This week’s headlines include, universities’ discovering drugs, drug conjugates, FDA and NIH back to work, Cellular Dynamics issued patent, Dynavax planning hepatitis vaccine study, new approach for universal flu vaccine, and new technology could replace animal testing.
Cell Culture Dish Feature – Ask the Expert:
Our Next Session – Stir Up Your Culture – Learn How to Succeed with Xcellerex Bioreactor Applications in a Manufacturing Environment
Xcellerex XDR single-use, stirred-tank bioreactors are well-characterized systems that deliver a performance comparable with that of conventional bioreactors from process development to manufacturing scale. The technology has been successfully used in a variety of different applications including mammalian suspension cell culture, microbial fermentation and cultivation of adherent cells using microcarriers.
This Ask the Expert Session is Sponsored by GE Healthcare Life Sciences and hosted by Patrick Guertin, Senior Manager, Upstream Process Development and Pilot Plant, Xcellerex, now part of GE Healthcare Life Sciences. Mr. Guertin has 25 years of experience and significant expertise in upstream process development, pilot plant operations and cGMP manufacturing for recombinant therapeutics, monoclonal antibodies and vaccines.
Don’t miss the chance to ask your bioreactor related questions, session starts Monday!
Cell Culture Events:
Don’t Miss Vaccines: Formulation Development, Manufacturing and Novel Production Technologies December 4-5th 2013, Sheraton Brussels Hotel, Belgium
Informa’s annual Vaccines: Formulation Development, Manufacturing and Novel Production Technologies introduces an industry-led and scientific-driven agenda providing the latest in vaccine R&D innovation, optimising pre-clinical models, adjuvant and formulation development, novel production platforms, streamlining process development and manufacturing approaches. The 2013 conference provides the ideal mix of big pharma and small biotech to provide a varied and well represented networking opportunity.
Share a brief write-up on how you used the WAVE Bioreactor to solve a problem, increase productivity, improve efficiency or improve your cell culture results.
Four Winners will have their stories featured on The Cell Culture Dish Blog.
One Grand Prize Winner will be selected to receive a special winner’s plaque and an exclusive opportunity to get the results published in a well-known forum.
Enter here – /WAVE25/
Don’t miss the chance to tell your success story!
Introduction to Cell Culture –December 10-13, 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.
“Merck’s recent announcement about dramatically cutting R&D is just the latest such move in the pharmaceutical industry. Merck joins a number of companies including Pfizer, Lilly, AstraZeneca, etc., who have reasoned that decreasing sales due to patent expirations necessitates “right sizing” its internal R&D operations. All of these companies have sought to lower costs through greater efficiencies and slimming down R&D programs. However, to meet the budget goals, far more drastic cuts are needed and so companies are eliminating a good deal of their “bricks & mortar” – the R&D labs. The labs where iconic drugs such as Singulair, Lipitor, Viagra and Celebrex no longer exist as they have fallen to the budget axe.”
If you like this story, please see our blog titled “Bioprocess International Conference – Thursday’s Talks”
“Harvard, AstraZeneca Partner to Replace Animal Testing with “Organs –on-Chips,” Fierce Biotech Research
“As Big Pharma scales back R&D spending, especially in the area of preclinical research, companies are looking for new ways to save money and test drugs more effectively and cost-efficiently. Tissue chips that mimic the biological function of organs, called “organs-on-chips” and developed at Harvard University’s Wyss Institute for Biologically Inspired Engineering, may be able to provide drug developers at AstraZeneca ($AZN) with an alternative to animal testing.”
If you like this story, please see our blog titled “Moving Your Cell Therapy from Concept to Product – A discussion about navigating funding and grant writing, partnering with organizations and the regulatory process”
“Only two antibody-drug conjugates are on the market—Roche’s Kadcyla for breast cancer and Seattle Genetic’s Adcetris for lymphoma—but developers are stepping up investment in this new drug class. ADCs promise side-effect-free therapies by linking potent cytotoxins to monoclonal antibodies to deliver a killing agent directly to tumor cells. Combined sales of Adcetris, approved in 2011, and Kadcyla, approved last year, reached $160 million in the first half of 2013. Even though most other ADCs are still in the early stages of development, the market could grow to $9 billion by 2023, according to the London-based market research firm Roots Analysis.”
If you like this story, please see our blog titled “Single-Use Bioreactor Mixing: How to Meet Familiar Requirements with Novel Technologies”
“The good news is that the government is up and running again and a default on federal bills has been averted for at least another few months. The bad news is that government agencies, including the FDA and National Institutes of Health (NIH), are once again pinned to last year’s sequestered spending levels. The continuing resolution (CR) signed into law Wednesday will keep the government fully functioning through Jan. 15, 2014, ending the first government shutdown in 17 years. But unless Congress can agree on a fiscal 2014 budget before then, the FDA’s spending for the first third of the year will be based on the $4.2 billion appropriated in fiscal 2013, minus the 5 percent sequestration cut.”
If you like this story, please see our blog titled “Developability: Smart Ways of Avoiding the “Death of the Brave” During Biotherapeutic Development”
“Cellular Dynamics Issued Patent for Creating Blood Vessel, Blood Cells,” Milwaukee Journal Sentinel
“Cellular Dynamics International Inc. said Wednesday it was issued its fifth patent this year by the U.S. Patent and Trademark Office. The Madison stem cell company said the newly issued patent relates to the method by which induced pluripotent stem cells are developed into diverse types of blood vessel and blood cells.”
If you like this story, please see our blog titled “Single-Use Stirred Bioreactors – Enabling Flexible Biomanufacturing”
“Researchers at St. Jude’s Children’s Research Hospital have developed a new approach for creating an influenza vaccine that could guard against multiple flu strains, including pandemic ones. Current flu vaccines work by generating highly specific antibodies that target and bind tightly to strain-specific regions of hemagglutinin (HA) and neuraminidase (NA) proteins on the virus. Because HA and NA proteins constantly change and evolve, this approach requires developing a new flu vaccine every year.”
If you like this story, please see our blog titled “Innovative Products Featured at the Bioprocess International Conference – Part I”
“Dynavax Technologies Corp. plans an 8,000-person Phase III trial of its hepatitis B vaccine Heplisav, starting early next year. It will cost up to $55 million. Berkeley-based Dynavax (NASDAQ: DVAX) designed the new test in hopes of satisfying the Food and Drug Administration, which told Dynavax a year ago it would have to collect more safety data on the treatment.”
If you like this story, please see our blog titled “Advances in Adherent Cell Culture Approaches Abound – Promoting Progress in Production Performance for Attachment Dependant Processes”