This week’s headlines include: Things could get hairy at FDA if shutdown continues: analysts, Samsung Bioepis biosimilar to Roche’s Herceptin wins FDA nod, Sigilon, MIT Collaborating to Develop Programmable Cell Therapies for Hemophilia, Other Diseases, EU licence granted for Erleada in prostate cancer, Scientists make gene-edited chickens in bid to halt next pandemic, and Orchard Therapeutics Plans 3 Approval Submissions, In-House Manufacturing by 2021.

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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

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…

T Cell Media: A Comprehensive Guide to Key Components

With the recent surge of cellular T cell-based immunotherapies, more and more researchers are taking an interest in these specialized immune cells. Whether you are brand new to the field or an experienced immunologist, learning to work with a new cell type can often feel overwhelming. In this guide, we will explain the ins and outs of culturing T cells, so you can spend less time searching for answers and more time making discoveries…

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…

Rapid Characterization of Virus Like Particles Informs Vaccine and Gene Therapy Downstream Processes

When working with viral systems, either during manufacture of viral-based vaccines or gene therapies, having the right analytics is crucial. This is particularly true when optimizing downstream processes and in characterizing product lots for purity. Information on the amount of virus like particles present, particle structure and their biological impact not only informs the manufacturing process, but also final product purity and quality. While these answers are important they are not always easy to access. The following case study demonstrates the use of the MiniTEM as a convenient analytical, direct-measurement method to characterize virus like particles (VLPs) or virus preps. While this case study focuses on influenza vaccine, it is important to note that this is just one example and that the technology could be used in many viral-based vaccine or viral vector manufacturing scenarios…

Headlines:

“Things could get hairy at FDA if shutdown continues: analysts,” FierceBiotech

“The FDA is still holding it together during the longest government shutdown in history but could face big problems if it continues for another month and user fees dry up. That’s according to two FDA experts cited by analysts at Jefferies, who suggest that in a few weeks reviews could come to a halt, affecting dozens of drug applications and potentially creating a “growing backlog” of delayed programs…”

“Samsung Bioepis biosimilar to Roche’s Herceptin wins FDA nod,” Reuters

“The U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment, Herceptin. The biosimilar, Ontruzant, is sold by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and is developed by Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc…”

“Sigilon, MIT Collaborating to Develop Programmable Cell Therapies for Hemophilia, Other Diseases,” Hemophilia News Today

“Sigilon Therapeutics and the Massachusetts Institute of Technology will work together to develop programmable cell therapeutics for the treatment of hemophilia, lysosomal storage diseases, and other serious chronic illnesses.The collaboration will combine Sigilon’s proprietary cell technology with synthetic biology approaches developed by Ron Weiss, PhD, a professor at the MIT Synthetic Biology Center…”

“EU licence granted for Erleada in prostate cancer,” PharmaTimes Online

“Janssen’s new treatment for prostate cancer Erleada (apalutamide) has been licensed by the European Commission (EC). Erleada has been licensed to treat men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease…”

“Scientists make gene-edited chickens in bid to halt next pandemic,” Reuters

“British scientists are developing gene-edited chickens designed to be totally resistant to flu in a new approach to trying to stop the next deadly human pandemic.The first of the transgenic chicks will be hatched later this year at the Roslin Institute at the University of Edinburgh in Scotland, said Wendy Barclay, a professor of virology at Imperial College London who is co-leading the project…”

“Orchard Therapeutics Plans 3 Approval Submissions, In-House Manufacturing by 2021,” Genetic Engineering News

“Over the next three years, Orchard Therapeutics plans to file for U.S. and European regulatory approvals for three of its gene therapies and begin manufacturing its own products at the Fremont, CA, site it recently agreed to lease, president and CEO Mark Rothera told GEN…”