Current GMP milestones
Throughout the stage of development of a mAb product, production quantities differ, starting with micrograms to grams for research and toxicology studies, to tens to a few hundred grams for early-stage clinical studies, to up to hundreds of kilograms for late-stage clinicals trials and licensed production (Carson, 2005). Manufacturing facilities must therefore suit the needs and requirements of production throughout clinical development. As the resulting DP from downstream processing is ready to be administered into patients, precautions and regulations must be taken and followed to assure product quality, safety, traceability and reproducibility. Regulatory health authorities such as World Health Organization (WHO), FDA and EMA have described and constantly audit the so-called current Good Manufacturing Practices (cGMP). GMP outlines measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed and documented. By these definitions, products are ensured to be produced and controlled according to quality standards appropriate for their intended use and as required by product specification. Manufacturers and their facilities located in the European Economic Area (EEA) must hold authorization issued by a national competent authority and must comply with European Union (EU) GMP to obtain authorization. The national authorities are then responsible to inspect manufacturing sites and ensure they are effectively following the EU GMP guidelines (European Medicines Agency, 2016). The GMP guidelines are based on the following principles (WHO, 1998):
With the strict implementation and control of GMP, the drug product is guaranteed to be safe and traceable. Deviations and variations can be easily tracked, and action can be taken accordingly to avoid putting the patient at risk or losing drug efficacy throughout the process.