The Food and Drug Administration (FDA)’s (cGMP) official regulations on the design, oversight, management, and upkeep of manufacturing processes and facilities are known as “current good manufacturing practice” (cGMP) in the United States. Pharmaceutical and biotechnology businesses adhere to cGMPs to make sure that their goods match a number of specifications, including those for qualities, purity, and strength. The FDA regulates compliance. There are numerous federal regulations pertaining to cGMP production; breaking any of them will result in criminal consequences.
The manufacturing staff at Creative Biolabs is skilled and knowledgeable, and the lab apparatus is routinely verified and inspected to ensure strict adherence to cGMP. Daily environmental monitoring shows microbiological and particle management in the production area and assures compliance with the proper room classification. Additionally, quality control staff frequently check batch data, processes, and procedures.
The products for antibody characterization at Creative Biolabs relate to both quality control in fundamental research as well as the commercial elements of therapeutic antibody pharmacokinetics. The technical materials listed below are comprehensive and can be used to characterize antibodies.