This week’s biotechnology news headlines include, Sanofi and Google parent form $500 million diabetes joint venture, health care law success, Takeda advances Dengue Vaccine into Phase III, FDA, EMA, PMDA begin push for new antibacterials, Lasker Awards given for work in physiology, virology and science education, Catalent to Acquire Pharmatek, and Horizon Pharma buys rare-disease company Raptor for $800 million.
Cell Culture Events
GE Healthcare Single-use Symposium – Boston, MA – November 1-2, 2016
Tuesday, November 1, 2016-Wednesday, November 2, 2016 at 8:00 AM – 5:00 PM EST
Marriott Long Wharf, 96 State St., Boston Massachusetts 02109
Date: Wednesday, September 21, 2016
Time: 1:00 PM Central Standard Time
As Stem Cell Research moves closer toward therapeutic application, there is a recognized need to increase the quality and consistency of pluripotent stem cells and their derivatives. While variability in the efficiency of stem cell differentiation can undermine data interpretation and slow research progress, the ability to quickly monitor changes in cell phenotype without sacrificing yield continues to be a challenge. In this webinar, Richard Feurstenberg and Joy Aho discuss Luminex technology, its power as a non-invasive tool for monitoring stem cell differentiation, and its utility for troubleshooting and optimizing stem cell culturing and differentiation conditions.
Case Study: FinVector Presents Process Development and Large-Scale GMP Production of Adenovirus in the iCELLis® 500 Fixed-Bed Bioreactor
Date: Thursday, September 22, 2016
Time: 10:00 AM Eastern Daylight Time
FinVector Vision Therapies Oy (Kuopio, Finland), a contract development and manufacturing organization, has developed an iCELLis process for Phase III production of an adenovirus type 5 vector in adherent HEK 293 cells. Process development at bench-scale in the iCELLis Nano bioreactor was transferred to the large-scale iCELLis 500 bioreactor. Several consistent clinical batches have been manufactured. An Investigational New Drug Application for material made in the iCELLis bioreactor was submitted to the US Food and Drug Administration and is now in effect.
This webinar will review the design and operation of the iCELLis bioreactor and present this case study of FinVector’s process development and scale-up.
Register to Learn:
- How an iCELLis bioreactor can replace up to 786 10-layer or 278 36-layer cell culture vessels for large-scale vector production.
- Details of how FinVector developed a large-scale production process using the iCELLis platform.
- How iCELLis bioreactors control pH, DO and temperature for consistent virus production at large-scale.
Date: Thursday, September 22, 2016
Time: 02:30 PM Eastern Daylight Time
Duration: 1 hour, 30 minutes
Exosomes encapsulate and transport a wide variety of molecules generated by their cell-of-origin, a process now thought to be a form of cellular signaling. Exosome signaling is common across cell types and species, but it is of particular interest in diseases with an inflammatory component. While exosome isolation and analysis is useful to understanding the mechanisms behind these multifaceted diseases, exosomes may also be exploited for their therapeutic potential. The Scientist is bringing together a panel of experts to review the current knowledge on exosomes in inflammation, and to explore the potential for exosome-based therapeutics. Attendees will have the opportunity to interact with the experts, ask questions, and seek advice on topics that are related to their research.
Topics to be covered:
- The exosomal cargoes released during inflammation, and their potential as therapeutic targets
- How inflammatory diseases are uniquely suited to exosome analysis
Bioprocess Insights Webinars
The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the overall business strategy.
In this webinar series, four renowned subject matter experts will share their insights into four areas of bioprocessing: upstream, vaccines, downstream, and single-use technology. We will present tangible, recently developed data that can help you in developing modern, cost-efficient, and sustainable bioprocesses.
Don’t miss these on demand webinars – http://www.bioprocessintl.com/sponsored-content/bioprocess-insights-webinars/
- Bioprocessing International Co-Located with Cell Therapy Bioprocessing – October 4-7, 2016 – Boston Convention Center and Exhibition Center – Boston, MA http://www.ibclifesciences.com/BPI/overview.xml
- World Vaccine Congress Europe – October 10-12, 2016 – Barcelona, Spain http://www.terrapinn.com/conference/world-vaccine-congress-europe/index.stm
- Adoptive T-Cell Therapy Summit Europe 2016 – October 10-11, 2016 – London, UK www.tcellsummit.com
- Bioproduction – October 14-15, 2016 – Dublin, Ireland http://www.informa-ls.com/event/bio-production14
- 2nd Annual Cell & Gene Therapy Congress – November 3-4, 2016 – London, UK – http://www.celltherapy-congress.com/Over 250 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions.Over 20 presentations and case studies focused on the key issues in cell & Gene Therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing2 interactive streams:Cell & Gene Therapy: Development, Clinical Trials & CommercialisationCell Therapy Bioprocessing and ManufacturingCo-located with the established 5th Annual Cell Culture & Bioprocessing Congress and 3rd Annual Stem Cell Congress
Free Pre-Congress Webinar
Advances In Gene Editing Technologies
Presented by Richard Morgan, Vice President, Immunotherapy at Bluebird Bio. – Register for free today >>
- 5th Annual Cell Culture & Bioprocessing Congress – November 3-4, 2016 – London, UK – http://www.cellculture-congress.com/Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production4 interactive streams:Early Cell Line DevelopmentProcess DevelopmentLate Stage Cell Line Development
14 pre-scheduled one to one meetings, exhibition and informal networking opportunities
- TIDES Europe – November 14-17, 2016 – Berlin, Germany – http://get.knect365.com/tides-europe/TIDES Europe is the place where oligo and peptide experts go to meet and build successful partnerships to accelerate products from early discovery through late stage development and commercialisation. In 2015 Tides Europe attracted a 40% increase in attendance across the oligo and peptide audience.
