The Dish’s Weekly Biotechnology News Wrap Up – May 15, 2015
This week’s biotechnology news headlines include, hunt for AIDS cure, drug prices, cystic fibrosis drug wins key approval, greater gender equity in clinical trials, biosimilars policy, heart and diabetes genetic screens, and West Nile virus enters clinical trials.
Cell Culture Events
Ask the Expert: Directed Differentiation of Pluripotent Stem Cells
The promise of human pluripotent stem cells will be realized only when these cells are successfully coaxed into different cell types found in the human body, through the process of directed differentiation. This is critical to getting the desired cell types and numbers needed for drug screening, translational Cell Therapy and regenerative medicine applications. Most of the existing methods of differentiation are suboptimal, involving laborious mechanical and manual steps leading to issues of reproducibility and reduced efficiency in downstream processing of functionally mature lineages. The complex developmental process of differentiation and the challenges associated need to be efficiently deciphered in order to successfully direct the hPSC differentiation to target cell types.
During this Ask the Experts session, we will be discussing the challenges associated with hPSC differentiation to neural, cardiac, and definitive endoderm lineages, how Thermo Fisher Scientific can address how these processes can be efficiently simplified with tools and cGMP cell culture media systems for robust, efficient and scalable differentiation of these two critical cell lineages. Use of these reagent systems will enable researchers to precisely control and direct the differentiation to terminal lineages in a relatively easy manner, and speedily with high efficiency.
This Ask the Expert session is sponsored by Thermo Fisher Scientific and hosted by Dr. Mohan C Vemuri. Dr. Vemuri is the Director of Research and Development for Cell Biology at Thermo Fisher Scientific. In this capacity, Dr. Vemuri leads R&D activities in stem cell product development in the areas of human iPSC, adult stem cells, immune cells and cell lineage specific differentiation in GMP environment for research use and subsequently for use in Cell Therapy with regulatory compliance.
Session Starts Monday!
“Insights into Recent Developments in Protein A Chromatography,” May 20, 2015
Protein A-based chromatography is the primary method used to purify monoclonal antibodies (MAbs). Over the past decade, there has been a significant development of protein A media, giving both higher capacity and improved stability to meet the changing requirements of the industry.
- Key performance characteristics of protein A media that are critical to achieving good process economy.
- How to increase productivity through process improvements.
- Gain insights into future developments planned for protein A-based purification of MAbs.
Register here – http://www.biopharminternational.com/bp/proteina
High Performance Tour 2015
Discover how to improve efficiency and productivity for your bioprocessing workflows during our exclusive High Performance Tour.
Learn how the choice of chromatography media (resins), hardware, and services can dramatically affect your process performance.
Register now to reserve your seat at this special event where you can gain insights in improved process efficiency and productivity.
Coming to these Cities:
- Boston, MA – June 3, 2015
- Philadelphia, PA – June 5, 2015
- Raleigh-Durham, NC – June 22, 2015
- San Diego, CA – September 15, 2015
- San Francisco, CA – September 17, 2015
- Cell Line Development & Engineering – May 18-20, 2015 – Parc 55 Wyndham San Francisco, CA http://www.ibclifesciences.com/CellLine/overview.xml Co-located with Bioconjugates: From Targets to Therapeutics – http://www.ibclifesciences.com/Bioconjugates/overview.xml and Next Generation Protein Therapeutics Summit – http://www.ibclifesciences.com/ProteinSummit/overview.xml
- 10th Annual World Stem Cells and Regenerative Medicine Conference 2015 – May 20-22, 2015 – Business Design Centre, London, UK Scaling up, commercialization and collaboration for market access.
- Cord Blood World Europe Congress 2015 – May 20-21, 2015 – Business Design Centre, London, UK Build deposits, reduce costs, retain quality, decrease volume and increase utilization.
