This week’s biotechnology news headlines include, EU approves TEVA-Allergan deal, Sanofi drug beats Humira in trial, FDA approves new formulation in myeloma, breakthrough therapies cut timelines, gene tests for breast cancer, Roche and Blueprint sign immunotherapy deal, and Zika vaccine timeline.
Cell Culture Events
Novel Lipid Supplement, Cell Ess, Increases Antibody Production in CHO Cells for Industrial Manufacturing Applications
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:
Are you effectively monitoring your contract lab?
Wednesday March 23, 2016, 11:00am EST
You will learn:
- Critical aspects of an effective quality agreement
- Essential elements of a comprehensive quality process
- Best practices for a successful audit process
- Strategies for obtaining qualitative and quantitative metrics reporting
Register for free at www.EurofinsLancasterLabs.com/Webinars
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 European Union said on Thursday that it had signed off on Teva Pharmaceutical Industries’ $40.5 billion deal to buy the generic drug business of Allergan after the companies agreed to sell some operations in Europe to ease competition concerns.”
If you like this story, please see our blog titled “Cool Tool – Mitigating Risk beyond Xeno-Free: Virus Stabilization during Culture and Final Formulation”
“Sanofi and Regeneron Pharmaceuticals Inc. said an experimental rheumatoid arthritis therapy helped patients more than AbbVie Inc.’s Humira in a late-stage trial.”
If you like this story, please see our blog titled “Pancreatic Progenitor Cells – High Efficiency Differentiation and Generation”
“The FDA has approved Captisol-enabled (CE) melphalan (Evomela) as a high-dose conditioning treatment for use in patients with multiple myeloma prior to autologous stem cell transplantation (ASCT), as well as for the palliative treatment of patients with myeloma for whom oral therapy is not appropriate, according to a statement from the developer of the drug, Spectrum Pharmaceteucials.”
If you like this story, please see our blog titled “3D Bioprinting and 4D Bioprinting – Applications and Technologies”
“A nonprofit cancer advocacy group says that the US Food and Drug Administration’s (FDA) breakthrough therapy designation has been effective in shortening the amount of time it takes to develop new oncology drugs by more than two years.”
If you like this story, please see our blog titled “2015 FDA New Drug Approvals – 13 Biologics Receive Approval”
“At a time when genetic testing and genetically personalized treatments for cancer are proliferating, buoyed by new resources like President Obama’s $215 million personalized medicine initiative, women with breast cancer are facing a frustrating reality: The genetic data is there, but in many cases, doctors do not know what to do with it.”
If you like this story, please see our blog titled “Cool Tool – New Robust Kit for Efficient Generation of Functional Pancreatic Progenitor Cells”
“Blueprint Medicines is collaborating with Roche on the discovery, development and commercialisation of up to five targeted cancer immunotherapies, in a deal potentially worth more than $1 billion.”
If you like this story, please see our blog titled “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”
“In a similar situation to the Ebola epidemic, the World Health Organization warns that any Zika vaccine may be developed too late to address the current epidemic. However, that isn’t stopping work at the NIH and CDC, which are pleading for emergency funding so Zika research can progress and research in other areas doesn’t get sidelined.”
If you like this story, please see our blog titled “Enabling High Density Cell Banking using a Single-Use, Closed-System”