This week’s biotechnology news headlines include, US panel backs approval of Merck’s infectious diarrhea drug, FDA approves PaxVax’s Vaxchora to prevent cholera, Shire buys bowel drug rights from Pfizer, Merck has agreed to purchase Afferent Pharmaceuticals, FDA to discuss two biosimilars, Roche backed researchers recruit immune system against cancer, and Missouri governor signs bill to create pathway for interchangeable biologic medicines.
Cell Culture Events
Enhancing Fermentation Results with Advanced Bioprocess Control
Date: June 21, 2016, 11:00 am EST
Cedex Analyzer Family for bioprocess monitoring
In each bioprocess, one of the crucial factors is control over the fermentation process with reliable product quality and yield. Therefore, there is a strong need for reliable analytics with low maintenance efforts. Biomanufacturers seek analytical solutions providing high accuracy and precision, automation and integration, as well as less user-interference with reduced hands-on time.
Accurate monitoring of complete culture physiology inside fermenters is simple and fast with Cedex Analyzers from Roche Custom Biotech. This family of instruments performs precise measurements of even subtle changes in nutrients, metabolites, or cell morphology and growth, enabling informed decisions and real-time response. Featuring a continuously growing test portfolio, the Cedex instruments offer relevant analytics on one platform with powerful testing capabilities and reduced workflow complexity.
Cedex Analyzers enable tight control over the process and fully support the Quality by Design approach for bioprocess monitoring in pharmaceutical development and manufacturing. Reliable analytics allow full characterization of all influencing factors, such as substrates, metabolites and products. In addition, Cedex Analyzers enable a high level of integration in automated workflows.
Learn more about reliable diagnostics for your bioprocess. Leave nothing to chance and register for the webinar right now.
Christian Weilke, International Product Manager
Christian holds a PhD in chemistry and joined Roche in 1999. Since 2010, he is working in Custom Biotech in different positions, now being responsible as International Product Manager for the Pharma In-process Control portfolio.
Please visit http://bit.ly/1N457uK
Bioprocess Insights Webinars
The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the overall business strategy.
In this webinar series, four renowned subject matter experts will share their insights into four areas of bioprocessing: upstream, vaccines, downstream, and single-use technology. We will present tangible, recently developed data that can help you in developing modern, cost-efficient, and sustainable bioprocesses.
Don’t miss these on demand webinars – http://www.bioprocessintl.com/sponsored-content/bioprocess-insights-webinars/
Progress in Continuous Biomanufacturing – June 27-28, 2016 – Robinson College, Cambridge, UK
The conference is enhanced by the participation of several leading industrial technologists, scientific, vendors and also leading academics from Europe and USA. They have come forward to share their experience and knowledge to provide a better understanding of the current technologies and their application in continuous biomanufacturing. There is also a plenary lecture by a distinguished professor in the field of bioprocessing, and you will also benefit from access to unpublished data. This meeting will address several advancements and their successful application with data in the Technology both Upstream and downstream and also on Initiatives to process developments and project to the future direction of the industry. By joining with us you can benefit from the current state of-the-art advancements in continuous manufacturing and also learn about the successful organisations that are developing and applying these methods in-house.
Viral Safety and Raw Materials – June 2016, Vienna, Austria
“Merck & Co’s experimental drug to treat the most common cause of hospital-associated infectious diarrhea warrants approval, an advisory panel to the U.S. Food and Drug Administration said on Thursday.”
If you like this story, please see our blog titled “Albumin Fatty Acid Profiles for cell culture media – Enabling Albumin Optimization for Cell Culture Media”
“FDA approved a BLA for Vaxchora (PXVX0200) from PaxVax Inc. (Redwood City, Calif.) to prevent cholera caused by serogroup O1 in adults aged 18 to 64 traveling to cholera-affected areas. PaxVax received a Priority Review voucher upon approval, as part of FDA’s neglected tropical disease voucher program.”
If you like this story, please see our blog titled “Automated Stem Cell Based High Throughput Drug Screening for ALS and Parkinson’s Disease”
“Irish drugmaker Shire Plc said it would buy the rights to an experimental bowel drug from Pfizer Inc to bolster its pipeline of gastrointestinal treatments.”
If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”
“In its most sizable deal in over a year, Merck (MRK) has agreed to shell out as much as $1.25 billion for Afferent Pharmaceuticals, a clinical-stage biotechnology company focused on drugs that treat various neurogenic conditions including the chronic cough.”
If you like this story, please see our blog titled “Poster: Purpose-designed Protein A resins for Improved Downstream Process and Cost Efficiency in MAb purification”
“FDA scheduled advisory committee meetings to discuss BLAs for biosimilar etanercept (GP2015) from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) and brodalumab (KHK4827) from Valeant Pharmaceuticals International Inc. (TSX;VRX; NYSE:VRX).
If you like this story, please see our blog titled “Cool Tool – Off the Shelf Optimized CHO Media and Feed”
“Roche-backed researchers find a way to lure back immune system from cancer’s grasp,” Fierce Biotech
“Cancer cells have a nasty capacity to steer the body’s immune system to actually help them grow, stopping a key defense against cancer development–but researchers have now found a way to recruit the immune system back to its native side.”
If you like this story, please see our blog titled “New Poster: Proving Clonality – A Documented Clonality Report for Regulatory Submission”
“Missouri Gov. Nixon signs bill ensuring patient access to interchangeable biologic medicines,” LifeScienceDaily
“The Biotechnology Innovation Organization (BIO) and the Missouri Biotechnology Association (MOBIO) applauded Gov. Jay Nixon (R-MO) on Wednesday for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.”
If you like this story, please see our blog titled “Cell Culture and Single Cell Passaging of Human Pluripotent Stem Cells Without the Need for ROCK Inhibitor”