In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab)
As part of our Boston Biotech Week 2016 coverage, we will be writing about some of the posters presented at the conference. One poster that caught my eye for downstream was presented by Oncobiologics and JSR Life Sciences, “Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar (Trastuzumab).” In the poster, Oncobiologics and JSR Life Sciences describe the steps taken in identifying the most efficient chromatography process.
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.
Electroporation-based Transfection Demonstrates Consistent Antibody Quality and Glycosylation Patterns for Biotherapeutic Product Development
Increasingly, companies are choosing CHO-based transient production of antibodies in early biopharmaceutical development over stable cell line generation. The advantage of using transient transfection is that it takes significantly less time and cost to generate material when compared with the alternative of developing a genetically stable cell line for manufacturing. This is particularly important in drug development where preclinical material is needed quickly in order to make informed go/no go decisions. Having access to preclinical material faster and with less cost can greatly impact the overall drug development timeline.
Cool Tool – Cell Culture Basics Virtual Lab
I recently found a very cool tool for beginning cell culture scientists or scientists looking to verify their knowledge. It is called the Cell Culture Basics Virtual Lab. The virtual lab is part of Thermo Fisher Scientific’s Gibco™ Education series.
Video – Bioprocessing pH Probe Selection and Maintenance
pH is one of the most important parameters in maintaining a healthy cell culture. pH probes are used to measure pH in bioreactors, but often there are questions about probe selection, cleaning and maintenance. In this week’s Two Minute Tuesday video, Robert Garrahy, Vice President of Bioprocess Technologies at Broadley-James is interviewed about how the most important factors in probe selection as well as important cleaning and maintenance recommendations.
Cool Tool – Kits to Simplify and Standardize Your Immune Cell Cultures
Cells of the immune system, including macrophages, dendritic cells, B cells, T cells, and NK cells are actively being used for many research and therapeutic applications. Cell therapy, immunotherapy, and drug discovery are just a few areas where the culture, expansion, and differentiation of these immune cells is especially utilized. However, this culturing process is not trivial. Maintaining, differentiating, and expanding immune cells can be difficult. In addition, many scientists use immune cells in their cross-disciplinary research. While these scientists are experts in their area of research, they are often not experts in culturing immune cells, in particular, the methods used to differentiate and expand them in culture.