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10 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m APIs Computer modelling has also allowed for an im- proved design of APIs (fitting them to the target molecule more specifically like 'lock and key'). These new design approaches improve the chances of success for the individual patient; however, they also make the target population much more frag- mented. For example, today, the target is no longer 'lung cancer,' but many different types of 'lung can- cer' that are now specified and targeted by differ- ent medications. As a result, the demand for API quantity is significantly reduced. APIs requiring more than a few metric tons a year are very rare; demand for most products will be in the range of hundreds of kilograms at maturity." Recommendations for partnering with an API manufacturer According to Grabowski, customers should find a CDMO that can partner with them to provide expe- rience, feedback, and guidance regarding IP, regulatory, quality, and/or supply chain concerns. However, for some prospective customers, the deciding factors for selecting an API manufacturer are the price tag and lead time, which Seekamp cautions against. "When companies are evaluating API manufactur- ers, they should be looking at more than just price and lead time, and [they] should be asking how the manufacturer responds to problems when they occur during manufacturing. Unexpected events can occur during the transition from the laboratory to the pro- duction plant, and how a company responds to those incidents separates a partnership development and manufacturing organization (PDMO) from a typical CDMO," Seekamp continues. "Acknowledgement and acceptance of the need for process changes by the cli- ent will greatly speed the timeline for onboarding the program, and [it] will allow the development teams to start working effectively. When clients resist proposed changes, significant amounts of time can be lost by the development team having to demonstrate why the process/analytical method needs amending. As time is typically the most critical aspect for a client, any steps that can be taken to accelerate the implementation of a process at a PDMO are beneficial to all parties." For Stanek, it's about striking a balance between speed, quality, and cost. "Even under pressure, companies must maintain their focus on balancing the triangle of 'speed, quality, and cost,' particularly if they expect to carry the project forward themselves," says Stanek. "Those looking to work with APIs should be cautious to not solely focus on good clinical results, which are the trigger for sell- ing off, but keep sustainability in mind as well, such as process robustness and crystallization. Companies must also educate their stakeholders about the bound- ary conditions in chemical API manufacturing. For example, APIs are usually manufactured in multi-step processes with each step being a manufacturing pro- cess of its own, which may include custom-made raw materials. This requires much longer manufacturing lead times than for drug products or even biologics (large molecule) APIs." In summary, there is nothing small about the chal- lenges and complexities confronting small-molecule API development and manufacturing, but from a mar- ket standpoint, they are on course for a very big future. References 1. Patheon by Thermo Fisher Scientific, "Small Molecule API Devel- opment," www.patheon.com/drug-development-services/small- molecule-api-development, accessed Sept. 16, 2021. 2. Market Research Future, Small Molecule API Market Research Re- port: Information, by Types (Synthetic/Chemical API and Biologi- cal API), Application (Cardiovascular, Oncology, Diabetes, Immu- nological Disorders and others), Manufacturing Method (In-House and Contract) and Region (North America, Europe, Asia-Pacific and the Middle East & Africa)–Forecast To 2027 (February 2021). 3. Data Bridge Market Research, Global Small Molecule API Market– Industry Trends and Forecast to 2028 (February 2021). PT