This week’s biotechnology news headlines include, FDA approves Teva’s severe asthma drug, geneticist J. Craig Ventner to receive BIO award, pharma companies ask FDA to make clinical outcome assessment more valuable for researchers, Merck and Harvard to develop cancer treatments, Kite collaborates with Roche on immunotherapy, FDA proposes database to monitor CAR-T cell safety, and GSK and Miltenyi Biotec to partner on cell and gene therapies.
Cell Culture Events
Novel Lipid Supplement, Cell Ess, Increases Antibody Production in CHO Cells for Industrial Manufacturing Applications
March 29, 2016, 11:00 am to 12:00 pm EDT
Enhancing protein production is a common bioproduction goal. Cell Ess, when used to supplement to an optimized cell and media system, resulted in a 37% increase in productivity per cell. Used as a 5% feed, it resulted in a 25% increase in yield and extension of peak protein production. Our results suggest that an increase in protein production may not require a change in the metabolic state of the cells.
- How a novel media supplement for large scale bioproduction was used to significantly boost mAb protein yield as a continuous feed in a previously optimized system.
- That the supplement works in a scalable fashion from shaker flask to wave bag bioreactor
- How one can increase protein yield without increasing biomass, i.e. fewer cells become more efficient producing the engineered protein of interest.
Who Should Attend:
- Those in early development of bioproduction of proteins in eukaryotic cells
- Those in media optimization or yield optimization for scaled bioproduction of proteins
- Department Directors, Program Directors, Project leaders, involved in optimization of large scale bioproduction of proteins.
Dr. Adam Elhofy, Ph.D., CSO, Essential Pharmaceuticals
Dr Elhofy developed the core technology for the Ess line of products and aided in creating patents around novel uses of materials. Dr. Elhofy has over 14 years of scientific research experience in the areas of immunology, neuroscience, and oncology. He was funded by both the National Institutes of Health and the Multiple Sclerosis society as an investigator at Northwestern University Medical School. His doctoral research won him the award of the Top 5 trainee scientists by the American Association of Immunologists. Dr. Elhofy has 14 scientific publications in peer reviewed journals. He has played a variety of roles with start-up biotech companies ranging from Principal Investigator to Director of Corporate Development.
Be in or be out: continuous processing of biopharmaceutical proteins
FREE webinar with live Q&A session
Wednesday 30 March 2016
Senior Director Strategic Customer Relations
Günter’s experience from the bioprocessing industry stretches over more than 30 years. He has held senior management positions at GE Healthcare in Sales, Marketing, and R&D. In 2012, he received the BioProcess International Award as “Thought Leader of the Decade”, for Downstream Processing.
Continuous processing from cell culture through to drug substance offers numerous advantages compared with a process based on batch unit operations. Floor space requirements in classified areas can be significantly reduced; the cost load in equipment is much lower as many unit operations can be down-sized; and the product quality can be improved when a process is run in steady-state. Furthermore, continuous processing can enable production of proteins that are unstable, toxic, or difficult to express. On the downside, the risk profile of a long running time with extended requirements for cell line and equipment stability, potential contamination or other reasons for failure can be considered higher. Finally, the cost of goods sold for batch processes in today’s biomanufacturing environment is decreasing to low double digit USD levels per gram. How does this fact affect the case for continuous processing?
Join us for this one hour webinar and learn about:
- The next-generation biomanufacturing facilities.
- Insight into current state of continuous processing and predictions for the future.
- Pros and cons for continuous processing.
- Innovations such as periodic counter-current chromatography, which drive the adoption of continuous downstream processing.
There will be a live Q&A session at the end of the webinar.
Choose from one of three available time slots:
Bioprocess Insights Webinar Series:
Upstream – How to Improve Productivity and Process Economy Through Intensified Seed Train Strategies
Wed, Apr 20, 2016 – Time:11:00 AM EDT – Duration:30 minutes
Dr. Andreas Castan will discuss the upstream seed train and will show how a process intensification strategy can be used to compress timelines and decrease the cost for this unit operation.
World Vaccine Congress – March 29-30, 2016 –Grand Hyatt– Washington D.C.
