Cell-based therapies are a challenge to regulators because they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro, and then administering in some form the expanded cells population back into the patient.
The tendency for most biological products to self-associate and aggregate, often irreversibly, is a considerable challenge in process management and design, as aggregated product leads to patient safety concerns, process challenges and lost yield. Therefore, it is important to reduce the aggregation of the biological product during processing and to remove aggregates efficiently and effectively.
In this webinar, academic and industry experts present several case studies that illustrate how novel lipid formulation strategies.
In this webinar, experts review the physiological changes of gut diseases and discuss how formulation approaches can potentially enable local delivery of macromolecule drugs orally with case studies.
The Webinar will focus on what should be considered in order to make the best choice to develop one given biosimilar instead of another and also consider the requirements to be successful in delivering such a biosimilar on the market.