The Dish’s Weekly Biotechnology News Wrap Up – February 8, 2019

This week’s headlines include: Sanofi blood disorder drug wins FDA approval, Anti-rejection drug rapamycin shows promise in liver cancer, Roche, joining rivals, donates hemophilia drug to boost access, J&J’s Janssen to Develop MeiraGTx’s Retinal Disease Gene Therapies, and Bipartisan group of lawmakers introduces bill to fight high drug prices.

Podcasts:

Check out our podcast channel. We have over 25 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:
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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

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Expediting Cell and Gene Therapy Workflows

In this podcast and accompanying article, we interviewed Mr. Dave Eansor President of the Protein Sciences Segment at Bio-Techne and Dr. Sean Kevlahan, Senior Director of Cell and Gene Therapy at Bio-Techne about new technologies that can be implemented to expedite cell therapy and gene therapy workflows and facilitate the path from bench to clinic…

A New Dimension of Cell Culture: The Rise of Spheroid Culture Systems

In this article, we discuss the evolution of spheroid culture systems, methodologies of spheroid formation, spheroid culture challenges and relevant solutions…

A Road Map for Efficient Fed-Batch Cell Culture Optimization

In this podcast and accompanying article, we interviewed Dr. Andreas Castan, Principal Scientist at GE Healthcare Life Sciences about the most efficient ways to optimize fed-batch cell culture production for CHO-based antibodies. This included a discussion of media vs. feed strategies, incorporating critical quality attributes, evaluating the impact of optimizing on downstream processing and more…

Cool Tool – Eliminate Contamination and Improve Efficiency with Gibco™ One Shot FBS

Fetal bovine serum is a widely used cell culture media supplement for the successful in vitro culture of many cell types. FBS is a rich source of nutrients, hormones, lipids, adhesion factors in addition to acting as carriers for growth factors and supplying buffering capacity to the culture media. FBS is commercially available from many manufacturers, and because the composition of FBS is variable in its ability to support cell proliferation, customers may need to test specific batches for suitability for their specific cell type. FBS is stored at -20°C to preserve the stability of the components in serum, such as growth factors, thus the inventory management and storage of FBS can sometimes be a daunting and time-consuming task particularly where many cell types are being cultured…

Viral Vector Manufacturing for Gene Therapy – Developing a Platform Process

In this podcast and accompanying article, we interviewed Dr. Mats , Dr. Mats Lundgren, PhD Customer Applications Director, Life Sciences, GE Healthcare, Sweden about developing platform processes for viral vector manufacturing and Mats describes a recently developed platform process for adenovirus production…


The Down Stream Column

Scalable Protein A Chromatography for High-Throughput Process Development

Process development is a critical part of biomanufacturing, but it can be very time and resource intensive. With recent industry initiatives around speed to market, process development is an area that could really benefit from high throughput solutions. One high-throughput process development tool for chromatography is the use of 96-well plates. These plate platforms permit automated screening of large numbers of conditions very efficiently and use only a small amount of material for testing. This platform is great for screening but requires bridging experiments to translate results to process scale. In addition, automating the 96-well process requires investment in liquid handling equipment in order to reach the full potential of the platform…

 

Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule

Biosimilar molecules have some unique manufacturing requirements that must be taken into account when planning process development. The requirements for process development typically require a good deal of selectivity, cost-efficiency and the need to meet aggressive timelines. These lend themselves to a process development approach that incorporates high throughput…

Designing a Viral Clearance Study – A Step by Step Tutorial

Viral clearance testing is a regulatory requirement and critical part of the overall approval process for all biologics. Viral clearance testing is performed at two points in biologics development. Before Phase I clinical trials, viral clearance studies are conducted to demonstrate the capability of a downstream purification process to eliminate potential viral contaminants…

High Throughput Process Development in Biomanufacturing – Current Challenges and Benefits

