Biologic drugs are manufactured in living systems or extracted from biologic sources. As the understanding of the molecular and genetic bases of disease increase, biologics often make use of new technologies to harness scientific progress – monoclonal antibodies, antisense therapies or recombinant fusion proteins.
Most biologics are complex molecular entities, difficult to fully characterize by existing science. This is why biologic products are often characterized by their manufacturing processes, which are likewise complex and very sensitive to changes. Slight changes in manufacturing conditions may induce potential changes in the biologic drug quality attributes with potential effect on safety and efficacy in patients. Hence, solid analytical tools, and thorough comparability assessment that may include further clinical testing are often required to demonstrate safety, purity and potency throughout development.
Backed by a growing corporate venture investment and driven by a large pipeline of monoclonal antibodies and vaccines under development, the global biologics market is predicted to double within the next 5 years.
Key challenges encompass:
- Identification and management of product-specific risks
- Overall Chemistry, Manufacturing and Controls (CMC) strategy
- Assessment of quality and implementation of the appropriate analytical tools (including potency assessment)
- Manufacturing processes and analytical methodology development/validation
- Viral safety evaluation
- Manufacturing reproducibility, scale-up and comparability assessment
- Safety profile – especially immunogenicity and viral safety evaluation
- Extrapolation of animal data to design First-in-Human clinical studies
- Market access strategy and value demonstration to payers