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Technology Transfer In Pharmaceutical Industry
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Technology Transfer Challenges In Pharmaceutical Industry
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How Can We Improve The Transformation Success Rate Of Research Results In The Pharmaceutical Industry? The Game Theoretic Model Of Technology Transfer Subjects
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In the biormocese industry, technology transfer refers to the transfer of any process along with professional documentation and inspection, between development and production or between production sites (1). This operation is common in the bioformoceusal industry for several structural reasons. This includes dichotomy between small narcotics based on innovation and large, capable of clinical development of late phases and blessed with production power; High capital cost of biormocenic plants, making the contract attractive; And the need for several scales during the product life cycle.
“Technology transfer” is a fine business related to business, normative, product quality and technical risk. Basic principles are simple: Creators approve all their knowledge to provide products. Even in this basic reflection, some difficulties are shown: it is not a moving or duplicated physical asset, and the ability – something more difficult to determine, determine and correct. Both creators and recipients may need to overcome geography, organization, technical and more. Add to those who are concerned with the soft nature of bioformoceusal treatment, and the complexity of technology transmission: difficult for a particular task associated with its essence by the complex production process that may have several variations depending on the gap to be resolved.
Each case of delivery of technology is potentially different and requires a clear approach – or at least individuals. Below I classify what distinguishes one technique from another, and therefore potentially more complex. The determinants of such complexity have specific consequences for technology delivery projects, their critical success factors and risk management.
Technology Transfer In Pharmaceutical Industry
Many of these technology transfer projects are unique. They can be identified from different situations, and certain gaps that occur between the donor and the recipient. Table 1 contains differential factors, as well as examples and certain risk factors. Each factor is briefly explained below, and several factors receive more detailed discussions in the following sections.
The clear complexity determines is how many production chains are sent: from one item (such as filling the product and the completion of the drug) to the entire process (from the production of cellular banks to the final drug, with all related tests). The amount of transfer up to a certain point is management management with operating and strategic elements. The higher the volume, the harder the delivery is. Difficulty increases more when different parts (such as drugs, drugs and analysis) are transferred from or to different sites.
Some processes have more complexity than others. Although we automatically think about the process itself, including unreasonable steps and unusual units, other causes cannot be forgotten. Difficulties can contact fine or complex molecules, compact features, raw materials that are difficult to qualify, or complex analysis packages. The latter should be noted, as during technology transfer, it can appear napobust even for standard methods, such as detecting host cells with the help of immunosorbent analysis (ELISA). And many potential methods, especially in cellular analysis, have problems for delivery due to high variability. For example, the transfer of analysis packages for cell therapy is not trivial. The ability to process the complexity of congenital production in all dimensions is a critical factor for site choices.
Changes during technology transfer are tempting and normal, but they require careful management of quality, regulatory and technical prospects. If nothing has changed, the technology translation will be reduced to training, so the type and level of change is a clear complexity. Case with change is considered below. It provides the same approach as the congenital complexity, so one discussion can cover another.
Scale Up And Technology Transfer In Pharmaceutical Industry
The level of product life cycle is an important differentiation between technology delivery projects. Two opposite trends are associated with it. On the one hand, the more products are moving through its clinical program, the higher the regulatory expectations during the transfer, increasing the complexity of the project. On the other hand, more
The process of process technology is largely related to the clinical phase of the project (through technical development and production experience). But in this clinical phase, the understanding of the creator is very different between the projects. Eligibility and inspection analysis is also far from the standard for projects. Such factors interact with the complexity of the existing process. The delivery of complex processes is more risky than normal if it is quite insufficient for its clinical phase.
The maturity of site entry can be measured by its experience with the same translation, degree and depth of its quality system, normative experience and strength support (for example, for development, support, analysis, project management and check). Acceptable maturity on this site must be in accordance with the delivery to be met. However, you should support the balance with the creator site.
Such an opinion leads to the comparison of the creator and the acceptance of the site and determines cultural differences as a source of complexity. See more than geographical or linguistic differences, although these differences cause a clear problem.
Risk And Knowledge Management As United Enablers
Finally, a contract agreement can affect the delivery of technology. Usually, the contract transfer project is transferred as a work package. While difficult budgets and terms can lead to effective and creative solutions, they usually give excessive tensions to the delivery team, damage the long and recurrent relationship, and complete the check. The quality agreement must be accepted as soon as possible during the transfer. Treatment of change and deviation is part of each gear, and needs to determine the shared approach. Finally, the delivery of technology is a project set, but eventually rarely: its success criteria must be allowed by the long -term production agreement.
The need for technology transfer can occur throughout the product life cycle: from the first transfer of development to the production of good production practices (GMP) to the end of life to the object with a low basis. It is important to understand that technology transfer always has significant normative consequences.
Early transfer to GMP corresponds to a new investigation of the drug (Ind) and/or investigation of the drug product daser (IMPD) by setting the tone for the entire project. Subsequently, the regulatory organs believe that every transfer of technology is a major change (except for some special cases). Unlike chemical formation, there is no regulatory tolerance for “in 10 times changes in the scale” for bioformoceus. Even without clear change, authorities are careful about new production sites as they usually have different quality control systems. Transmissions always come with some “hidden” changes and often require training staff in new processes.
The main problem is product comparison. The regulator expects the product made to the recipient’s place to be clinically compared to the product made at the appropriate creator site – and the comparison will be shown (2).
Technology Transfer In Pharmaceutical Industry: Anurag Sharma M.pharm (pharmac Eutics)
There are several effects here. For the first time, the establishment of a comparison is part of the delivery of technology. Second, the severity of the comparison increased with the clinical experience. Relative is not important when moving from development to GMP, comparisons are demanding commercial levels, which may require a large set of production data.
Third, specifications are usually inadequate to establish comparisons. For example, if the specifications are broad compared to accuracy, data from both sites may vary statistically while still in specifications. These concerns may be, or may not have clinical consequences, but the creator must resolve the difference. Rounds also require more than release analysis, with additional features and stability (preferably accelerated or tense).
Fourth, when the analysis method is transmitted, it is necessary to indicate that they provide equivalent results. These requirements must be included in the delivery of the analysis method, and the faster it is done in the general program, the better.
The need for
