Online Event
Subvisible aggregates are a critical quality attribute (CQA) and a key measure of physical stability for all biologics. Aggregates are comprised of proteins that have coalesced into larger particles that can only be detected by specialized analytical techniques. They can arise at various development stages and compro mise the safety, efficacy, and stability of therapeutic biologics. To ensure the development of effective therapies with long shelf lives, these aggregates need to be accurately characterized