August 20198 MANUFACTURINGTECHNOLOGYINSIGHTSIN MY OPINIONMethod transfers are integral to getting a product to the manufacturing floor. The transition of information and processes from an original equipment manufacturer (OEM) to a contract manufacturing organization (CMO) may seem mundane, but a smooth method transfer requires a significant amount of detailed work and collaboration. Success in taking a product from prototype to manufacturing and ultimately to market will depend on thoughtful planning, partnership, and attention to detail. Knowing what a manufacturing partner will need from you, what pitfalls to watch for and how to vet CMOs will help you with the transfer. What a CMO will need from youCMOs gauge your readiness for a product launch based on how well your product and process are defined and how knowledgeable you are about launching a product to the market. Your depth of knowledge and preparedness for this information exchange can save you significant time and money. Here are a few categories of questions to consider: Regulatory approvalGauging regulatory pathways and the approval process helps understand your testing and validation needs, the product and process manufacturing requirements, and which markets and regulatory bodies are in play.Product information CMOs will ask for every detail available about your product including predicate products, performance requirements, packaging, labeling, release testing, shipping, and any unique raw materials, such as biologics and tissues.Process progressSimilar to product information, CMOs will need any details about your production process. They will ask for an overview of any special equipment needs, target lot size, sterilization, material By Cory Nelson, Assoc Director of Contract Manufacturing and Continuous Improvement, WuXiAppTecManaging a method transfer: How to achieve a smooth transition to manufacturing
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