The Dish’s Weekly Biotechnology News Wrap Up – April 8, 2016

April 08, 2016 Written by Brandy Sargent

This week’s biotechnology news headlines include, FDA approves biosimilar, first Gene Therapy gets recommendation for approval in Europe, Pfizer and Allergan deal fails, FDA releases draft guidance on biosimilar labeling, MedImmune and Regeneron launch cancer collaboration, Angola yellow fever outbreak, and Obama transfers Ebola funds to fight Zika.

Cell Culture Events

Ask the Expert:

Culturing airway cells using advanced 3D culture systems for modeling the human airway

The ability to appropriately model the human airway has been greatly impacted by the development of specialized in vitro cell culture techniques that promote the formation of 3D structures recapitulating the morphological and functional characteristics of the airway. Last week’s post Cool Tools – Producing 3D Tissue Models of the Airway Epithelium with PneumaCult detailed the ways in which airway tissue models contribute to the respiratory research field, and how these advanced culture systems are supported by the defined and bovine pituitary extract-free PneumaCult™ culture system. This article discusses the features of the air-liquid-interface (ALI) culture system, which supports extensive cellular differentiation to form a pseudostratified mucociliary epithelium featuring mucus-producing cells, ciliated cells with coordinated cilia movement, and physiological epithelial barrier function. Sphere cultures of airway epithelial cells incorporating a differentiated epithelial cell layer with an open lumen lined with the apical cell surfaces were also discussed in the context of an airway culture model that is easily adaptable to high-throughput investigations. Have questions about modeling the human airway? This week, Dr. Juan Hou will be answering your questions about modeling the human airway, including how to use PneumaCult™-Ex and PneumaCult™-ALI to generate high-quality ALI and sphere cultures. If you have any questions about culturing airway cells using advanced, 3D culture systems, Dr. Hou would be happy to address these, along with any inquiries on how these culture techniques can be applied to various research topics in the respiratory field.

Webinars:

Taking control of glycosylation – In vitro Glycoengineering

Thursday, April 14, 2016, 11:00am EST Overview and Session Highlights: Glycosylation has the potential to make or prevent market entry of a drug. Unlike the limited manipulation drug fermentation, in vitro glycoengineering enables the creation of high levels of galactosylation or sialylation to unambiguously select and implement the structure with the best therapeutic and pharmacokinetic profile. Roland Dorn (Roche Custom Biotech IPM), and Marco Thomann (Roche Pharmaceuticals) will share insights on:

Criteria to assess applicability of in vitroglycoengineering (IVGE) in development and manufacturing of bio-pharmaceuticals
Integration of IVGE into the downstream process
1-pot reaction: combination of galactosylation and sialylation in one reaction
Scale-ability of IVGE reaction
Case studies from Roche Pharma

To Register:Please visit please visit the webinar dedicated microsite or the Custom Biotech website. If you are not able to join the webinar, you are welcome to register here and view the webinar on demand at a more convenient point in time.

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. Register Now.

Conferences:

April

Cell Line Development and Engineering –April 11-13 2016, Vienna, Austria http://www.informa-ls.com/event/CellLine16 Bioprocess International European Summit – April 11-14, 2016 – Vienna, Austria http://www.informa-ls.com/event/BPI2016 PEGS Boston – April 25-29, 2016 – Seaport World Trade Center – Boston, MA http://www.pegsummit.com/ Interphex – April 26-28, 2016 Javits Center, New York City http://www.interphex.com/

May

TIDES – May 9-12, 2016 – Long Beach, CA http://www.ibclifesciences.com/TIDES/overview.xml 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 http://www.terrapinn.com/conference/world-cord-blood-congress-europe/index.stm World Precision Medicine – May 18-19, 2016 – London, UK http://www.terrapinn.com/conference/world-precision-medicine-congress/index.stm ISCT – May 25-28, 2016 – Singapore http://www.celltherapysociety.org/?page=ISCT2016 Cell Culture World Congress USA – May 19-20, 2016 – Hilton San Diego Resort and Spa – San Diego, CA http://www.terrapinn.com/conference/cell-culture-world-congress-usa/index.stm

June

BIO International Convention – June 6-9, 2016 – San Francisco, CA http://convention.bio.org/ Cell Line Development & Engineering – June 13-15, 2016 – 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 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 http://www.isscr.org/home/annual-meeting/san-francisco-2016 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. http://www.subramanian.org.uk/ Viral Safety and Raw Materials – June 2016, Vienna, Austria http://www.informa-ls.com/event/empoweredantibodies15

Headlines

“FDA approves biosimilar to J&J’s Remicade for multiple diseases,” Reuters

“The U.S. Food and Drug Administration (FDA) on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade, to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine.” If you like this story, please see our blog titled “BPI West 2016 – BioProcess International Conference – In case you missed it!”

“Europe gives green light to first Gene Therapy for children,” Reuters

“The world’s first life-saving Gene Therapy for children, developed by Italian scientists and GlaxoSmithKline, has been recommended for approval in Europe, boosting the pioneering technology to fix faulty genes.” If you like this story, please see our blog titled “Cool Tool – A Xeno-free Culture System for hMSC Isolation and Expansion”

“Pfizer Faces Limited Options After Its Dead Deal With Allergan,”The New York Times

“Two years ago, the pharmaceutical giant tried — and failed — to take over the British rival AstraZeneca in a bid to become the world’s largest drug company and lower its tax bill in the process. On Wednesday, Pfizer said another big overseas merger had failed, this time a $152 billion merger with Allergan, after the Obama administration introduced rules that would make the deal much less attractive.” If you like this story, please see our blog titled “Cool Tool – New ACF Medium to Expand and Differentiate Human Hematopoietic Cells into Erythroid Cells”

“FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product.” If you like this story, please see our blog titled “2015 FDA New Drug Approvals – 13 Biologics Receive Approval”

“MedImmune, Regeneron Launch Cancer Collaboration,” Genetic Engineering News

“Regeneron Pharmaceuticals said today it will use MedImmune’s pyrrolobenzodiazepine (PBD)-based “warhead” and linker technology to produce antibody–drug conjugates (ADCs) as potential cancer treatments.” If you like this story, please see our blog titled “Cool Tool – Producing 3D Tissue Models of the Airway Epithelium with PneumaCult™”

“WHO fights Angola yellow fever outbreak, global vaccine shortage,” Fierce Vaccines

“While much of the world is focused on the explosive Zika outbreak, a similar virus is spreading in Angola with lethal consequences.” If you like this story, please see our blog titled “Cool Tools – BrainPhys™: A New Way to Culture Neurons”

“Obama Administration to Transfer Ebola Funds to Zika Fight,” The New York Times

“In an effort to break the two-month deadlock over funding to fight the encroaching Zika virus, Obama administration officials announced on Wednesday that, as congressional Republicans had demanded, they would transfer $510 million originally intended to protect against Ebola to the Zika battle.” If you like this story, please see our blog titled “Enabling High Density Cell Banking using a Single-Use, Closed-System”