August - 20199MANUFACTURINGTECHNOLOGYINSIGHTSprocurement and management, intermediate products, finished product shelf life considerations, and special storage conditions. When responding to information requests from CMOs, you may not have all of the answers. While you should aim to provide as much insight as you can, most CMOs have access to a variety of experts who will aid in determining your final product and process requirements. What a CMO's experts cannot do is help prevent the development pitfalls that happen before you come to them. Avoid pitfallsPinpointing inefficiencies during prototyping is often tricky. Be aware of the following pitfalls early to help prevent unnecessary challenges and delays: 1. Believing product design is frozen. CMOs can provide critical feedback that can drive the process or even product design changes for several reasons, including regulatory considerations, functionality, and production. It is essential to approach these conversations with an open mind. 2. Trying to please everyone. While product feedback is vital, especially during clinical trials, your initial design likely won't fit the needs of every customer. Making changes to product or process post clinical builds will delay your launch and add cost.Choose appropriate tradeoffs.3. Testing too soon. If you make changes or do too much validation on the front-end, it will likely lead to additional justification of those changes and retesting. 4. Setting the qualification bar too high. Trying to accomplish a level of performance beyond what is necessary can waste vital time and resources. It could even lead to a failed market launch if early tests had passed with more reasonable ­ and still acceptable ­ requirements.How to vet a CMOIt can be challenging to know precisely what is needed from a CMO before working with them, but discussing the following topics will help determine if they will be the right partner. Some critical issues related to purchasing power, partner relations, in-house capabilities, and regulatory expertise. A CMO with reliable purchasing power can negotiate fair prices and consistent supplies. If a CMO uses a disproportionately high amount of single or sole-source suppliers, they may not have the needed leverage to maintain a high-quality, regular supply chain at a reasonable cost.Partnerships are a vital part of CMO's service offerings. Inquire about previous projects to understand their responsiveness. Asking about relations with their shipping and sterilization partners can help to understand existing agreements. Considering a full-service CMO, with testing, licenses, certificates, and risk assessment services, can minimize inconsistencies, errors, and "finger pointing." If the in-house capabilities of a CMO are not expansive, at a minimum, ensure they have strong partnerships, so they can assist you in filling any of your program gaps. As you ask questions about their capacity, you will want to know if they outsource boosts to subcontractors or if they manage those internally. A highly knowledgeable CMO understands the regulatory landscape and validation process to help educate and support you through manufacturing and approvals. They also should clearly define the scope of the project and delineate responsibility for critical steps.You can avoid method transfer traps and headaches with careful planning and partnership. Being collaborative and asking the right questions will go a long way toward a successful manufacturing experience with a CMO and ultimately, a high product launch. A highly knowledgeable CMO understands the regulatory landscape and validation process to help educate and support you through manufacturing and approvals
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