- ISCT – May 27-30, 2015 – Caesars Palace Hotel, Las Vegas, NV http://www.isct2014.com/
- Cell Culture World Congress USA – http://www.terrapinn.com/conference/cell-culture-world-congress-usa/index.stm Americas Antibody Congress http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52321.stm World Biosimilar Congress http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52322.stm Downstream Processing World http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52323.stm May 27-28, 2014 – Marriott San Diego Mission Valley – San Diego, CA
- Empowered Antibodies Congress 2015 – June 17 – 18 2015, Barcelona, Spain http://www.informa-ls.com/event/empoweredantibodies15
- Annual Meeting of the International Society for Stem Cell Research – June 24-27, 2015, -Stockholm, Sweden http://www.isscr.org/home/annual-meeting/isscr2015
- BIO International Convention – June 15-18, 2014 – Philadelphia, PA http://convention.bio.org/
- Viral Safety and Raw Materials Congress – June 24-25, 2015 – Austria Trend Hotel Savoyen – Vienna, Austria http://www.informa-ls.com/CQ3546VSRMCONGRESScellcultureJoin us at this year’s Viral Safety and Raw Materials Congress taking place in Vienna on the 24th-25th June to network and exchange with leading industry representatives, regulatory bodies and top level technology providers from across the globe to discuss and debate the latest trends in this changing sector.Packed with case studies, interactive tutorials, discussion panels and workshops, the conference agenda will provide you with key take home messages to benchmark your businesses’ strategies with regards to safeguarding against viral contamination enhancing the quality of your products.Covering all the key topics within the field of viral safety for biologics and raw materials, hear the latest on next generation detection technologies, supplier auditing, risk assessment techniques and raw material analytics from leading players including Roche, Genzyme, Sanofi Pasteur, Crucell and Abbott.For more information, please visit the event website: www.vsrm-congress.com (please hyperlink to: http://www.informa-ls.com/CQ3546VSRMCONGRESScellculture)
- The Bioprocessing Summit – August 3-7, 2015 – Westin Copley Place – Boston, MA http://www.bioprocessingsummit.com/
“Hunt for AIDS cure accelerates as GSK and U.S. experts link up,” Reuters
“Britain’s GlaxoSmithKline, which decided last week to retain rather than float off its HIV drugs business, is to collaborate with U.S. scientists in developing a cure for AIDS.”
If you like this story, please see our blog titled “Continuous Downstream Processing – A Tool to Address Key Manufacturing Challenges”
“Cost Barrier to Medicines,” The New York Times
“Re “Runaway Drug Prices” (editorial, May 5): If you are truly concerned about the problems faced by patients seeking access to needed medicines, you would do well to explore the insurance industry’s recent expansion of the use of specialty tier cost-sharing, in which patients must pay a relatively high percentage of their drug costs rather than a flat co-payment.”
If you like this story, please see our blog titled “Improving Continuous Process Efficiencies Through Development of a High-Performing Perfusion Media”
“Vertex wins key approval for cystic fibrosis treatment,” The Boston Globe
“An experimental cystic fibrosis therapy developed by Vertex Pharmaceuticals Inc. won key backing Tuesday from a panel of independent medical experts, paving the way for the Food and Drug Administration to approve it for use by 8,500 US patients.”
If you like this story, please see our blog titled “A New Model for Continuous Processing in Downstream Purification”
“Legislation Calls for FDA to Ensure Expedited Drugs are Safe for Women,” Regulatory Focus
“New legislation introduced last week in the House of Representatives would require greater gender equity in some clinical trials overseen by the US Food and Drug Administration (FDA).”
If you like this story, please see our blog titled “Materials and Assay Systems Used for 3D Cell Culture”
“GOP Senators Request FDA Clarification of Biosimilars Policy,” FDA News
“Republicans on the Senate HELP Committee are taking the FDA to task for failing to shore up policies on biosimilar naming and interchangeability before approving the first biosimilar drug nearly two months ago.”
If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”
“Montreal Institute and AstraZeneca Work on Heart and Diabetes Genetic Screens,” Genetic Engineering News
“The Montreal Heart Institute (MHI) agreed to collaborate with AstraZeneca to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications, and treatment outcomes. The goal is to drive understanding of the biologic mechanisms underlying these conditions and their complications and to uncover which genetic traits are linked to better treatment outcomes.”
If you like this story, please see our blog titled “Closed Systems in Biomanufacturing Offer A Variety of Benefits”
“NIH-backed West Nile candidate enters PhI trials at Duke,” Fierce Vaccines
“Despite years of efforts from academia and the industry, including Merck ($MRK), no FDA-approved West Nile virus vaccine exists. Scientists from Oregon Health & Science University (OHSU) are looking to change that.”
If you like this story, please see our blog titled “Cool Tool – Cedex Bioprocess Analyzers for Vaccine Manufacturing”