This week’s biotechnology news headlines include, remembering Dr. Jonas Salk, Novartis aims to almost triple biosimilar drugs on the market, FDA releases new draft guidance on bioequivalence studies, NIH to review first human use of CRISPR/Cas9 technology, Inovio Pharma to test Zika vaccine in human trial, and Merck’s Keytruda prolongs life in large lung cancer study.
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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a plenary lecture by a distinguished professor in the field of bioprocessing, and you will also benefit from access to unpublished data.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.
“Scientists racing to develop a vaccine against Zika virus disease this summer may be hoping for results like those of Dr. Jonas Salk, creator of the first successful vaccine against poliomyelitis. Dr. Salk died on this day in 1995 at the age of 80, decades after the polio vaccine he developed helped vanquish the deadly, paralyzing disease throughout much of the world.”
If you like this story, please see our blog titled “Ensuring Removal of Residual Enzymes in Biomanufacturing – Trypsin and Collagenase”
“Switzerland’s Novartis pledged to nearly triple its number of biosimilar drugs on the market by 2020, raising its bet that cheaper versions of blockbuster cancer and immune system medicines will snatch billions in rivals’ profits.”
If you like this story, please see our blog titled “Cool Tool – Clarification using Acoustic Wave Separation offers Advantages including -Continuous Process Solution”
“FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions,” Regulatory Focus
“The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.”
If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”
“NIH’s Office of Science Policy said the agency’s Recombinant DNA Advisory Committee (RAC) will meet June 21-22 to discuss a proposed Phase I trial using CRISPR/Cas9 gene editing as part of a chimeric antigen receptor (CAR) T Cell Therapy. NIH said the study would be the first human use of CRISPR/Cas9 technology.”
If you like this story, please see our blog titled “Cell Flask Adapters Can Streamline the Cell Culturing Process”
“Drug developer Inovio Pharmaceuticals Inc and its partner GeneOne Life Sciences Inc said they had received approval from U.S. regulators to start an early stage human trial testing their Zika vaccine.”
If you like this story, please see our blog titled “Cool Tool – Off the Shelf Optimized CHO Media and Feed”
“Cerus said it has inked an up to $180.5 million agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support the company’s clinical development program for pathogen reduction of red blood cell (RBC) components.”
If you like this story, please see our blog titled “New Poster: Proving Clonality – A Documented Clonality Report for Regulatory Submission”
“Advanced lung cancer patients who took Merck & Co’s Keytruda immuno-oncology medicine in a large trial and were previously untreated went longer without their disease worsening and showed a survival advantage over those given standard chemotherapy, the drugmaker said on Thursday.”
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”