This week’s headlines include: FDA creating innovation office to speed drug development, Drug Sponsors Urge FDA to Think Bigger About Master Protocols, Bristol-Myers Is Buying Celgene for $74 Billion in One of the Largest Big Pharma Mergers Ever, Sanofi to pay Regeneron $462 million in revised immuno-oncology deal, and 5 Biopharma Trends to Watch in 2019.

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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…

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…

A Guide for Selecting the Correct Filter Integrity Test Instrument

Selecting the right filter integrity test instrument is an important task. An informed, balanced choice will support the seamless integration of the instrument into critical processes and provide trouble-free operation for years to come. The right choice may be made more difficult by different departments, or user groups, who may assign a different value to the same feature. A rational approach is beneficial to ensure the selected instrument can fulfill all the selection criteria for all interested parties, with any compromises being limited to non-critical characteristics…

Headlines:

“FDA creating innovation office to speed drug development,” Fierce Biotech

“The FDA is creating an office of drug development science to cut the cost of bringing new medicines to patients, BioCentury reports. Staff at the office will create tools that sponsors and the FDA can use to streamline the development and regulatory assessment of drugs…”

“Drug Sponsors Urge FDA to Think Bigger About Master Protocols,” FDA News

“Leading drugmakers are urging the FDA to think bigger about its master protocol guidelines for clinical trials and expand beyond cancer trials. In September, the agency issued a draft guidance on master protocol design, hoping to encourage sponsors to use more adaptive trials and speed life-saving anticancer drugs to market…”

“Bristol-Myers Is Buying Celgene for $74 Billion in One of the Largest Big Pharma Mergers Ever,” Fortune

“Bristol-Myers Squibb agreed to acquire Celgene in a $74 billion cash-and-stock deal that unites two cancer-drug makers in one of the largest pharmaceutical-company mergers ever. Under the terms of the proposed deal, Celgene shareholders will receive one Bristol-Myers Squibb share and $50 in cash for each Celgene share held, according to a statement from the companies on Thursday. That would value Celgene at $102.43 a share, a 54% premium to the stock’s closing price on Jan 2…”

“Sanofi to pay Regeneron $462 million in revised immuno-oncology deal,” Reuters

“Sanofi will pay Regeneron some $462 million in a revision of their deal in immuno-oncology, a growing sector in healthcare research which aims to help the body’s own immune system fight cancer…”

“5 Biopharma Trends to Watch in 2019,” Genetic Engineering News

“Biopharma industry watchers, executives, and especially investors often display that same desire as a year comes to a close, which explains why there’s typically a wave of news articles and commentaries attempting to divine events of the coming year based on the 12 months that are coming to a close…”