This week’s headlines include, scientists create liver from stem cells, preparation for H7N9, ViaCyte raises $10.6M, Biotech fundraising in overdrive, Pharma set for growth surge, Senate committee approves additional funding for NIH, and Genentech awaits decision on new leukemia drug.

Cell Culture Dish Feature – Ask the Expert:

Our Next Session – How to Ensuring Integrity and Sterility of Single-Use Assemblies for Manufacturing

While single-use systems have many clear advantages, one challenge is ensuring the integrity of these plastic bags and components. Microscopic breaches of integrity, even those that cannot be seen, can allow microbial ingress. Possible breaches extend beyond just the bags, so the entire single-use assembly including tubing, connectors, seals, etc. must be tested for integrity to ensure against potential contamination problems.

To address integrity concerns, companies that manufacture single-use components will typically conduct a visual inspection and perform pressure decay testing. Pressure decay testing is the industry standard for validating single-use bag integrity, however there are limitations to the level of assurance this testing can provide.

ATMI’s HIT™ system addresses both the challenge of testing complete single-use assemblies and ensuring bag integrity at point-of-use. The system was first launched in 2010 as an in-house add-on testing service for the company’s 2-D bioprocess bags and manifolds, and now the HIT system has evolved to the next level. It is offered in multiple formats: either as add-on testing for the full line of ATMI 2-D and 3-D vessels up to 200L, or as a point-of-use-system to customers for implementation in their own facilities.

The expert for this session is Carla Conant, Global Product Manager, ATMI. Please take advantage of the opportunity to ask Carla a question and participate in a lively discussion about testing the integrity of single use systems!

For more information, please see our blog titled “Ensuring Integrity and Sterility of Single-Use Assemblies”

Cell Culture Events:

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.

Headlines:

“Scientists Create Early Liver from Human Stem Cells,” Bloomberg Buisinessweek

“Scientists used human stem cells to create precursors to human livers like those in fetuses, and the early organs functioned as livers when transplanted into mice. These buds didn’t grow into regular livers and any treatment for humans is at least a decade away, according to the research published in the journal Nature. Still, the study demonstrated the first steps toward potentially creating new organs for transplants, researchers said.”

If you like this story, please see our blog titled “New and Improved Cultureware is Designed with the Scientist in Mind”

“Pharma Set for “Growth Surge” to 2018, Study Forecasts,” PharmaTimes

“Worldwide prescription drug sales fell 1.6% in 2012, but from this year they are set to start growing slowly and will then steadily increase, to reach a value of $895 billion by 2018, according to new research. The worst of the patent cliff is now in the past, according to the study, the sixth annual World Preview report produced by life science sector analysis group Evaluate. The study is forecasting a surge in drug approvals, R&D productivity and investor confidence which it says will drive expansion to 2018.”

If you like this story, please see our blog titled “A New WAVE for the Future”

“ViaCyte Raises $10.6M as Artificial Pancreas Moves Toward Key Trials,” Xconomy

“ViaCyte, the San Diego regenerative medicine startup with a big idea for using stem cell-derived therapy to treat diabetes, says today it has raised $10.6 million through a private equity financing. The deal included the company’s largest existing investors—Johnson & Johnson, Sanderling Ventures, and the Johnson Trust. ViaCyte says the funding matches the $10.1 million Strategic Partnership Award (SPA) approved by the California Institute for Regenerative Medicine last October to support clinical evaluation of the company’s encapsulated cell-therapy product. ViaCyte is developing the technology for patients with type 1 and insulin-dependent type 2 diabetes.”

If you like this story, please see our blog titled “Cell Line Authentication – A discussion on protecting research against cell line contamination”

“Biotechs Burning Rubber as Fundraising Still in Overdrive,” BioWorld

“Global biotech companies continued their torrid fundraising pace generating almost $6 billion in the second quarter of 2013, a 20 percent uptick on the respectable $5 billion raised in the first quarter of this year. In the period public companies led the way, taking advantage of their ever improving share values to conduct public financings. When you add 16 global initial public offerings (IPOs) into the mix it was not surprising that public financings represented 61 percent of the total funding raised in the second quarter according to BioWorld Snapshots. Now that we have reached the half-point of the year global biotechs have pocketed almost $11 billion, a 37.6 percent increase of the total raised in the same period of 2012. Approximately 63 percent of the 2013 total came from public offerings and this amount was 72 percent higher than the year earlier total.”

If you like this story, please see our blog titled “Perfusion Bioreactors – With so much to offer they deserve a closer look”

“Senate Committee Approves Funding Increase for NIH in FY 2014,” Fierce Biotech Research

“The Senate Appropriations Committee approved a bill Wednesday that would provide $30.95 billion in funds for the National Institutes of Health for fiscal year 2014–an increase of $307 million from the agency’s current budget. The bill offers a glimmer of hope to scientists who will inevitably feel the effects of sequestration, which cut NIH’s budget by 5%–or $1.55 billion–across all of the agency’s programs, projects and activities. In 2012, NIH’s total funding was about $30.86 billion. Under sequestration, that number will be slashed to $29.15 billion this year.”

If you like this story, please see our blog titled “Monoclonal Antibody Production – A discussion on the culturing of mouse hybridoma cells”

“Genentech Eyes Dec. 20 FDA Decision Date for New Leukemia Drug,” San Francisco Business Times

“Genentech Inc. could get an FDA decision by Dec. 20 on a new leukemia drug as the clock winds down on patent protection for its blockbuster Rituxan. The South San Francisco-based biotech drug developer, the U.S. arm of Swiss drug maker Roche, said Wednesday that the Food and Drug Administration gave priority review status to GA-101, or obinutuzumab, as a potential treatment for chronic lympocytic leukemia. The designation shaves months off the agency’s timeline for deciding whether to approve obinutuzumab.

If you like this story, please see our blog titled “Continuous Processing: From Cookie Preparation to Cell-Based Production”

“Manufacturers Prepare for Resurgence of H7N9,” Fierce Vaccines

“The expected summer lull has seen H7N9 activity slow dramatically, but health authorities fear it will return in China and possibly beyond as temperatures cool. If this happens, the advancement of vaccines should strengthen the ability of healthcare systems to protect people. In the past week three manufacturers have reported progress in developing a vaccine to protect against H7N9. Taiwan is the one country outside of China to experience a case of H7N9, and the urgency of its vaccine preparations reflect its precarious position on the border of the virus’ range. Leading Taiwanese vaccine manufacturer Adimmune has already completed Phase III trials, The China Post reports, and expects to make an H7N9 jab available imminently. Adimmune Chairman Steve Chan had hoped the vaccine would be ready by the end of May, but the timeline slipped slightly.”

If you like this story, please see our blog titled “Interesting Late Stage Viral Vaccine Candidates”