Let’s face it, the BioPhorum Operations Group (BPOG) extraction protocol for Biopharmaceutical Single Use Systems stinks (professionalism prevents a stronger expletive). The protocol is labor intensive, presents multiple analytical challenges and can be expensive. Unfortunately, it is not optional. If manufacturers of single-use components want to sell their products into the biopharmaceutical and biotech industries, they must perform the BPOG extraction protocol. The biopharmaceutical and biotech customers (and their regulators) will be expecting it.
To help a manufacturer of single-use components prepare to execute the BPOG extraction protocol, below are the answers to four common questions.
Pine Lake Laboratories is a GLP/GMP compliant analytical and bioanalytical contract testing laboratory. Our lab, located in Bristol, CT, is FDA registered and inspected and DEA licensed for Schedules 1 through V.
