This week’s headlines include, BIO and PhRMA announce new tracking database, stem cell market expected to grow significantly according to new report, biosimilar news, EU’s new drug data stance, and rubella epidemics in Japan and Poland.

Cell Culture Dish Feature – Ask the Expert:

Our Next Session – Monoclonal Antibody Production and the Culturing of Mouse Hybridoma Cells.

The production and maintenance of a hybridoma cell begins with the fusion of a specific antibody producing B cell, to a cancer B cell called a myeloma, which does not produce an antibody by itself. Fusion results in an immortalized line called a hybridoma that will faithfully produce a specific antibody against a single epitope called a monoclonal antibody. Once produced, proper maintenance and culturing is required to maximize the performance and continued production of the antibody in question. Have you ever wondered how this is done? Are you fusing cells to produce your own monoclonal antibodies or wondering about your culturing options. This is your opportunity to ask questions about monoclonal antibody production and the culturing of mouse hybridoma cells.

This Ask the Expert Session is Sponsored by Life Technologies and 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 hybridoma cell culture!

Headlines:

“BIO, PhRMA Announce Plan to Keep Tabs on PDUFA Progress Through Tracking Database,” Regulatory Focus

“The Prescription Drug User Fee Act (PDUFA) is one of the single most important pieces of legislation affecting the life sciences industry, and in particular innovative pharmaceutical and biopharmaceutical companies. It is, at its most basic element, a trade-off between pharmaceutical companies and the US Food and Drug Administration (FDA). In the 1990s, an industry frustrated with the slow pace of drug approvals got together with FDA to float a proposal: If FDA would agree to hire more staff, adhere to timelines for reviewing drug products and make other improvements to regulatory capacity, the industry would fund the entire expansion through user fees.”

If you like this story, please see our blog titled “Ensuring Integrity and Sterility of Single-Use Assemblies”

“The FDA’s Cancer Czar Says He Can’t Approve New Drugs Fast Enough,” Forbes

“Maybe more than any other person alive, Richard Pazdur, the director of the Food and Drug Administration’s Office of Oncology and Hematology Products, personifies the tension between the need to get new drugs to patients fast and the competing desire to make sure they are safe and effective first. To his critics, he is an compassionless bureaucrat who denies cancer patients lifesaving medicines using red tape and fine print. In 2007, Richard Miller, the chief executive of a company called Pharmacyclics whose drug had been rejected, wrote a series of opinion pieces in the Wall Street Journal accusing the FDA of “stifling, rather than encouraging, investments in innovation through cumbersome and over-restrictive policies.” A New York Times profile referred to him as “the man who says no.” He received threats and was called a murderer. Another drug rejection, of the prostate cancer treatment Provenge, led 200 protestors to picket the FDA chanting “Pazdur must go!”

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

“Rubella Epidemics in Japan and Poland,” The New York Times

“Japan and Poland are both experiencing epidemics of rubella, and the Centers for Disease Control and Prevention has issued travel warnings suggesting that women who are pregnant or might be consult their doctors before visiting either country. The disease, also known as German measles, usually causes only mild fever and rash in adults and children, but can be devastating to a fetus, causing stillbirth or a host of birth defects, including developmental disabilities, deafness, heart problems and cataracts. Rubella cases in Japan have shot up to over 10,000 and are still increasing. Because of peculiarities in Japan’s vaccination history, nearly 75 percent of the cases are in men ages 20 to 40.”

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

“EU’s Drug Data Stance Threatens Investment – Sanofi CEO,” Reuters

“A decision by Europe’s drug regulator to release detailed data on drugs once a medicine is approved could discourage critical investment in crisis-hit Europe, Sanofi’s chief executive said. Chris Viehbacher, who took over as president of the European Federation of Pharmaceutical Industries and Associations (Efpia) on Monday, said companies would invest in regions where they felt welcome.”If you, on the other hand, say, ‘you guys are bad actors, we want to cut your prices, we want to take your confidential data and share it with any one of your competitors’, you don’t get the same feeling of encouragement,” he told reporters.”

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

“Stem Cells Market is Expected to Reach USD 119.51 Billion Globally in 2018: Transparency Market Research,” Sacramento Bee

“According to a new market report published by Transparency Market Research “Stem Cells Market (Adult, Human Embryonic , Induced Pluripotent, Rat-Neural, Umbilical Cord, Cell Production, Cell Acquisition, Expansion, Sub-Culture)-Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 – 2018,” the market for stem cells was valued at USD 26.23 billion in 2011 and is expected to reach an estimated value of USD 119.51 billion in 2018, growing at a CAGR of 24.2% from 2012 to 2018.”

If you like this story, please see our blog titled “Clinical Stem Cell Manufacturing – A discussion on scaling up from the lab to the clinic”

“Novartis Test Copy of Amgen’s Enbrel in Late-stage Trial,” Reuters

“Sandoz, the generics unit of Novartis, has launched a late-stage trial with its biosimilar version of Amgen’s Enbrel, consolidating its leading position in developing cheaper copies of complex biotech drugs. With the start of the major study of its version of Enbrel, or etanercept, Sandoz now has seven Phase III clinical trials across five biosimilar molecules – more than any other company in the industry.”

If you like this story, please see our blog titled “Gene Optimization and Synthesis as Generic Tools for Streamlined Workflows and Expression Enhancement”

“Latest Biosimilar Guidance Raises More Questions,” Genetic Engineering News

“Testifying before Congress in April, FDA Commissioner Margaret A. Hamburg, M.D., sought to reassure lawmakers: “We are developing a science-based process for bringing safe and effective biosimilar and interchangeable products to market, which should increase competition and create substantial savings for patients, healthcare providers, and insurers.” More than a year after issuing three draft guidances on biosimilars, however, FDA has been unable to show industry and others little progress beyond a fourth draft guidance issued in March on formal meetings between the agency and biosimilar sponsors. And judging from comments by drug developers during a comment period that ended May 31, industry has numerous questions it wants FDA to address.”

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