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Drug Manufacturing Processes

Vaishnavi Reddy

February 28, 2021

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The pharmaceutical industry spends almost $150 Billion every year globally on the research and development of drugs, but the sales and profits don’t reflect similar numbers as they are on a decline year on year. The drug manufacturers are creating continuous, modular, and scalable processes to fast track innovation and solve cost and quality challenges. Many large-scale companies are shifting their drug production to contract manufacturing and contract developmental organizations to fill the operational capacities and profit and expertise gaps. According to Results Healthcare, the level of outsourcing in the USA concerning drug manufacturing stands at 24.6% and is expected to rise to over 26% by 2021.

With differing expectations in terms of responsibilities, timelines, and budgets, the companies and their contracting organizations are always in conflict. There is a considerable amount of delay during a project transfer, as it calls for multiple agreements specifying the roles of each of the parties involved. The agreements include procedures and permissions to set product specifications, manufacturing records and amendments, approval, and release of materials, rework systems and deviations and responsibilities of customer complaints. Every party involved in drug production is required to practice GMP and other compliance activities mandated by regulatory frameworks such as well-defined SOPs, external production log reviews, laboratory controls, sanitization and maintenance, GMP training, and many more.

Furthermore, this industry is also known for its complex supply chains, which are now being rapidly digitalized to promote automation. Research shows that companies that have incorporated automation and digitalization of their supply chains have boosted their revenue by 9%, market valuation by 12%, and profitability by over 26%. Supply chains entail suppliers from multiple locations and of different sources that are subjected to various regulatory frameworks. Hence, the companies look to integrate all their supply partners under a virtual network where all the players have constant access to emerging technologies that enable aligned performance management, internal and external collaboration, flexible production, and dynamic sourcing and processing at every step of manufacturing. They also wish to engage all their partners in smart warehouse management and transportation systems by implementing temperature-controlled logistics, labelling, and packaging procedures, extracting review data, and tracking quality metrics by utilizing industry IOT to ensure overall compliance.

Virtual engineering has catalysed not only the validation of new process design approvals but also enabled fast reconfiguration of manufacturing lines with modular components for different drugs. It has also helped reduce costs by allowing more straightforward and quicker modification of supply chains for each process type and management of shifts and step changes associated with live licensing. Additionally, Continuous manufacturing has taken over batch manufacturing in recent years, eliminating the need for offline quality testing and shipping and hold times as it moves non-stop within a single facility through an assembly line of fully integrated technologies. CM helps manufacturers obtain end-to-end traceability, detailed analysis of each process, access to real-time equipment monitoring, and product tracking.

This increase in data aggregation has given rise to companies’ ability to formulate demand and inventory forecasts, thereby facilitating effective tender management and secondary production planning and scheduling. Similarly, these players also acquire active ingredients and design/modify plant equipment and storage systems according to the changing demands. Such pipeline management can be successful only when backed by extensive research and analyses of processing times and probabilities, resource requirements, market returns, task sequencing, vendor networks, etc. of similar products produced in the past under various regulatory bodies.

To achieve better corporate financial performance, many pharmaceutical companies are pursuing Corporate Social Responsibility (CSR strategies). Companies are altering their processes to minimize waste and emission generation, water and energy usage, and consumption of raw materials via repurposing, serialization, etc. Moreover, they are offering affordable pricing, enhanced quality of supply chain and drug distribution, healthy collaboration with local governments, safe R & D practices, high stakeholder satisfaction, and overall annual reporting to its stakeholders compliant with GRI (Good Reporting Index). As perceptions of integrity and reputation are often closely related to pharmaceutical brands’ success, drug manufacturers establish transparency by clinical data with third parties to promote social R & D and demonstrate the legitimacy of collaboration with various representatives of the healthcare system. They are also leveraging big data and implementing continuous readiness models to reduce the cost of audits and inspections, engaging with regulators to emphasize quality culture and ethical behaviour as Mitigating compliance risks not only helps companies avoid fines, remediation costs, and reputational damage, it ensures the sustainability of the pharmaceutical industry.

Subtl can act as a reliable partner for all document intelligence needs at every step of the drug manufacturing process. It can bolster knowledge access in the much needed virtual network amongst all the parties involved in the supply chain and processing by eliminating confusion and delay of information transfer amongst employees of different sectors. Subtl provides a platform to have confidential clinical information that can be custom shared to each of the parties whenever requested, will understand data of various types both structured and unstructured, and respond to queries posted by the users. As the pharmaceutical industry moves more towards compliance, reporting, and data collection, Subtl can be embedded in each of these areas, thereby fostering interdepartmental collaboration and entirely eliminating delays at every micro-step. It can be used by the engineers in easily retrieving experimental and past process data to design and reconfigure manufacturing lines quick enough to accommodate changing orders, subsequently improving the asset utilization rates. Additionally, it can be used to make more dynamic and accurate forecasts of active/secondary ingredient demands, production planning, and scheduling per changing market trends and help achieve the profitability and reputation every pharmaceutical company aims to.

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Vaishnavi Reddy

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