This week’s headlines include, problems with stem cell lines for clinic, scientists try stem cell acid test, President’s cancer panel recommends HPV vaccines, measles death drop 74 percent in decade, nasal vaccine protects mice against West Nile, life science industry analysts foresee more divestitures and deals, and FDA supports flexible approach to drug development.

Cell Culture Dish – Ask the Expert:

Our Next Session – Troubleshooting Cell Culture Media for Bioprocessing

Cell culture media, including basal media and feeds, are key elements impacting the performance of bioprocesses. Advancements in cellular and metabolic understanding, coupled with high throughput applications, have led to evolved approaches in medium development and optimization resulting in innovative cell culture media with desired characteristics to meet specific needs. However, challenges associated with the use of cell culture media still exist. In this Ask the Expert session, we invite you to participate in discussions on experience and lessons learned around cell culture media troubleshooting.

This Ask the Expert Session is Sponsored by GE Healthcare Life Sciences and hosted by Peggy Lio, Director of Process Science, GE Healthcare Life Sciences. Ms. Lio is responsible for leading the technical applications strategy for the US cell culture business. She joined GE from Life Technologies where she was responsible for the development of PD-Direct Bioprocess custom cell line and cell culture media optimization service programs globally. She also led an applications team charged with scientific support of new cell line and media products as well as process development.

Don’t miss the chance to ask your cell culture media related questions, session starts Monday!

Cell Culture Events

IBC’s 2nd Annual Flexible Facilities Conference

Innovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines, Global Markets, On-Demand Scale-up/Scale-down and Capacity Optimization
Event Website: www.IBCLifeSciences.com/Facilities

IBC’s 2nd Annual Flexible Facilities conference brings together senior level executives and scientists from biopharmas, CMO’s, technology providers, engineering firms and regulatory groups to explore the changing landscape of biologics manufacturing and to share case studies of the latest flexible facility implementations, lessons learned and practical experiences.

New registrations, Save 20% off the standard rate with priority code FLEX14CCD.

Download the event brochure (PDF): http://bit.ly/1e2lhlX

Cell Culture World Congress

February 25-27, 2014 – Hotel Sofitel Munich Bayerpost – Munich Germany

The 4th annual Cell Culture World Congress 2014 is the region’s largest event dedicated to process enhancement, technological innovation and business development.

It is an exhibition, a strategic keynote conference, technical roundtables and practical workshops.

It is an interactive 3 day, dual-tracked event with multiple, disruptive learning formats that facilitates high level discussion on what matters in the industry right now:

• Optimisation of cell culture biologic production
• Exploring the potential of cell line engineering
• New technologies to enhance cell line expression
• Assessing media selection options
• Delivering a robust upstream process
• Evaluating novel upstream technologies
• Process scale-up and scale-down challenges

If you are attending the Cell Line Development and Engineering Conference, please visit:

GE Healthcare Booth #25

Please join us for the 2014 Cell culture world conference in Munich. Come and meet us at booth # 25 and listen to an interesting presentation entitled “Management of films and polymeric materials used in cell culture and single-use bioprocess equipment – A case study on Irgafos™ 168” by Dr Sara Ullsten.

HPAPI

February 26-27, 2014 – Hotel Sofitel Munich Bayerpost – Munich Germany

HPAPI World Congress is the region’s leading event dedicated to process enhancement, technological innovation and business development.

HPAPI World Congress is an interactive 2 day event with multiple, disruptive learning formats and offers real practical outcomes around High Potency API Development and High Potency Finished Product Manufacture.

IBC’s Biopharmaceutical Development & Production Week

March 24-27, 2014 – San Diego, CA
Event Website: www.IBCLifeSciences.com/BDPWeek

BDP Week provides you the most in-depth coverage of bioprocessing methods in the field, to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline.

New registrations, Save 20% off the standard rate with priority code BDP14CCD.

Download the event brochure (PDF): http://bit.ly/M4GCiw

Headlines:

“Stem Cell Lines Not Fit for Clinic,” The Scientist

“Many of the stem cell lines used by academics and registered with the U.S. National Institutes of Health (NIH) would not be eligible for commercialization because they don’t pass muster with the Food and Drug Administration (FDA), according to a report published today (February 6) in Cell Stem Cell. The lack of harmonization between the agencies’ standards throws up a potential roadblack on the path from the laboratory to the clinic. “The main concern is: How do we move this technology [to the clinic]? How do we translate it?” said Erica Jonlin, the author of the report and the regulatory manager at the University of Washington Institute for Stem Cell and Regenerative Medicine.”

