This week’s headlines include: The FDA has five weeks till money runs out for approving new drugs, FDA Fast Tracks Oral Antibiotic for C difficile Treatment, Amgen’s once-dismissed osteoporosis drug Evenity ‘back in the game’ after rosy FDA panel vote, Sanofi to Develop Biomunex Bi-, Multi-Specific Antibodies for Immuno-Oncology and Other Areas,and Sen. Sanders, Rep. Cummings introduce bill to lower U.S. drug prices.

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

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…

Cell Harvesting Technologies – Which is best for your process?

Cell harvesting is a critical step in connecting upstream monoclonal antibody production with downstream purification. Selecting the best cell harvesting technology based on the characteristics of the cell culture process can be challenging. This decision is made early in process development and requires a good understanding of both the current process and the advantages/disadvantages of the various cell harvesting technologies available…

Large Scale Adenovirus Production for Gene Therapy Manufacturing

Gene therapy is one of the most promising developments in medicine. It has the potential to treat many diseases by using a gene-modifying technology to repair, replace or correct genetic damage in the body. Last year was an important year for advancing gene therapy with two pioneering Chimeric Antigen Receptor T Cell (CAR T) cell therapies for cancer approved in the US: Novartis’ Kymriah^® and Kite/Gilead’s Yescarta^® and Spark’s Luxturna^® was approved to correct a retinal disease…

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:

“The FDA has five weeks till money runs out for approving new drugs,” CNN

“The US Food and Drug Administration has roughly five weeks of funding left to review new drug applications during the shutdown, commissioner Dr. Scott Gottlieb said Monday on Twitter…”

“FDA Fast Tracks Oral Antibiotic for C difficile Treatment,” MD Online

“The US Food and Drug Administration (FDA) has granted Fast Track designation to ACX-362E, an investigational new treatment for Clostridium difficile infection (CDI). The oral antibiotic is being developed by Acurx Pharmaceuticals, LLC, as a targeted, narrow spectrum antibiotic and has recently entered a phase 1 clinical trial…”

“Amgen’s once-dismissed osteoporosis drug Evenity ‘back in the game’ after rosy FDA panel vote,” FiercePharma

“If you thought Amgen osteoporosis candidate Evenity (romosozumab) was down for the count, think again. After an overwhelmingly positive 18-1 vote in favor of approval from an FDA advisory panel Wednesday afternoon, the drug is “back in the game,” as Jefferies analyst Michael Yee put it in a note to clients…”

“Sanofi to Develop Biomunex Bi-, Multi-Specific Antibodies for Immuno-Oncology and Other Areas,” Genetic Engineering News

“Sanofi will use Biomunex Pharmaceuticals’ proprietary BiXAb^® platform for generating and optimizing bi- and multi-specific antibodies to develop new treatments in immuno-oncology and other therapeutic areas, Biomunex said today…”

“Sen. Sanders, Rep. Cummings introduce bill to lower U.S. drug prices,” Reuters

“U.S. Senator Bernie Sanders and Representative Elijah Cummings introduced legislation on Thursday aimed at lowering the cost of prescription drugs for American consumers, critiquing President Donald Trump administration’s efforts to curb medicine prices…”