The Dish’s Weekly Biotechnology News Wrap Up – February 1, 2019

This week’s headlines include: Japan’s approval of stem-cell treatment for spinal-cord injury concerns scientists, Celgene inks $1B deal for a preclinical epigenetic blood cancer drug from Canada, StemBioSys Kicks Off 2019 With Peer Reviewed Technology Article, Product Development and Product Expansion Plans, Takeda dengue vaccine meets main goal of trial; detailed results to come, Bayer gets with the program for Super Bowl LIII to kick off cancer testing awareness effort, FDA Announces Plans for Advancing Cell and Gene Therapies, and First child given pioneering CAR-T cancer therapy,” BBC News.

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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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…

Implementing Digital Biomanufacturing in Process Development

At this year’s Bioprocess International Conference in Boston, Dr. Thomas Seewoester, Amgen gave a very insightful and inspiring keynote presentation titled, “Bioprocessing 4.0 – Digital technologies are transforming biologics manufacturing.” In the talk, he discussed the evolution of biomanufacturing and how digital technologies were a large part of the next step forward. He reminded us that each company is moving at its own pace and that the level of digital implementation is varied across the industry. He encouraged us as an industry to think outside the box and to look at how other industries are incorporating digital technologies to see what we can apply to biomanufacturing…

Key Considerations in Gene Therapy Manufacturing for Commercialization – A panel discussion

This podcast is a recording from the panel discussion that I moderated at this year’s Cell and Gene Therapy Bioprocessing and Commercialization Conference. The discussion covers the latest in gene therapy manufacturing strategies, analytical analysis, cost of goods and key regulatory considerations…

Scalable Viral Vector Upstream Process for AAV Gene Therapy Manufacturing

Gene therapy is an exciting area of medicine that has the potential to treat a wide range of diseases for which no other treatments are available. One of the key components of successful gene therapy manufacturing is the production of the viral vectors that are used to deliver the gene of interest. Viral vector systems are by far the most widely used methods to deliver therapeutic gene products because of their infectious nature and ability to introduce specific genes into a cell…


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

BioProcess International US West is the leading phase-based bioprocessing event for advancing promising biologics towards commercial success.  Register your team to attend this year’s meeting (March 11-14, 2019 in Santa Clara, CA) to learn about today’s leading strategies to improve the speed, lower the cost and increase the quality/safety of biologics development.


Headlines:

“Japan’s approval of stem-cell treatment for spinal-cord injury concerns scientists,” Nature

“Japan has approved a stem-cell treatment for spinal-cord injuries. The event marks the first such therapy for this kind of injury to receive government approval for sale to patients. “This is an unprecedented revolution of science and medicine, which will open a new era of healthcare,” says oncologist Masanori Fukushima, head of the Translational Research Informatics Center, a Japanese government organization in Kobe that has been giving advice and support to the project for more than a decade…”

“Celgene inks $1B deal for a preclinical epigenetic blood cancer drug from Canada,” FierceBiotech

“Celgene has signed on to a deal worth about $1 billion for a Canadian preclinical asset: a first-in-class small molecule that targets protein-protein interactions and epigenetic regulation in leukemia and lymphoma…”

“StemBioSys Kicks Off 2019 With Peer Reviewed Technology Article, Product Development and Product Expansion Plans,” StemBioSys

“StemBioSys Inc. announced today that they have co-authored a paper which has been published in the peer reviewed journal Acta Biomaterialia on an innovative use of its technology. The company also announced expansion of their product offerings and outlined its product development plans for 2019…”

“Takeda dengue vaccine meets main goal of trial; detailed results to come,” Reuters

“Takeda Pharmaceutical Co said on Tuesday that its experimental dengue vaccine appears to be safe and effective at preventing all four types of the mosquito-borne disease, meeting the main goal of the Japanese drugmaker’s late-stage clinical trial…”

“Bayer gets with the program for Super Bowl LIII to kick off cancer testing awareness effort,” FiercePharma

“Bayer is going to the Super Bowl. Not with some glitzy $5 million TV ad, but instead with a print ad in the official Super Bowl LIII program to launch its new awareness campaign around genomic testing for cancer. The “Test Your Cancer” campaign soft launch begins with the Super Bowl ad along with focused digital ad buys in an effort to make people aware of genomic testing options for solid tumor cancer patients. The headline of the ad is tailored to the audience, and reads: “Cancer treatment shouldn’t be a coin toss.” Bayer’s ad appears on page three of the 292-page program—3.6 million will be printed as well as available online where the booklet is expected to receive 500 million page views—running alongside ads from big consumer brands including Samsung, Mercedes and Pepsi…”

“FDA Announces Plans for Advancing Cell and Gene Therapies,” FDANews

“In anticipation of a surge of investigational new drug applications for cell and gene therapies in the next few years, FDA Commissioner Scott Gottlieb and CBER Director Peter Marks announced plans to issue new guidance to advance their development…”

“First child given pioneering CAR-T cancer therapy,” BBC News

“An 11-year-old has become the first NHS patient to receive a therapy that uses the body’s own cells to fight cancer. Yuvan Thakkar, who has a form of leukaemia, was given the personalised treatment at Great Ormond Street Hospital (GOSH), in London, after conventional cancer treatments failed…”