June 2022

Ask the Expert: Using High-Throughput Analytical Systems to Facilitate Binding-Kinetics Assays

Critical quality attributes (CQAs) must be characterized thoroughly to establish a biopharmaceutical’s potency, efficacy, and safety. Such characterization involves some of the most difficult analytical activities that are performed in a biologic’s product life cycle. There is great need for analytical tools that can facilitate such studies. In March 2022, Dr. Kalhari Silva (head of scientific research at Custom Biologics) and Dr. Bob Dass (senior scientist at Sartorius) joined BPI to describe how Octet biolayer interferometry (BLI) technology can be…

Managing Manufacturing Requirements for Live Biotherapeutics

In 2018, Synlogic explored options for producing clinical-trial material for its lead programs, including a candidate therapy for the rare metabolic disease phenylketonuria (PKU). Like other emerging drug developers, the company evaluated the merits of outsourcing manufacturing to third parties. However, Synlogic leverages synthetic biology tools to design and develop therapeutics based on genetically engineered microbes. Thus, it also needed to consider requirements specific to live biotherapeutics. Late in 2018, Synlogic announced plans to establish its own current good manufacturing…