- World Immunotherapy Congress 2016 – November 14-16, 2016 – Basel Switzerland http://bit.ly/1rbnrYy
- World Precision Medicine – November 14-15, 2016 – Washington DC
The World Precision Medicine Congress USA is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as precisionFDA and NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there.
Can you afford to miss this gathering of precision medicine leaders? Pharma, big data, and healthcare providers will be there attending sessions on Gene Therapy, Cell Therapy, personalized medicine, and genomics.
Download the brochure: http://bit.ly/1N3Y0vI
Register to attend: http://bit.ly/1ObpkNV
- ASCB – December 3-7, 2016 – San Francisco, CA http://ascb.org/meetings/
- World Stem Cell Summit & RegMed Capital Conference– December 6-9, 2016 – West Palm Beach, Florida http://worldstemcellsummit.com/
- Antibody Engineering and Therapeutics – December 11-15, 2016 – San Diego, CA http://www.ibclifesciences.com/AntibodyEng/overview.xml
- Global Biomanufacturing Summit – December 12-14, 2016 – San Diego, CA http://biomansummit.com/
“French drugmaker Sanofi (SASY.PA) and Verily, the life sciences unit of Google parent Alphabet Inc(GOOGL.O), on Monday said they would invest about $500 million in a joint venture combining devices with services to improve diabetes care, an example of growing ties between the pharma and tech sectors.”
If you like this story, please see our blog titled “Synopsis: An Interview with Audrey Jia, former FDA CMC Reviewer for Biological Products”
“Included among the many uplifting economic numbers released by the Census Bureau on Tuesday was a remarkable one about health insurance in the United States: Only 9.1 percent of Americans do not have coverage, the lowest level ever recorded by the agency. That figure is down from 13.3 percent in 2013, before the major provisions of the health care law signed by President Obama went into effect. Another government study, released last week, looked at the first part of 2016 and found that the uninsured rate had fallen even further, to 8.6 percent.
If you like this story, please see our blog titled “Utilizing UVC LEDs in Biotech and Pharma – Paving the way to better instrument design and better manufacturing methods”
“Taking the next step toward challenging Sanofi’s first-to-market Dengvaxia, on Wednesday, Takeda kicked off a global Phase III trial of its dengue vaccine, TAK-003. The announcement comes just days after the company pushed into another mosquito-borne disease, Zika, through a $312 million R&D deal with the U.S. government.”
If you like this story, please see our blog titled “Particulates in Cell Therapy Products – An important issue for commercialization”
“The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.”
If you like this story, please see our blog titled “Predicting Differentiation and Characterizing Pluripotent Stem Cells Using Non-invasive Multi-analyte Luminex® Assays”
“The Lasker Awards, among the most respected prizes in medicine, will go to six researchers who made major discoveries in physiology and virology, and to a scientist who has tirelessly promoted science education, the Albert and Mary Lasker Foundation announced on Tuesday.
If you like this story, please see our blog titled “Reduce Cell Line Development Time by 30% and Simplify Proof of Clonality – A Case Study”
“Catalent said today it plans to acquire Pharmatek Laboratories, a contract drug development and clinical manufacturing company, for an undisclosed price. Founded in 1999, Pharmatek provides dosage form development and clinical-scale cGMP manufacturing of oral, injectable, and topical products for more than 100 customers globally.”
If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”
“Horizon Pharma Plc agreed to buy Raptor Pharmaceutical Corp. for about $800 million to bolster its rare-disease treatment business and expand internationally. Horizon will pay $9 a share in cash, about 21 percent more than Raptor’s closing price on Friday of $7.45, the companies said Monday in a statement. The transaction is expected to close in the fourth quarter of 2016, and should add to earnings next year, they said.”
If you like this story, please see our blog titled “Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation”