This week’s headlines include, follow-on biologics, antivirals against Ebola and Marburg, avian flu vaccine shows promise, diabetes breakthrough through stem cells, and Shire seeks to boost its rare disease portfolio.

Cell Culture Dish Feature – Ask the Expert:

Our Next Session – Best Practices For Cell Culture Media Design And Processes

Have you had the problem that a new cell line in your laboratory is not growing to your expectations or cells that had been growing well in your medium all of a sudden start looking sick and are going into apoptosis?

The classical cell culture medium consists of amino acids, vitamins and a source of energy, such as glucose, in a buffered salt solution. These formulations require further supplementation with a protein source such as serum. The classical media formulations were designed using cancer-derived cell lines and can be very sub-optimal for the growth of specialized cells, such as stem cell, recombinant cells and differentiated cells. In the absence of serum and serum proteins it becomes essential that you control for the osmolality, ammonia and the production of free radicals. As important as using the right medium is the proper handling of the both the media and the cells and together can be the difference between a successful or failed experiment.

This Ask the Expert Session is hosted by Paul J. Price, Ph.D., Media Design Consultant. Dr. Price has been a research scientist for over 50 years. Positions he has held include Branch Chief in the Center for Infectious Diseases at the CDC, and founder and Executive Vice-President of Hycor Biomedical. As a Research Fellow at Life Technologies, he helped design much of the specialized media used around the world for the culture (growth) of neurons, stem cells and other mammalian cells, including those used in Bio-Production. He is currently a consultant to several human health companies wanting to develop products in both the areas of Regenerative Medicine and Bio-Production. In June of this year he was awarded a Distinguished Lifetime Achievement Award by the Society for In Vitro Biology for his role in moving research forward in the production of products from cells (Biotechnology) and the use of cells as products (Regenerative Medicine).

If you have had a problem with an experiment or cells, take this opportunity to prevent either from crashing. Dr. Price has over 50 years of experience in cell culture and media design and has had the opportunity to make all of the mistakes and find ways to correct them.

Don’t miss the chance to ask your cell culture media 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.

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.

Headlines:

“Diabetes Breakthrough Found Using Patients’ Stem Cells,” Reuters

“The scientists, who published their findings in the current issue of Diabetes, have uncovered a key biomedical pathway responsible for causing the disease. And they did it by generating stem cells from the skin cells of patients with a rare form of diabetes called Wolfram Syndrome, a rare genetic disorder that leads to insulin-dependent diabetes, blindness and deafness, and is often fatal.

If you like this story, please see our blog titled “Stir Up Your Culture – A Review of our Ask the Expert Session on Single-Use Bioreactors for Biopharmaceutical Manufacturing”

“Tekmira’s RNAi Antivirals Protect Animals from Lethal Doses of Ebola, Marburg,” Fierce Biotech Research

“Canada’s Tekmira Pharmaceuticals ($TKMR) has unveiled new data showing that its antiviral RNA interference therapeutics were effective at abolishing Ebola and Marburg viruses in preclinical studies when treatment was delayed. In a study of the company’s TKM-Ebola drug, which is being developed under a contract with the U.S. Department of Defense, 83% of nonhuman primates survived when treated 24 or 48 hours after being infected with a lethal dose of the Ebola virus. When treatment was delayed to 72 hours after infection, the drug showed a 67% survival rate. Meanwhile, no animals treated with a placebo survived.”

If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”

“Experimental Avian Flu Vaccine Shows Promise in Early Trial,” Reuters

“The first human test of an experimental vaccine against a deadly strain of avian flu, using novel technology that could produce millions of doses very quickly, produced protective antibodies in the vast majority of those who received it, scientists said on Wednesday. The encouraging results in the early stage trial from Novavax, a biopharmaceutical company based in Rockville, Maryland, were published online in the New England Journal of Medicine.”

If you like this story, please see our blog titled “Vaccines an Interesting Discussion of Past, Present and Future”

“What Now: It Still Takes Too Long and Costs Too Much,” The Huffington Post

“It’s not difficult to build a case that the federal government shutdown was just one more straw on the camel’s back for medical research and innovation in the United States. Whether it was the voice of a new mother with sarcoma trying to gain entry to a National Institutes of Health Clinical Center trial, or a researcher lamenting the uncertainty in the funding climate, or news that during the shutdown of the Food and Drug Administration halted the review and approval of new treatments, or photos of the empty room at the Centers for Disease Control and Prevention that tracks global pandemics — coverage about the shutdown was peppered with examples of how relevant U.S. federal agencies are to innovation. Their work is a critical part of the fabric of innovation that takes place in a multitude of locations — at universities, in companies, in clinics, and in the nonprofit sector.

If you like this story, please see our blog titled “Developability: Smart Ways of Avoiding the “Death of the Brave” During Biotherapeutic Development”

“Following Up on Follow-on Biologics,” Genetic Engineering News

“Reinvigorated this year with the first new approvals in three years, Europe’s biosimilars market is heading into 2014 with prospects for more of the same, as branded drugmakers join the generics in launching new near-copies of aging blockbusters. Stada is gearing up to launch Grastofil (filgrastim), a cancer biosimilar of Amgen’s Neupogen®, under a license from Apotex following approval last month. Also, Hospira and Celltrion are preparing to introduce Inflectra (infliximab), their near-copy of Johnson & Johnson’s Remicade, whose European patents expire in 2015. Inflectra is one of two monoclonal-antibody biosimilars approved by European regulators this year; the other was Egis’ Remsima (infliximab). Like Remicade, the biosimilars are indicated for rheumatoid arthritis and other inflammatory conditions.”

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”

“Shire Offers $4.2B for Viropharma to Boost its Rare Disease Portfolio,” Bioworld

“Shire plc is paying $4.2 billion to acquire Viropharma Inc, giving it a stranglehold on the market for hereditary angioedema (HAE) treatments, with the leading products for prophylaxis and for treating acute attacks both residing in the same portfolio. Talk of a possible deal has been bubbling for several weeks and shareholders who were invested in Viropharma before the first rumor surfaced in mid-September will be getting a 64 percent premium. As it is, the offer of $50 per share represents a 27 percent premium to Viropharma’s closing price on Friday.”

If you like this story, please see our blog titled “The Top 10 Biologic Facilities in the US”

“Stemline Therapeutics, US Collaborate to Develop SL-401 in Hematologic Cancers,” Pharmaceutical Business Review

“Stemline Therapeutics, a clinical stage biopharmaceutical company, and The Leukemia & Lymphoma Society (LLS), a voluntary health organization, have announced their collaboration to accelerate the development of SL-401 for the treatment of acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematological disorder with both leukemic and lymphomatous characteristics. LLS has committed over $3m to support this effort, as well as providing a comprehensive educational program to increase physician and patient awareness of BPDCN.”

If you like this story, please see our blog titled “3-D Bioprinting – When cells become ink”