This week’s headlines include, bird flu resistant to Tamiflu, worry about a possible biotech bubble, universal flu vaccine effective in preclinical studies, J&J plans 10 new drug applications, and GSK acquires Okairos.

Cell Culture Dish Feature – Ask the Expert

Our Next Session – All About CHO – Everything from the basics to troubleshooting

In the years since CHO based biopharmaceutical manufacturing began in the 1980’s, the technology has come a long way. Despite continual improvements over the years, including advances in equipment, cell line development practices, and media formulation, gains can still be made in CHO based manufacturing. CHO remains, by far, the most popular cell line for best selling biologics on the market today and as such it is imperative that we continue to find ways to improve on product yield, product quality, cost, and a myriad of other manufacturing challenges. If you are looking for ways to improve your CHO cell line or have a challenge to share, please join us for our Ask the Expert session on everything CHO.

This Ask the Expert Session is Sponsored by Life Technologies and is hosted by Timothy Fawcett, Ph.D. Dr. Fawcett has been in the biotechnology business for over 30 years. Trained as a biochemist he has held senior positions in both academics and industry and has been a mentor to many young scientists throughout his career. For the last 12 years Dr. Fawcett has been the Director of the BioTechnical Institute of Maryland (BTI) a non-profit institute located in Baltimore, Maryland. He is also the Founder and Director of BioSciConcepts, a social venture of BTI that provides hands-on training for professional scientists in cell culture, baculovirus based expression, as well as topics such as molecular biology, PCR and real-time PCR. BioSciConcepts is an internationally recognized provider of expertise in the biological sciences and has provided consultation services to several small and large biotechnology companies.

Please take advantage of the opportunity to ask our expert a question and participate in a lively discussion of everything CHO! Discussion starts Monday!

Headlines:

“Drug Resistance in new China Bird Flu Raises Concern,” Reuters

“The new bird flu strain that has killed 36 people in China has proved resistant to Tamiflu for the first time, a development scientists said was “concerning”. The H7N9 virus was found to be resistant to Roche’s widely used flu drug in three out of 14 patients who were studied in detail by doctors from Shanghai and Hong Kong. Tamiflu, which is given as a pill, belongs to a group of medicines known as neuraminidase inhibitors that currently offer the only known treatment option for bird flu. GlaxoSmithKline’s inhaled medicine Relenza has the same mode of action.”

If you like this story, please see our blog titled “Innovators who Paved the Way for Modern Vaccines”

“Analysis: Biotech’s Bull Run Starts to Look Frothy,” Reuters

“Biotech stocks are so hot that even some of the bulls are starting to find themselves on edge. An index of biotech drugmakers’ shares has climbed nearly 50 percent in the past 12 months to all-time highs as the industry starts to launch drugs developed by identifying genes associated with disease – a revolution made possible by decoding the first human genome more than 10 years ago. The rise at such a fast pace is triggering the inevitable talk of a bubble, especially when investors are reminded that more than 90 percent of experimental drugs that reach mid-stage testing in humans do not make it past that point.”

If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012”

“Universal Flu Vaccine Effective in Preclinical Studies,” Fierce Biotech Research

“Scientists may be one step closer to producing a universal influenza vaccine –a major advancement that could have broad implications for public health around the globe. A team at NIH’s National Institute of Allergy and Infectious Diseases has developed a new approach for immunizing against the flu that elicits a more potent immune response and greater protection than that of currently available flu vaccines.”

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

“J&J to Submit Over 10 New Drug Applications by 2017,” Fox Business News

“Johnson & Johnson (JNJ) said its pharmaceutical unit plans to submit more than 10 new product applications by 2017, as the health-care heavyweight hopes to build on the division’s turnaround in recent years. J&J’s pharmaceutical unit–which used to be its largest by sales but has become eclipsed by the medical-device unit–has been on an upswing, posting full-year sales growth for 2012 and 2011 after three consecutive years of sales declines as older drugs lost patent protection. The company has launched 11 new drug products since 2009 to help jump-start sales growth, including the anti-inflammatory drugs Simponi and Stelara, prostate-cancer treatment Zytiga, the blood thinner Xarelto and diabetes drug Invokana. This has helped replenish a drug unit whose sales were eroded by the loss of market exclusivity for big-selling older drugs, including antipsychotic Risperdal and attention-deficit treatment Concerta.”

If you like this story, please see our blog titled “Interesting Products Featured at Interphex 2013”

“Boehringer in Bother with FDA over Manufacturing,” PharmaTimes Online

“Boehringer Ingelheim says it will act promptly to resolve a series of manufacturing complaints highlighted by regulators in the USA concerning violations at its German headquarters. The US Food and Drug Administration has issued a warning letter concerning the firm’s manufacturing practices following an agency inspection in Ingelheim in November 2012. The FDA has published the letter, dated May 6, on its website noting that investigators that identified significant violations of current good manufacturing practice for the manufacture of active pharmaceutical ingredient and for finished drugs.”

If you like this story, please see our blog titled “Cool Tool – ATMI’s Helium Integrity Testing HIT System”

“GSK Bets on Chimp Virus with $321 mln Vaccine Buy,” Reuters

“GlaxoSmithKline is betting on a new vaccine technology based on chimpanzee viruses by acquiring Swiss-based Okairos for 250 million euros ($321 million) – the latest bolt-on biotech buy by a big drugmaker. Britain’s largest pharmaceuticals group said on Wednesday that the privately owned company’s know-how was expected to play an important role in GSK’s development of vaccines to both prevent and treat diseases. Okairos was spun out from Merck & Co in 2007 and has laboratories in Rome and Naples, with headquarters in Basel. It specialises in making vaccines that target the immune system’s CD8 T-cells – an approach that could yield preventative vaccines against several intractable infectious diseases, including hepatitis C, and also help fight cancer.”

If you like this story, please see our blog titled “New Vaccines Coming Soon to a Doctor’s Office Near You”