In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and the main manufacturing challenges involving highly potent APIs.
Read Part I: HPAPI Market Forecasts and Manufacturing Challenges
As demand for contract development and manufacturing of HPAPIs continues to increase from both new and existing relationships, it is important to anticipate and proactively expand to meet those needs. At Alcami, current market trends and our small molecule expertise drive our strategy to continue to invest in new capacity and expand our capabilities within this submarket.
Production capacity is multiplying as companies recognize the growth potential in this submarket. However, the high-cost barrier to entry continues to limit who invests and how far organizations are able to expand. While the infrastructure and equipment is a key component in creating capacity, the industry is still underserved in expertise. As physical investments grow, the effectiveness of those assets is still lagging behind; more is needed than merely an isolator and an idea to successfully develop and manufacture an HPAPI.
Any good engineering project begins with the creation of a User Requirement Specification (URS). It helps to ensure the end user ultimately gets the capabilities and controls they desire. In the most recent HPAPI production expansion at Alcami’s Germantown facility, it became clear during development of the URS that a traditional “put everything in an isolator” approach was not going to be feasible while still delivering the maximum range of scale and capabilities desired. As detailed engineering progressed, the design evolved towards strong, multi-layered facility controls coupled with a more modular equipment design delivering maximum facility flexibility to meet the requirements for chemistry, scale, containment, and future expansion.
Customers have complex chemistries and diverse therapeutics indications; anticipation of their specific needs, even if not required in the current portfolio, meant including capabilities such as hydrogenation and cryogenic reactors. Doing so in a modular and portable platform then afforded flexibility in the future to go beyond what was initially anticipated . This enables tailoring the equipment to the process and not the process to the equipment. That means the best process design can be selected, not just the best that could be made to fit, ultimately better leveraging an organization’s expertise in process design.
Thank you for your interest in learning more about the HPAPI industry. At Alcami, we are committed to offering our clients state-of-the-art HPAPI development and manufacturing facilities. Connect with our industry experts to achieve the best outcome for your product at every level.
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