Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
Biologics manufacturing a complex procedure, and it takes time and effort.
While classical therapeutic small molecules are made by well-known organic or chemical synthesis with few critical steps, biologics (and biosimilars) are produced by living cells in a very complex process with several critical phases.
Moreover, the biological molecule itself is complex. Unlike small molecular drugs, whose structure is homogeneous and well characterized, biologics (and biosimilars) are less easily characterized because of their intrinsic heterogeneous nature (several physiological isoforms).
Precisely because biologics are produced in living cells, it is almost impossible to guarantee that each batch is identical to the previous one. In any case, manufacturers are required to have as much control over the process as possible to identify and manage unexpected variations which may affect product quality, efficacy, and safety.
Taking into account the specific nature of biologics, based on regulatory guidance and case studies, this course aims to explain the regulatory considerations for biologics and biosimilars manufacturing to obtain clinical trials and marketing authorizations in Europe. Among the vast world of biologics, we will focus on monoclonal antibodies, vaccines, and insulins.