This week’s headlines include: Single Shot at Doctor’s Office May Be Future of HIV Prevention, GE Healthcare Licenses Cytiva Cardiomyocyte Rights to Ascendance Biotechnology, The head of the FDA defends the importance of drug effectiveness, Gates Foundation to Invest Up to $140 Million in HIV Prevention Device, December CHMP decisions bring year’s total approvals to 81, and Florida universities, backed by $10 million federal grant, at center of Zika research.
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.
“Truvada, the other “little blue pill,” is taken daily to prevent HIV and has been touted as a miracle drug responsible for lowering HIV rates across the United States. But soon, the daily pill may be overshadowed by an even simpler method—a single flu shot-like injection at the doctor’s office, once every two months.”
“GE Healthcare Licenses Cytiva Cardiomyocyte Rights to Ascendance Biotechnology,” Genetic Engineering News
“GE Healthcare has licensed to Ascendance Biotechnology rights to manufacture, market, and sell the GE Healthcare Cytiva® brand of human stem cell-derived cardiomyocytes used for evaluating potential cardiotoxicity, Ascendance said today.”
“First things first: Food and Drug Commissioner Robert Califf says that he has not had any contact with the Trump transition team. That’s the latest sign that the cardiologist, confirmed as FDA chief less than a year ago, will be heading back to Durham, N.C., where he’s on leave from Duke University. Still, he has no regrets: “Everyone who knows me knows I have just had fun every day on the job,” he said in an interview.”
“The Bill & Melinda Gates Foundation is investing as much as $140 million to support development of a tiny implantable drug pump it believes could help prevent people in sub-Saharan Africa and elsewhere from becoming infected with HIV, the virus that causes AIDS.”
“The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed seven new medicines for approval at its December meeting, bringing the total number recommended during the year to 81, dropping from 2015’s tally of 93.”
“Florida has been the epicenter for Zika in the United States and is now poised to become a national hub for efforts to fight the virus. On Thursday, the Centers for Disease Control and Prevention (CDC) announced a $10 million grant to four Florida universities for research on how to keep the Zika virus from spreading. The grant will fund a collaboration between the University of Florida, the University of Miami, Florida International University and the University of South Florida to study Zika and other diseases spread by vectors like mosquitoes.”