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:
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.
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.
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.
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.
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.
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.
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.
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.
“In a scientific triumph that will change the way the world fights a terrifying killer, an experimental Ebola vaccine tested on humans in the waning days of the West African epidemic has been shown to provide 100 percent protection against the lethal disease.”
“I’ve been meeting more and more people with cancer lately who would be desperately ill — or worse — had they not taken matters into their own hands and found their way into clinical trials in which they received experimental treatments that put the disease in remission.”
“Roche Holding AG’s emicizumab drug for treating haemophilia A showed it worked in a phase III study, the Swiss drugmaker said on Thursday.”
“MaxCyte has agreed to collaborate with Washington University in St. Louis, which is involved in acute myeloid leukemia (AML) research, to develop immunotherapy drug candidates based on MaxCyte’s proprietary cell-engineering platform technology, CARMA.”
“2017 is promising to be a pivotal year for synthetic biology as two landmark technologies—CRISPR/Cas9 and CAR-T—head toward critical milestones. In the coming months, it is possible that the first therapy based on CAR-T (chimeric antigen receptor T cells) will get regulatory approval, with candidates from Novartis and Kite Pharma that promise to reprogram the immune system to fight cancer currently leading the race to market.”
“The U.S. Food and Drug Administration granted accelerated approval to Clovis Oncology Inc’s ovarian cancer drug in patients with a specific gene mutation whose disease had advanced despite two or more rounds of chemotherapy.“