This week’s headlines include: New Ebola Vaccine Gives 100 Percent Protection, Cancer-Free: One Recovery Inspires Another — and Could Help Thousands, Roche’s emicizumab haemophilia drug succeeds in trial, MaxCyte Collaborates with Washington University on Immunotherapy, 2017 shaping up to be pivotal year for CAR-T and CRISPR therapies, and Clovis’s ovarian cancer drug wins accelerated FDA approval.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:Cell Culture Basics Virtual Lab. The virtual lab is part of Thermo Fisher Scientific’s Gibco™ Education series.
Cool Tool – SCOUT® technology reduces time to market and increases chance of success for biopharmaceutical products Only 1 out of each 50 biopharmaceutical new product candidates makes it through the research phase into clinical trial testing and subsequently to the market. This high attrition rate is predominantly in the early development phases and is attributed to (I) undesired pharmacokinetics profile (39%), (II) lack of efficacy (30%), (III) in vivo toxicity in preclinical model (11%), (IV) adverse effect in humans (10%), and (V) other reasons, of which most commonly commercial arguments based on cost of goods (10%). It is therefore imperative that technologies become available that allow significant de-risking of biopharmaceutical product trajectories in the early research and development phase. The importance of this has been recognized by the field with the introduction of the “Design of Experiments” (DoE) approach, identifying critical quality attributes and performance attributes like yield, glycosylation, potency, and consumable costs of a manufacturing process. Owing to the DoE approach, scientists now have a tool to strategize the development of a novel product candidate. That said, it is often found that due to the complexity of many novel molecules, the number of parameters that need to be tested still requires vast numbers of experiments which are time consuming and costly. 2016 BioProcess International Award Winners – Downstream and Facilities At this year’s Boston Biotech Week the 2016 BioProcess International Award Winners were announced. These awards recognize outstanding achievements in the area of biotherapeutic development and manufacturing processes. This year individuals and companies that made significant contributions to improving biotherapeutics were recognized. Novel technologies in upstream, downstream and analytical application areas were also awarded. I have listed the winners and finalists along with a brief description of the winning achievements for downstream technologies here. For a list of upstream and analytical technology winners, please see 2016 BioProcess International Award Winners – Upstream and Analytical. Gain Productivity in Protein Purification through Column Loading Optimization Because Protein A is a valuable resource in any mAb purification strategy, companies often search for ways to improve the productivity of their affinity chromatography step. One strategy worth further investigation is variable column loading. By varying residence time (RT) over the loading phase, productivity from an affinity chromatography step can be significantly improved.