Cell Line Development and Engineering –April 11-13 2016, Vienna, Austria
Bioprocess International European Summit – April 11-14, 2016 – Vienna, Austria
PEGS Boston – April 25-29, 2016 – Seaport World Trade Center – Boston, MA
Interphex – April 26-28, 2016 Javits Center, New York City
TIDES – May 9-12, 2016 – Long Beach, CA
World Stem Cells Regenerative Medicine Conference – May 18-20, 2016 – London, UK http://www.terrapinn.com/conference/stem-cells/index.stm
World Cord Blood Conference – May 18-19, 2016 – London, UK
World Precision Medicine – May 18-19, 2016 – London, UK
ISCT – May 25-28, 2016 – Singapore
Cell Culture World Congress USA – May 19-20, 2016 – Hilton San Diego Resort and Spa – San Diego, CA
BIO International Convention – June 6-9, 2016 – San Francisco, CA
Cell Line Development & Engineering – June 13-15, 2016 – Parc 55 Wyndham San Francisco, CA
Bioconjugates: From Targets to Therapeutics – http://www.ibclifesciences.com/Bioconjugates/overview.xml
Next Generation Protein Therapeutics Summit – http://www.ibclifesciences.com/ProteinSummit/overview.xml
Annual Meeting of the International Society for Stem Cell Research – June 22-25, 2016, San Francisco, CA
Progress in Continuous Biomanufacturing – June 27-28, 2016 – Robinson College, Cambridge, UK
The conference is enhanced by the participation of several leading industrial technologists, scientific, vendors and also leading academics from Europe and USA. They have come forward to share their experience and knowledge to provide a better understanding of the current technologies and their application in continuous biomanufacturing. There is also a plenary lecture by a distinguished professor in the field of bioprocessing, and you will also benefit from access to unpublished data. This meeting will address several advancements and their successful application with data in the Technology both Upstream and downstream and also on Initiatives to process developments and project to the future direction of the industry. By joining with us you can benefit from the current state of-the-art advancements in continuous manufacturing and also learn about the successful organisations that are developing and applying these methods in-house.
Viral Safety and Raw Materials – June 2016, Vienna, Austria
“The U.S. Food and Drug Administration said on Wednesday it had approved Teva Pharmaceutical Industries Ltd’s drug to treat asthma in adults who have a history of severe attacks despite taking medication.”
If you like this story, please see our blog titled “Cool Tool – Mitigating Risk beyond Xeno-Free: Virus Stabilization during Culture and Final Formulation”
“Washington D.C.-based Biotechnology Innovation Organization (BIO), the largest biotech trade group in the world, has named La Jolla geneticist J. Craig Venter as the recipient of its 2016 George Washington Carver Award for innovation in industrial biotechnology.”
If you like this story, please see our blog titled “Pancreatic Progenitor Cells – High Efficiency Differentiation and Generation”
“Pharma Companies Call on FDA to Make Clinical Outcome Assessment Pilot More Useful,” Regulatory Focus
“More than a dozen drug developers, including Pfizer, Genentech, Sanofi and GlaxoSmithKline, and industry groups are calling on the US Food and Drug Administration (FDA) to ensure that a clinical outcome assessment (COA) pilot program includes more useful information for researchers”
If you like this story, please see our blog titled “3D Bioprinting and 4D Bioprinting – Applications and Technologies”
“Harvard University will partner with Merck & Co. to develop small-molecule treatments for acute myeloid leukemia (AML) and other cancers, in a $20 million-plus collaboration announced today.”
If you like this story, please see our blog titled “2015 FDA New Drug Approvals – 13 Biologics Receive Approval”
“Kite Pharma, Inc. announced that it has entered into a collaboration agreement with Roche Holding’s Genentech for its immunotherapy candidate, KTE-C19.”
If you like this story, please see our blog titled “Cool Tool – New Robust Kit for Efficient Generation of Functional Pancreatic Progenitor Cells”
“The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells.”
If you like this story, please see our blog titled “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”
“GlaxoSmithKline (GSK) and Miltenyi Biotech said they will partner to develop new cell and gene therapies through a collaboration whose value was not disclosed.”
If you like this story, please see our blog titled “Enabling High Density Cell Banking using a Single-Use, Closed-System