Process development is and has always been a key component in successful scale-up of bioprocesses to commercial manufacture scale. At the Fourth High Throughput Process Development Conference in Toledo, Spain, several methods for high throughput process development were discussed for both upstream and downstream applications. Challenges and benefits were described along with ideas on where the industry can go from here. The proceedings were collected in a recently published report, “HTPD – High Throughput Process Development,” and include extended abstracts of talks presented at the conference. The report is very informative and I have summarized some key areas of focus in this article. We were also fortunate to be able to interview one of the conference chairs, Mats Gruvegard, GE Healthcare Life Sciences about what he saw as key takeaways from the conference and where he sees the future of high throughput process development heading…

Monolithic Chromatography Enables Process Intensification of Virus Purification

Monoliths are unique from other forms of chromatography media for several reasons. Monolith architecture consists of highly interconnected convective channels that are distributed throughout the entire bed. The large channels are easily available for purification even for large biomolecules. This unique architecture also creates a void-less space, thus significantly reducing shear and product loss. In monoliths, the mass transport is also exclusively convective and laminar which means that all solutes flow with the current regardless of size and require only a few seconds of residence time…


Conferences:

Americas Antibody Congress 2019

March 3March 5
Grand Hyatt San Diego, 1 Market Place
San Diego,CA 92101United States
+ Google Map
Americas Antibody Congress 2019

In the 14 years that the European Antibody Congress has run in Basel, Switzerland, there have been countless breakthroughs, advancements and achievements that not only were showcased for the first time at the European Antibody Congress but were also born out of collaborations and partnerships that were catalysed by, or initiated, at the European Antibody Congress. This is why we are launching the Americas Antibody Congress in San Diego this March to bring the amazing antibody work we’ve been showcasing…

Find out more »

BioProcess International West

March 11-14, 2019
Santa Clara Convention Center, Santa Clara, California, USA

BioProcess International US West

Overcome Your Upstream and Downstream Challenges at BPI US West 2019

Meet the global CMOs, CROs, suppliers and technology leaders who can accelerate your biological products to market by getting your 2-day exhibit hall pass to BioProcess International US West, held March 11-12, 2019 at the Santa Clara Convention Center in California.  Passes start at $399, but readers of Cell Culture Dish can save 50% on an exhibit hall pass when you register with VIP Code DISH50 by March 1, 2019 (new registrations only).  For full details and to register, visit https://lifesciences.knect365.com/bpi-west/exhibit-hall-pass?vip_code=DISH50&utm_source=cell-culture-dish&utm_medium=website


Headlines:

“Sanofi blood disorder drug wins FDA approval,” Reuters

“The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Sanofi SA’s drug to treat a rare blood-clotting disorder in adults in combination with standard-of-care treatments…”

“Anti-rejection drug rapamycin shows promise in liver cancer,” FierceBiotech

“Scientists at the University of Pittsburgh School of Medicine were studying the cells that surround the liver’s central vein when they made a serendipitous discovery. Cells with a mutation in a gene called β-catenin also made high levels of the mTOR protein—a fault that they believe could promote the development of cancer…”

“Roche, joining rivals, donates hemophilia drug to boost access,” Reuters

“Switzerland’s Roche will donate its new hemophilia A drug Hemlibra to a World Hemophilia Federation program, it said on Wednesday, joining rivals who also back the effort to help patients in developing countries who face treatment hurdles…”

“J&J’s Janssen to Develop MeiraGTx’s Retinal Disease Gene Therapies,” Genetic Engineering News

“Johnson & Johnson’s Janssen Pharmaceutical will partner with MeiraGTX Holdings to develop, manufacture, and commercialize its clinical-stage inherited retinal disease portfolio, the companies said today, through a global collaboration and license agreement that could generate more than $440 million for MeiraGTx…”

“Bipartisan group of lawmakers introduces bill to fight high drug prices,” Reuters

“A bipartisan group of U.S. senators re-introduced a bill on Tuesday aimed at helping generic drug companies bring out a cheaper version of pharmaceuticals…”