Development the plan, the persons involved, and the process. A plan Priorities: The finite or limited resources must be devised to organize the personnel and the available to governments imply that process steps. Once prepared, the plan must be measures taken to promote technology communicated to the involved parties in research, at transfer need to both be realistic and to fit the corporate level and at the production site. The with overall policy goals. A technology technology transfer does not mean one-time actions transfer policy dedicated to the creation of taken by the transferring party toward the transferred completely new types of economic activity party, but means continuous information exchange and one which is as complex and as highly between both the parties to maintain the product regulated as the pharmaceutical sector can manufacturing1,5. To assure the drug quality, it is present a much bigger challenge than desire to make sure that is what, when, and why building on a sector that already exist. information should be transferred to where and by • Co-operative research agreements: Global whom and how to transfer, then share knowledge and support for public sector research might be information of the technology transfer each other encouraged is through co-operative research between stake holders related to drug manufacturing. agreements designed to meet specific goals. It would seem more feasible to focus efforts ACKNOWLEDGEMENT on technologies of significant social benefit I would like to thank Mr. Subhasis Chakraboty Sir for to the developing nations. his special guidance and support. • Possible treaty on scientific access: There has also been a proposal for an international REFFERENCES treaty on access to knowledge and technology negotiated on the basis of the 1. Mahboudi M, Ananthan BR. Effective factors in technology type of reciprocity found in normal transfer in the Pharmaceutical industries of Iran: A Case international trade negotiations. The concept Study. The IUP Journal of Knowledge Management 2010; 8: is mean to be non- zero sums in the sense (1 & 2): 99. that, like free trade in goods, free trade in scientific ideas benefits all and such 2. Bendis R, Byler E. Creating a National Innovation arrangements could be made bilaterally as Framework, Building a Public-Private Support System to well as multilaterally. Encourage Innovation. Science progress 2009. DEVELOPMENT REPORT 3. Reamer A, Icerman L, Youtie J. Technology Transfer and The ultimate goal for successful technology transfer is Commercialization: Their Role in Economic Development to have documented evidences. The development 2003; 10-16. report contains data of pharmaceutical development of new drug substances and drug product at stages from 4. Feifei YUE, Yigming YUE. Research on Technology Transfer early development phase o finale application of in the Pharmaceutical Industry, Technology Transfer Journal approval, information of raw materials and of Tongji University. Natural Science 2008; 11-14. components, rational for dosage form and formula designs and design of manufacturing methods, change 5. Ghafaripour A. Fundamental Concepts for Technology in histories of important processes and control Transfer Process, Industries Ministry, Tehran 1999. parameters, stability profile, specification and test methods of drug substances, intermediates, 6. drug products, raw materials, 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. This report contained the method of development as well as process development. Process development and commercial production were on critical path because of compressed time-to market expectations. CONCLUSION In pharmaceutical industry, technology transfer means action to transfer of information and technologies AU/2017/06/0001486 Page 4