HPAPI Market: Opportunities and Challenges
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Growing opportunities for CMOs and CDMOs:
A comprehensive HPAPI manufacturing facility requires extensive planning, the use of risk management and assessment tools, and a mechanism to determine which compounds are suitable for manufacturing in a given facility. The production of such compounds poses hazards and risks to workers and the environment. Pharmaceutical manufacturers also need to have the capacity for the safe production, storage, and transport of a growing range of potent compounds. This makes it evident that implementing a successful HPAPI manufacturing strategy requires significant time and investment.
Hence, various sponsor companies prefer going to CMOs and CDMOs for assistance with the development, manufacturing, and distribution of HPAPIs and their formulated drug products as many of these companies have the necessary equipment. In the last few years, a large number of contract CMOs have expanded their HPAPI capacities to leverage this opportunity.
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How is need for appropriate process designs a challenge?
Process designs are one of the most vital requirements for HPAPI production operations. Most HPAPI and ADC drug payloads need to be produced in small clinical and commercial quantities. However, the production of gram-scale GMP APIs and payloads is challenging. Maintaining containment control when using flexible and small equipment, including glass equipment, is a definite challenge and requires an approach that is tailored for each process and unit operation. It is also important to maintain appropriate process designs at the developmental scale to ensure that the process fits the equipment and capabilities of the facility upon scale-up.
Furthermore, industry wide, there is an ambiguity regarding the classification of HPAPIs. Different pharmaceutical companies often have proprietary systems and the classification of new APIs is unknown due to lack of data. These issues can be overcome with appropriate process designs and containment controls, which a majority of company’s lack. All these factors collectively are likely to present a significant challenge for players in the HPAPIs market.
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Mr. Shelly Singh
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