This week’s headlines include, MS drug doesn’t win approval, gene mapping price to drop, Organogenesis buys Dermagraft, innovation justifies price rises, top 25 M&A deals of 2013, and new stem cell treatment for heart disease gets approval for testing.

Cell Culture Events

6th Annual Biomanufacturing Summit 2014

Now in its 6th year, the Biomanufacturing Summit 2014 attracts senior and executive level industry professionals working within manufacturing, process development and product operations. Through a combination of panel discussions, case studies, keynote sessions, interactive workshops and networking activities, attendees will come to network and exchange knowledge on the latest strategies and technologies available to improve their organizational performance.

Cell Line Development and Engineering

February 10-14, 2014, Austria Trend Hotel Savoyen Vienna, Austria, Austria Trend Hotel Savoyen Vienna

Informa’s annual Cell Line Development & Engineering conference is the go-to European conference to benchmark against leading industry case studies on the latest in novel technologies and strategic approaches in cell banking, quality control, automation, high throughput clone selection, cell line development, cell line engineering and the application of the ‘omics for improved bioprocessing. With 5 days of the latest industry data, interactive focus groups, panel discussions and dedicated networking time, Informa’s event is the conference to ensure streamlined processes and strategies to get products to the market quickly.

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

GE Healthcare Booth #6

Presentation by Olof Larsson:The impact of different feeding strategies on cell culture performance using commercially available media and feeds

The establishment of an appropriate feeding rate and the mode of feed addition are both critical aspects of cell culture fed-batch process development. In this talk, it is presented how both over- and underfeeding can negatively affect cell culture performance and productivity. In addition, continuous versus once-daily (bolus) feeding strategies are compared and the impact of the choice of strategy on culture parameters is discussed.

Flexible Facilities

February 24-25, 2014 · Claremont Hotel & Spa · Berkeley, CA

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.

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

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.

Headlines:

“Drugmakers See Innovation Justifying Further Price Rises,” Reuters

“As U.S. consumers are asked to shoulder more prescription drug costs, drugmakers say prices for brand-name medicines will keep rising, mainly because use of their products reduces other healthcare costs. Switzerland-based Roche Holding AG has a growth rate above the industry average due to its “high-quality” products that command “better prices, with fewer price cuts,” Chief Financial Officer, Alan Hippe said, speaking at the annual JP Morgan Healthcare Conference in San Francisco earlier this week. As long as Roche, maker of drugs like Herceptin for breast cancer, can prove that its new therapies work better than existing drugs, it can maintain pricing trends, Hippe said.”

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

“The FDA Nixes a Pathbreaking Drug for MS,” The Wall Street Journal

“Alemtuzumab is used today as an intravenous treatment for a form of leukemia. But 20 years of research centered at Cambridge University also has shown that the action of this drug—depleting immune cells that become misdirected and attack one’s own body—is effective in treating multiple sclerosis. Under the brand name Lemtrada (a product of Sanofi and its U.S. subsidiary Genzyme), the drug has been approved in recent months for treating MS in 30 countries, including Canada, Australia and all members of the European Union.”

If you like this story, please see our blog titled “The 15 Most Popular Blogs of 2013”

“Top 25 M&A Deals of 2013,” Genetic Engineering News

“Following is a list of the 25 largest merger and acquisition (M&A) deals disclosed in 2013 by drug developers, tools/tech companies, and CROs, ranked by deal value in U.S. dollars. Each acquired company is listed along with its acquirer or prospective acquirer, the price, the status of the deal—has it been completed, or simply announced?—and the percentage premium of the deal price to investors. Most 2013 deals involved big biotechs, and even several big pharmas, snapping up smaller biopharmas. While the year did have a few multibillion-dollar blockbusters, led by Thermo Fisher Scientific’s $13.6 billion buy of Life Technologies (still pending at deadline), that deal was the only one to run into 11 figures. But the next 19 deals on the list ranged from $1 billion–$9 billion, which shows that big deals were alive and well in 2013, if not the uber-deals of recent-past years like Roche-Genentech and Sanofi-Genzyme.”

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

“Human Gene Mapping Price to Drop to $1,000, Illumina Says,” Bloomberg

“The $1,000 human genome sequence is here, according to Illumina Inc. (ILMN). The HiSeq X sequencer is designed to process 20,000 genomes a year at a cost of $1,000 each, said Jay Flatley, Illumina’s chief executive officer. He introduced the machine yesterday at the JPMorgan Chase & Co. health-care conference in San Francisco. Now it costs about $10,000 to sequence a human genome. The industry has been trying to reach the $1,000 for years as a way to make full sequencing more mainstream. Customers, primarily large research centers, will begin receiving the machine this quarter, Flatley said.”

If you like this story, please see our blog titled “Cell Culture, More Science Than Art – A Call For Care in Cell Culture Practices”

“FDA Approves Stem Cell Treatment for Heart Disease: Mayo Clinic to Test Technique in Human Trial,” Medical Daily

“A research project undertaken by the Mayo Clinic for nearly a decade has finally won approval from the U.S. Food and Drug Administration (FDA) to go ahead with testing on humans. The research project involves using stem cells to fix damaged heart tissue, and this step forward is a hopeful sign for millions of people who live with heart disease. The clinical trial will be carried out across several states and will involve 240 patients with chronic advanced symptomatic heart failure. It will help researchers discern whether the stem cell technique will make a marked improvement in heart function, the Mayo Clinic announced last week. The trial will probably take until the end of the year. Previously, Mayo had completed some testing in humans in Europe, which showed promising results — a 25 percent improvement in cardiac outflow, Dr. Andre Terzic, director of the Mayo Clinic’s Center for Regenerative Medicine, said. Terzic called the technique a potential “paradigm shift.”

If you like this story, please see our blog titled “Recombinant Human Transferrin is an Attractive Alternative to Blood-Derived Transferrin in Cell Culture Applications”

“Shire Sells Money-losing Dermagraft to Organogenesis,” Genetic Engineering News

“Shire said today it will sell to Organogenesis assets related to its money-losing living skin substitute Dermagraft for full-thickness diabetic foot ulcers. The deal, which will bring Shire $683 million, is the company’s latest move to shed underperforming operations and focus on key specialties such as rare diseases. Shire said it will record a loss on disposal and associated impairment charges of about $650 million in the fourth quarter of 2013, which will be excluded from non-GAAP earnings. Shire will receive no money up front from Organogenesis but could get up to $300 million in milestone payments if Organogenesis meets annual net sales targets between now and 2018 that increase from $70 million in 2014 and 2015 to $250 million.”

If you like this story, please see our blog titled “The Top 15 Cell Culture Dish Ask the Expert Sessions in 2013

“The Big Guys Have Lost Their Iron Grip, and its all Good,” Xconomy

“Thinking about Big Pharma’s relationship with the biotech industry last week at the JP Morgan Healthcare Conference in San Francisco reminded me of an old physical education teacher I had in 7th grade. This guy was feared for his patented “pinch.” He would grab misbehaving teenage boys by the clavicle, and squeeze so hard that his thumb and index finger almost completely wrapped around the bone. He would then drag the pimply, 100-pound punk to his office for a scolding.”

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