Summary: Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability...

Summary: Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities...

Summary: The creation of a reliable bioassay requires dependable master and working analytical cell banks. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., principal scientist at Catalent Biologics, explains...

Summary: As the biologics industry continues to grow, biopharmaceutical companies are evaluating continuous processing as a potential means to improve efficiencies. There are many factors to consider when determining whether continuous processing should be adopted, and if so, what adoption strategy should be used...

Summary: Antibody drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development...

Summary: Bringing a new biologic drug to the market is a long and expensive process with R&D cycles that can span more than 15 years and cost over a billion dollars. Nonetheless the pharma industry is increasingly shifting efforts to focus on these types of compounds...

Summary: Bioconjugates are an emerging class of biologics that combine the favorable properties of proteins, such as specificity and the ability to target distinct protein interfaces, with the advantages of synthetic small molecules, such as potency, bioavailability, and synthetic tractability. Early examples of bioconjugates include proteins linked to...

Summary: To further our aim of synthesizing aldehyde-tagged proteins for research and biotechnology applications, we developed methods for recombinant production of aerobic formylglycinegenerating enzyme (FGE) in good yield...

Summary: Antibody-drug conjugates have provided a breakthrough in targeted medicines but ways of increasing their stability and efficacy are still required. Historically, the technologies used to build these two approved products result in a heterogeneous milieu of conjugates...

Summary: Viral clearance studies are mandated prior to entering clinical trials and for the commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses.