Current Issue

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.

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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.

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Analytical

Particulate Contamination in Single-Use Systems: Challenges of Detection, Measurement, and Continuous Improvement

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…

Achieving Consistent Performance by Managing Raw Material Variability Through Predictive Modeling

The past 30 years have brought significant progress in the design and manufacture of cell culture media as well as in the types of components used. With these advances, the biopharmaceutical industry improved its processes — from producing just a few milligrams of product per liter of culture to ≥10 g/L. Since the early days of microbiology, peptones have been used widely as a basic ingredient of microbial media. In the 1990s, peptones were introduced as a substitute for serum…

Collaborate to Innovate: Shaping the Future Pharmaceutical Manufacturing Landscape

As the demand for new life-enhancing therapies increases globally, the pharmaceutical manufacturing community faces an unprecedented challenge to accelerate speed to market. Keeping up to date on industry trends is critical to maintaining a competitive edge. But how do you actively drive these trends and apply them to your manufacturing processes to bring your innovation strategy to life? Whether you are implementing single-use technologies to reduce costs and increase productivity or expanding your operations in emerging markets, scientific collaboration and…