Bayer Teams Up With Versant Ventures to Develop Stem-Cell Therapies, Obama, paying tribute to Biden and bipartisanship, signs 21st Century Cures Act Tuesday, Consortium Established with €5M EU Funding to Develop Zika Vaccine, Purdue Strikes $790 Million Exicure Deal to Diversify, Seattle Genetics chalks up further clinical trial success in solid tumors, Stem Cells May Be Next Frontier for Diabetes Drugmaker Novo, and GSK Opens Global Vaccine Center in Rockville, MD.
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.
“German pharmaceuticals giant Bayer AG and U.S. health care investor Versant Ventures plan to establish a stem-cell research company, marking the latest effort by a big pharmaceutical company to develop new and innovative drugs by joining with venture capital and biotechnology firms.”
“Obama, paying tribute to Biden and bipartisanship, signs 21st Century Cures Act Tuesday,” The Washington Post
“Paying tribute to both bipartisanship and his vice president — who was galvanized by his own son’s death to change the way the United States combats cancer — President Obama signed legislation Tuesday that aims to increase funding for medical research, speed the development and approval of experimental treatments and overhaul federal policy on mental health care.”
“Zikavax, a consortium of EU research groups, has received €5 million ($5.32 million) in funding from the EU’s Horizon 2020 program to support the development of an affordable Zika virus vaccine. The Zikavax partners include the nonprofit European Vaccine Initiative, which will coordinate the program, together with Vienna-based vaccine firm Themis Bioscience, the Institut Pasteur (Paris), and the French government-funded research organization, Commissariat à l’énergie atomique et aux énergies alternatives (CEA).”
“Purdue Pharma LP has struck a deal with Exicure Inc. to buy the rights to an experimental psoriasis treatment for as much as $790 million, the latest in a string of moves to diversify away from opioid pain drugs, the backbone of the company’s business.”
“Seattle Genetics could move beyond its core focus in blood cancers and into the solid tumor setting, if positive early-stage data is backed up by further trials. The company said its antibody-drug conjugate SGN-LIV1A has shown efficacy in patients with triple-negative metastatic breast cancer—a particularly hard-to-treat patient population—in a Phase I trial presented at the San Antonio Breast Cancer Symposium (SABCS).”
“Novo Nordisk A/S, the world’s biggest maker of drugs to treat diabetes, says it’s making progress on the long road to a potential cure. Novo’s Stem Cell Research may enter clinical trials within five years, Chief Executive Officer Lars Rebien Sorensen said in an interview. The target is a lifelong form of diabetes in which the body’s defense system attacks and destroys cells that make insulin — the hormone tasked with converting blood sugar into energy. “This will happen,” said Sorensen, who will retire in coming days after 16 years at the helm of the Danish drugmaker.”
“GlaxoSmithKline (GSK) today will officially open its newest global vaccines R&D center in Rockville, MD, where the pharma giant will base 450 researchers and support staffers and spend $50 million over the next 2 years on technology and equipment.”