If you like this story, please see our blog titled “A Discussion on Expansion of Therapeutic Stem Cells using Plant-based biologics”

“Life Science Industry Analysts Foresee More Divestitures, Deals in Diagnostics and Services,” Med City News

“Life science industry analysts at PricewaterhouseCoopers expect a strong environment for mergers and acquisitions this year, with the diagnostics and services sectors potentially seeing a resurgence of deals. While the number of deals in the life sciences fell last year compared to 2012, those transactions were worth nearly $140 billion – 46 percent more than the previous years’ deals. Surprisingly, though, PwC says in its year-end Pharmaceutical and Life Sciences Deals Insights Quarterly report that the industry didn’t see any mega deals that were prevalent in years past.”

If you like this story, please see our blog titled “GE Healthcare’s Acquisition of Thermo Fisher Scientific’s Cell Culture, Gene Modulation, and Magnetic Beads Businesses a Win for Both”

“Why FDA Supports a Flexible Approach to Drug Development,” FDA Voice

“We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association. The study found that FDA used a range of clinical trial evidence when approving 188 novel therapeutic drugs for 208 indications (uses) between 2005 and 2012. These results are entirely consistent with our regulatory mandate. We believe varying approaches to clinical studies to support drug approval is good news, not bad. Data to support the approvals studied were based on a median of two pivotal trials per indication. A pivotal trial presents the most important data used by FDA to decide whether to approve a drug.”

If you like this story, please see our blog titled “2013 FDA New Drug Approvals”

“Nasal Vaccine Protects Mice From West Nile Virus,” Fierce Biotech Research

“A nasal vaccine developed by researchers at Duke University provided protective immunity against West Nile virus in mice after two doses, according to new research presented recently at the American Society for Microbiology Biodefense and Emerging Diseases Research Meeting in Washington, D.C. The mosquito-borne virus, which causes inflammation of the brain and meningitis, first appeared in the U.S. in 1999 and has since caused a reported 2,374 cases of infection in people, including 114 deaths in 2013 alone, according to the Centers for Disease Control and Prevention. An injectable vaccine based on killed virus is available for horses, but no human vaccine is on the market.”

If you like this story, please see our blog titled “Choosing a Cell Culture Media Development Strategy for Biopharmaceutical Production”

“Measles Death Drop 74 Percent in a Decade, Study Shows,” CBS News

“Global vaccination efforts have helped reduce deaths from measles outbreaks by 74 percent in a decade, according to a new study. Measles deaths went down from 535,300 deaths in 2000 to 139,300 in 2010, according to the study published in the April 24 issue of The Lancet. Researchers looked at statistics from World Health Organization (WHO) member states to determine rates. “A three-quarters drop in measles deaths worldwide shows just how effective well-run vaccination programs can be,” Dr. Margaret Chan, director-general of the WHO, said in a WHO press release. “Now we need to take the next logical step and vaccinate children against rubella, too.”

If you like this story, please see our blog titled “New Study Compiles Extensive Database that Supports the Importance of Vaccination”

“The President’s Cancer Panel is Pushing for Increased Use of Merck’s and GSK’s HPV Vaccines,” Fierce Vaccines

“The reasons for low uptake of human papillomavirus (HPV) vaccines have been well researched and widely discussed by academia and government agencies, yet this knowledge has done nothing to increase adoption. Now, the President’s Cancer Panel has weighed in to give momentum to a public health campaign it views as a “profound opportunity” to prevent cancer. An advertising blitz helped Merck ($MRK) get its HPV vaccine Gardasil off to a strong start in 2007, but criticisms of the jab–including Representative Michele Bachmann’s claim it caused “mental retardation”–set back progress. In July the Centers for Disease Control and Prevention (CDC) reported the slow rise in uptake seen in previous years had stalled. The President’s Cancer Panel views this as unacceptable and has published a 57-page report outlining what should be done and why.”

If you like this story, please see our blog titled “Paper or Plastic: A Study on Single-Use and Sustainability”

“Scientists Debate, Try Stem Cell Acid Test,” The Boston Globe

“Already, scientists in laboratories across the world have begun dipping mature cells in acid, hoping to see whether this simple intervention really can trigger a transformation into stem cells, as reported by a team of Boston and Japanese researchers in January. At the Harvard Stem Cell Institute, a number of scientists have embarked on the experiment, which they’re informally calling “stem cell ceviche,” comparing it to the Latin American method of cooking seafood in lime and lemon juice. The range of responses varies widely. Most scientists seem surprised and skeptical about the technique, but also impressed by the rigorous testing that experts in the field did on the cells. It appears that no one knows quite what to think.

If you like this story, please see our blog titled “A Review of Best Practices For Cell Culture Media Design And Processes”