In our last post, we discussed what you should consider when selecting a CDMO partner to develop API for pharmaceutical clinical supplies. After selecting a CDMO, there are strategies you should follow to ensure a successful partnership with your new CDMO.
When entering into a partnership with a small molecule API CDMO, it is important for drug sponsors to develop a strategy with a reasonable timeline, and negotiate expectations as much as possible upfront, before the work begins. Setting the right expectations can be easier with a Request for Proposal (RFP). It typically accelerates the outsourcing process by helping align the customer and the manufacturer, with little room for miscommunications or misunderstandings.
An experienced CDMO will offer valuable advice during the RFP process, helping the sponsor as they set their objectives and connect to the downstream drug product and clinical study stakeholders. Done correctly, work on the front-end of API development can accelerate the downstream drug product supply as some of the solid-state impurities and physical characteristics can be optimized during API development. Some of this information may prove useful to further protect intellectual property (IP) of the sponsor and a good CDMO can advise on ways to generate useful IP related information.
It’s also important to note that when drug development is more complicated than normal, or if a molecule is being synthesized for the first time, issues are bound to arise. Choosing a CDMO that can work through and complete all tasks despite these, and other obstacles, is key. The sponsor and CDMO should constantly communicate and align on a common understanding of what can be expected, especially related to timing.
Some projects may take as little as 3-6 months to go from concept and business negotiation to GMP supply, depending on the capacity of the CDMO and the complexity of the project, while more complex projects could take several years. Sponsors should be prepared that timelines could shift over the course of a development project; however, a good CDMO will communicate these shifts openly and in a timely manner, while also thinking about ways to bridge the project plan back to its original timeline. In these cases, the sponsors and CDMO must communicate well and work together to constructively solve the problem, while managing expectations from internal stakeholders.
Safety and environmental compliance are crucial in small molecule API development, and it is critical to discuss these aspects during the RFP stage to ensure the CDMO has the necessary capabilities, policies, and practices in place to meet the sponsor’s requirements. This includes assessing any required capital investment for safe handling. For instance, permits may be necessary for specific solvents or substances. Additionally, certain CDMOs may have restrictions on performing certain chemistries or hazardous reactions. Establishing a clear understanding of all manufacturing aspects early on fosters trust and sets the project on the right track.
Sponsors may also need to confirm lab certifications that they feel are important for the CDMO to have, such as ISO accreditation, which demonstrates quality compliance with international standards. Not all CDMOs are required to have ISO certifications, but by employing a CDMO that has ISO accreditation and that is also FDA-inspected, a sponsor can have a greater degree of confidence in the work-product generated by the CDMO partner.
Purisys has two global ISO certifications: ISO 17025 (Testing and Calibration Laboratories) and ISO 17034 (Reference APIs Producers). These certifications support Purisys’ analytical laboratories and reference standard program, further ensuring the quality of its services, and the purity and potency of the products it generates.
Although outsourcing the manufacture of clinical trial APIs is gaining popularity and becoming more common, choosing the right CDMO partner can be a daunting task. Sponsors should carefully consider factors such as the level of client focus and engagement, capacity and quality of technical capabilities (including expertise in the specific therapeutic area of interest), and experience with regulatory support. Once a partner is chosen and the business is negotiated, both parties must work together to set expectations upfront and navigate the process with flexibility.
Take the next step towards a successful outsourcing partnership by contacting Purisys today. As a reputable CDMO with expertise in small molecule API development, we can provide the client focus, technical capabilities, and regulatory support you need. Let us help you optimize your clinical trial APIs and achieve your research and development goals.