The October issue downstream processing theme explores downstream process development with articles on endotoxin removal, viral vector particle analysis, host-cell protein (HCP) platform assays, and differential scanning calorimetry. Particulate contamination in single-use systems and continuous biomanufacturing are explored in our Focus On and Elucidation articles.
FEATURED REPORT: Emerging Therapies
According to a 2017 industry report, 74% of biopharmaceuticals currently in development (phase 1–3) are possible first-in-class medicines. They include regenerative medicines, conjugated monoclonal antibodies (MAbs), and DNA and RNA therapeutics. Some emerging therapies have been more at the forefront of discussions than others, but all are poised to bring exciting changes to patient care. Authors and experts in this Featured Report discuss how meeting and optimizing specific process needs for those products will be imperative to keep pace with innovation.
Patients receiving particulate contamination through parenteral delivery of biopharmaceuticals presents a significant potential health risk. However, the severity of that risk often is unclear. It depends on the route of administration, dosage volume administered, particle properties and amount received, and the ultimate fate of particles within a patient’s body (1). The appearance of particulate contamination also can be a visible indicator of product quality. Consequently, when such contamination is discovered within biopharmaceutical manufacturing operations, often it triggers costly investigations and…