This week’s headlines include, drug companies join with NIH to fight major diseases, Europe’s stem cell bank consolidates, biotech IPO boom continues, stem cells ruled to be regulated as drugs, 2014 looking short on blockbusters, and Pfizer breast cancer drug succeeds in mid-stage trial.
Cell Culture Events
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.
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
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.
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.
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
“Drug Companies Join NIH in Study of Alzheimer’s, Diabetes, Rheumatoid Arthritis, Lupus,” The Wall Street Journal
“Ten big drug companies that have spent billions racing one another to find breakthroughs on diseases like Alzheimer’s have formed an unusual pact to cooperate on a government-backed effort to accelerate the discovery of new medicines. Under a five-year collaboration to be announced on Tuesday, the companies and the National Institutes of Health have agreed to share scientists, tissue and blood samples, and data. They aim to decipher the biology behind Alzheimer’s, Type 2 diabetes, rheumatoid arthritis and lupus, and to thereby identify targets for new drugs.”
If you like this story, please see our blog titled “Paper or Plastic: A Study on Single-Use Sustainability”
“Pfizer Inc’s experimental breast cancer drug significantly delayed progression of symptoms in a mid-stage trial, meeting the study’s primary goal and keeping Pfizer in the forefront of a race for a new standard of care for the disease. Pfizer shares were up nearly 4 percent on positive findings for the oral treatment, called palbociclib, one of the company’s most important experimental drugs that some analysts believe could eventually claim annual sales of more than $5 billion, if approved.”
If you like this story, please see our blog titled “The 15 Most Popular Blogs of 2013”
“Demand for induced pluripotent stem (iPS) cells threatens to outstrip supply, despite the proliferation of stem cell banking initiatives, many of which are simply too small to achieve industrial scale. Worse, the many research projects that generate iPS cells have little motivation to produce stem cell surpluses, though they could easily do so. Such surpluses would be remain idle and unproductive, since researchers typically lack the financial, technical, and human resources to distribute iPS cells to each other.”
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”
“The first 31 days of 2014 were fruitful for biotech companies going public, according to the financial services firm Burrill & Company. In a statement, the firm noted that six life-sciences companies completed public offerings last month, raising a total of $439 million. Last year was also strong for biotech initial public offerings (IPOs), with six companies completing them in September alone.”
If you like this story, please see our blog titled “2013 FDA New Drug Approvals”
“The new kind of stem cell announced yesterday may be the future of regenerative medicine, but Masayo Takahashi’s pilot safety study using a type of stem cell to treat age-related blindness is at the cutting edge. Later this year, you will make history when you begin the first ever human trial of induced pluripotent stem cells. Why is this such a big deal? Stem cells have enormous medical potential because they can become any other type of cell. If we can use them to replace old or damaged cells, this could have huge implications for treating degenerative diseases.”
If you like this story, please see our blog titled “New Study Compiles Extensive Database that Supports the Importance of Vaccination”
“Appeals Court Says Stem Cells May Be Regulated as Drugs, Affirming Low Court’s Decision,” Regulatory Focus
“The US District Court of Appeals for the DC Circuit has ruled that a lower court was correct when it ruled that the US Food and Drug Administration (FDA) could legally regulate stem cells as drugs. In July 2012, the US District Court of DC ruled that FDA may legally regulate stem cell therapies as drug products. The decision was viewed by many as an opening salvo in what was likely to be a lengthy court battle between the agency and a company accused of violating federal regulations.”
If you like this story, please see our blog titled “The Top 15 Cell Culture Dish Ask the Expert Sessions in 2013”
“Biopharma’s long-heralded return to R&D ROI may come up short this year, according to EvaluatePharma, and the next class of approved drugs features fewer blockbusters in waiting than in any of the previous four years. Looking at 5-year-out sales projections, EvaluatePharma sees just three drugs likely to cross the billion-dollar threshold: GlaxoSmithKline ($GSK) and Theravance’s ($THRX) COPD therapy Anoro Ellipta, Takeda and Lundbeck’s depression drug Brintellix, and Celgene’s ($CELG) psoriasis-treating apremilast. For comparison, 2013’s list of launched drugs had 10 blockbusters to be, and there have been at least 6 every year since 2010, according to EvaluatePharma’s report.”
If you like this story, please see our blog titled “A Review of Best Practices For Cell Culture Media Design And Processes”