This week’s headlines include, breakthrough in stem cells, new center established for stem cell genomics, study shows breakthrough therapy designation meets goals, more deal-making from drug makers in 2014, EMA approves more drugs in 2013 than FDA, pandemic vaccine deals, mice retinas repaired using stem cells.

Cell Culture Events

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.

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

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:

“Scientists Hail Breakthrough in Embryonic-like Stem Cells,” Reuters

“In experiments that could open a new era in stem cell biology, scientists have found a simple way to reprogram mature animal cells back into an embryonic-like state that allows them to generate many types of tissue. The research, described as game-changing by experts in the field, suggests human cells could in future be reprogrammed by the same technique, offering a simpler way to replace damaged cells or grow new organs for sick and injured people.”

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

“Tufts Study: Data Suggest Breakthrough Therapy Designation Meets Goals, BioWorld“

“Nearly 18 months after its launch by the FDA, the breakthrough therapy designation (BTD) is showing the potential to meet the agency’s stated goal of speeding the development and review of drugs that show early evidence of offering substantial improvement over existing therapies on a clinically significant endpoint. By approving only 30 percent of the first 113 BTD requests submitted, the FDA demonstrated the program offers meaningful differentiation from other review processes, including priority review, fast track and accelerated approval, according to the Tufts Center for the Study of Drug Development (CSDD), which conducted an assessment of the BTD program.”

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

“Analysis: Replay of Energetic Deal-making Seen for Drug Makers in 2014,” Reuters

“The torrid pace of deals in the pharmaceutical and biotechnology sectors through 2013 is not expected to let up this year, thanks to new technologies to address unmet medical needs. Between 2011 and 2016, patents in developed markets will expire on brand-name drugs that would otherwise have generated sales of $127 billion, according to data firm IMS Health. To replace some of the lost revenue, larger drugmakers are looking to bring in new products, often in areas of significant scientific advancement such as treatments for cancer, rare diseases and drugs designed to turn off the activity of rogue genes. Much of the breakthrough science is coming from biotechnology, meaning drugs derived from living cells.

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”

“EMA Trounces FDA in 2013 Drug Approval Tally: 81 vs. 27,” BioWorld

“The European Medicines Agency (EMA) outstripped the FDA in 2013, approving 81 drugs compared to the 27 approvals handed out by the FDA. This was also a notable increase on 2012, when 57 products made it past the European regulator. However, the EMA also signaled that this upward trend will not continue, since it started work on only 79 new applications in 2013, down from 95 in 2012.”

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

“Biotech’s Trumpet Pandemic Vaccine Deals and Data as the H7N9 Bird Flu Threat Grows,” Fierce Vaccines

“After a summer lull, the H7N9 bird flu virus is once again spreading across China, with a recent surge in activity pushing the total number of cases past the 200 mark. With evidence of human-to-human transmission also mounting, the need for effective vaccines is growing.”

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

“$40M Establishes New Center for Stem Cell Genomics in Bay Area, SD,” Xconomy

“The California Institute for Regenerative Medicine today awarded $40 million to create a new Center of Excellence in Stem Cell Genomics, to be led by Stanford University molecular geneticist Michael Snyder and including major research groups in San Diego, Santa Cruz, and Palo Alto. Snyder was at the center of an important paper published in 2012 that offered an outline of how the emerging field of personalized medicine could develop. In sequencing all 6 billion bases of Snyder’s own genome, scientists determined he was genetically at risk for type 2 Diabetes.

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

“Researchers Repair Retinas in Mice with Virus-free Stem Cells,” Fierce Biotech Research

“Human induced pluripotent stem (iPS) cells have been lauded for their ability to differentiate into any type of cell in the body, making them extremely promising for the treatment of countless diseases. But engineering these stem cells involves using viruses, which can be harmful to healthy tissue in the body. Now, Johns Hopkins researchers have developed a safer way to make human iPS cells, and using these cells, they’ve successfully repaired damaged retinal vascular tissue in mice.”

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