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MedTech Outlook | Friday, November 04, 2022
Pharmaceutical companies benefit from emerging technologies and disruptive manufacturing concepts.
FREMONT, CA: The pharmaceutical industry's speed of discovery and development has accelerated in recent years, with shorter development timelines and more medicines introduced than ever before. A recent example is RNA-based vaccinations and RNA-based therapeutics, which emerged in response to the pandemic. On the other hand, new treatment methods and active ingredients frequently present new obstacles, necessitating the development of new formulation methods and technologies to satisfy this demand.
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There is a general trend for advanced manufacturing technologies in the pharmaceutical industry, with a strong emphasis on connected and more efficient processes, such as continuous manufacturing, new technologies suitable for personalized and on-demand medicine (such as 3D printing), and an ongoing effort to provide solutions for complex compounds in the pipeline (such as solubility enhancement approaches). Modeling, predictive techniques, and digital collaboration are on the rise in the pharmaceutical sector due to digitalization, difficult chemicals, and a rapid pace. In addition, the growing quantity of biomolecules in development presents additional and distinct difficulties, such as protein purification and stability.
TRENDS TO ALTER THE PHARMACEUTICAL LANDSCAPE AND OFFER INTRIGUING PROSPECTS FOR FUTURE TREATMENTS
Continuous Production and Transition from Powder to Tablet: Tablets are a basic and common dose form. Patient compliance and ease of self-administration also contribute to their allure, as do the benefits of handling, shipping, and storage. Currently, most tablets are produced through a sophisticated, multistep process known as batch production. Each phase, blending, tableting, and coating, is conducted independently, followed by a quality inspection and possible storage or shipment processes. This lack of flexibility and agility may represent a risk to the healthcare system. The FDA supports a paradigm change from traditional batch production to continuous manufacturing (CM) of medicinal products. The method refers to the continuous feeding of starting materials (i.e., APIs and excipients) to the solid dosage (e.g., tablet) manufacturing line. At the same time, the end product is continually removed from the system with online and real-time quality monitoring. This procedure is referred to as "powder to a tablet."
For instance, in 2016, the FDA permitted Johnson & Johnson (J&J)/Janssen to convert from batch production to continuous manufacture of the medication Prezista, which is a landmark move. With this change, J&J/Janssen lowered manufacturing and testing cycle time by 80 percent, reduced waste by 33 percent, and consolidated seven rooms into two.
These advantages include securing supply chains, improving product quality, and ensuring a more efficient and expedited process from development to commercialization. New requirements for equipment and skills, together with the process as a whole, provide difficulties.
These obstacles are in addition to the requirement for particular properties in the raw materials that did not exist in batch processing. The ICH Q13 draft guideline defines two critical quality attributes (CQAs) for the raw material. Blend and content homogeneity were evaluated by determining the major excipient's bulk density and the drug component's particle size distribution.
Continuous manufacturing equipment consists of loss-in-weight feeders for excipients and APIs, a continuous blender to mix raw materials, and a rotating tablet press for lubricants. This is expandable to include additional dry or wet granulation units and a coater. If the material, particularly the excipient, aggregates, flows poorly or exhibits triboelectric tendencies, process disruptions are likely to arise during feeding. Low-dose API formulations can provide difficulties with homogeneity during blending. Applying the proper excipients will ensure a smooth and robust procedure. Applying the proper excipients will ensure a smooth and robust procedure. When choosing a continuous manufacturing setup, you can implement the quality by design (QbD) approach by understanding the critical material attributes (CMA), focusing on the critical quality attributes (CQA), understanding the critical process parameters, and implementing a control strategy that ensures a robust process and provides an environment for continuous improvement.
Quality standards can also be maintained using this QbD method. A continuous production process allows for quality assurance principles, such as real-time release testing, to be incorporated. This process uses process analytical technology to monitor product quality throughout the process, eliminating the need for laboratory testing. This ensures that the intended quality is maintained throughout the entire process.
Continuous manufacturing paves the way for simple tablet production and presents many advantages and problems. It will be fascinating to observe the extent to which regulatory agencies continue to encourage this future trend.
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