This week’s headlines include, Bayer enters deal with Compugen, Thermo’s new plant in Singapore, Glaxo to disclose more data, list of breakthrough designations, Athersys gets funding, four strain flu vaccine ready to ship, and NIH to open genomic data for HeLa cells.
Cell Culture Events:
Now celebrating its 10th Anniversary, BPI attracts experts from all bioprocessing and biomanufacturing disciplines and all levels, from research scientist to group leader to senior level executive who share and discuss their challenges in an interactive, learning environment.
Don’t miss the talk “Downstream Strategies for High-Density Cell Cultures,” by Dr. Gregory Zarbis-Papastoitsis, Vice President of Process and Manufacturing Sciences at Eleven Biotherapeutics. Get a sneak peek by listening to the podcast now!
Three Great Conferences – All in Cambridge, September 30 – October 1
Cell Culture World Congress USA is North America’s premier cell culture optimization and development conference, with a focus on upstream processes. This is where biopharma and biotech biomanufacturing and process experts come to debate advances in cell culture optimization and development. Save 15% with promo code ECYB! For more information please go to www.terrapinn.com/CC13CCDish
Introduction to Cell Culture – August 20-23, 2013
This 4-day cell culture workshop is designed for those with no or extensive cell culture experience. Topics include an introduction to cell and tissue culture, serum containing and serum-free media, adaptation to serum-free media, cell counting and viability staining, growth curve development, growth of suspension and adherent cells, transfection technologies, cryopreservation methods, cell cloning and primary culture.
Scheduled workshops take place in Baltimore, Maryland. All of our workshops can be conducted at your location if needed. If you have questions or want more specific course content please contact our website, www.biosciconcepts.com or call us at 410-752-4224.
“German pharmaceuticals company Bayer AG has entered a new cancer partnership with Israel’s Compugen Ltd to research, develop and commercialise antibody-based therapies. The agreement sent Compugen’s shares up more than 50 percent. The two partners will jointly carry out a preclinical research programme, they said in a statement on Monday. Under the deal, Compugen will receive an upfront payment of $10 million, and is eligible to receive over $500 million in potential milestone payments.”
If you like this story, please see our blog titled “New and Improved Cultureware is Designed with the Scientist in Mind”
“Thermo Fisher Scientific is opening a new manufacturing plant in Singapore to produce dry powder media (DPM), a cell culture raw material used to manufacture biologics including vaccines and anticancer therapeutics. Thermo says the facility is the first-ever cell culture DPM production site in Singapore and is designed to address the increased global requirements from biopharmaceutical companies to mitigate critical raw material supply risks.”
If you like this story, please see our blog titled “A New WAVE for the Future”
“GlaxoSmithKline plans to disclose more individual patient data from its clinical trials to increase transparency in how it reports drug-study results. Since May, qualified researchers can request access to findings on individual patients whose identities are concealed and confidentiality protected. The drugmaker will double the number of studies to 400 available by year’s end to researchers seeking data of approved medicines and of therapies that have been terminated from development, Perry Nisen, senior vice president of science and innovation at Glaxo, said in a report published yesterday in the New England Journal of Medicine.”
If you like this story, please see our blog titled “Quality Testing for Single Use Assemblies – A Review of our Ask the Expert session”
“The U.S Food and Drug Administration has approved shipping of the first vaccine to protect against four strains of seasonal flu. The GlaxoSmithKline vaccine, called Fluarix Quadrivalent, was approved by the FDA last December for use in adults and children aged 3 and older. But approved flu vaccines still have to be certified by the FDA each season before they can be shipped to health care providers. Viruses that cause seasonal flu are classified as A or B strains. Most current flu vaccines provide protection against three strains: the two A strains most common in people, and the B strain expected to be predominant in an upcoming flu season.”
If you like this story, please see our blog titled “Perfusion Bioreactors – With so much to offer they deserve a closer look”
“A potential new way to mend broken hearts has just gotten a boost, as Athersys received an SBIR fast-track grant from the National Heart, Lung, and Blood Institute to support a Phase II clinical study evaluating the administration of Athersys’ MultiStem® therapy to patients who have suffered a heart attack, also known as acute myocardial infarction (AMI). The grant is expected to provide up to $2.8 million in support over the course of the study in connection with study progress and milestone achievement.”
If you like this story, please see our blog titled “From Product Candidate to Product: The Road to Commercialization in Regenerative Medicine”
“Biomedical researchers will now be able to apply for access to the whole genome data of an important cell line known as HeLa. The National Institutes of Health (NIH) made the announcement in Nature Wednesday that the agency has come to an agreement with the family of the late Henrietta Lacks, an African-American woman whose enduring cells have contributed to the development of modern vaccines, cancer treatments and in vitro fertilization techniques, among other medical advances.”
If you like this story, please see our blog titled “Cell Culture, More Science than Art – A Call for Care in Cell Culture Practices”
“With Announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July. With a separate senior management team working solely on the approval of these therapies, FDA stresses the importance of efficient drug development programs that show these medicines demonstrate at least one significant improvement in clinical endpoints for conditions in which therapies already exist.”
If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012”