If the same vendor is used, ideally, the physical characteristics of RUO-grade raw materials would be the same as GMP-grade. They would differ only in robust documentation, such as Quality Assurance personnel performing final review and approval of batch documentation, and formal validation conducted for GMP products. There should also be extensive safety testing of raw materials that might come into contact with patients. It is fair to ask a vendor whether the manufacturing processes are the same for RUO and GMP raw materials.
If clinical applications are the goal, it is suggested that the switch to GMP be made early. Even during preclinical stages if possible. It is far easier to do equivalency testing early in product development than during later stages when changes can be costly and time-consuming.
Choosing a vendor with experience can also be advantageous. This can mean having a good understanding of quality management systems, protein biochemistry, and analytical testing methods. In addition, experience in regulatory matters is key. An experienced vendor can help when navigating changing regulatory landscapes. Availability of Drug Master Files (DMF) that contain detailed information about the raw material can assist regulatory authorities and ease investigational new drug (IND) applications. If possible, audits of vendor facilities should be conducted, and virtual audits should be made available for those that canít be done in person. The relationship between vendor and customer needs to be a partnership, and experience counts.
A minimum of three consecutive lots are manufactured, tested, and released in accordance with approved standard operating procedures to meet pre-determined acceptance criteria. (The Quality Control department is responsible for final review and approval of RUO products). For products that were developed with RUO raw materials, there may have been modifications in the manufacturing process and/or final product testing which are applicable to the GMP product. In this case, it is advisable that the GMP product is used for any ex vivo clinical studies.