How does agent type affect biologics production?
For almost all biologic agents, production centers around the cell. Molecule-based biologics are produced using cellular factors, the cells are the agents themselves for cell-based biologics, and tissue-based biologics require multiple cells to associate and interact with each other in the desired manner. Cell culture is therefore integral to biologics production.
However, the ideal culture conditions will vary depending not only on the type of biologic agent being produced, but also the nature of the cells themselves. For example, growth-promoting substances are integral for promoting tissue formation, and are useful for increasing cell density – and therefore yield – but care has to be taken to prevent overcrowding and uncontrolled growth.
Scientists working with molecular-based biologics will need to pay close attention to the characteristics of the harvested final product (i.e., size, conformation), as any variation can have significant impacts on efficacy and side effects. As such, particle screening and analytical ultracentrifugation are more important techniques for researchers working with molecule-based biologics than those working with tissue-based agents.
Scientists working with cell-based biologic agents need to not only carefully monitor physical properties, but also phenotypic characteristics. The former can be accomplished using a cell counter, while the latter is most commonly executed by using flow cytometry to capture surface marker expression profiles.