This week’s headlines include: Unlocking the Secrets of the Microbiome, Amgen, Novartis Expand Alzheimer’s Collaboration with New Trial, FDA Revises Priority ANDA Draft Guidance, Merck, Pfizer launch Bavencio for rare skin cancer, Lawmakers defend ‘unprecedented’ Pentagon health panel, which could undermine FDA, and Universal Flu Shot Promising Lifelong Protection Edges Closer.

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

FBS – It’s not all created equal – what consumers need to know

In this podcast and accompanying article, we interviewed Alyssa Master, Ph.D., Senior Manager of Science and Applications, Nucleus Biologics about some of the challenges of working with FBS, why not all FBS is created equal and suggestions for FBS customers who are trying to navigate these issues…

Managing Shear Stress in Biomanufacturing with the shear protectant Poloxamer 188 – A Discussion

We recently finished our Ask the Expert discussion, “Ask the Expert – Addressing Shear Stress in Bioreactors”. During this Ask the Expert session, we had questions that covered topics including factors that contribute to shear, analyzing and modeling shear stress in a bioreactor, and how to use a shear protectant to protect against shear. In addition, we had several questions related to Poloxamer 188 implementation, best practices, cell lines, qualification and media concentration level…

A Naturally Produced Extracellular Matrix that mimics stem cells’ native biochemical and structural microenvironment for improved performance

Cell and extracellular matrix interaction has been shown to play an important role in stem cell behavior and lineage differentiation, with cells’ microenvironment regulating many aspects of cell behavior…

Fed-batch culture – Optimizing feed strategies now and in the future

Great strides have been made in fed-batch culture and feed strategies with new tools and strategies introduced regularly. In addition to improving cell growth and viability, our optimization focus has grown to include strategies for influencing protein quality, such as glycosylation profiles. This article and accompanying interview will explore current feed design strategies and will look ahead to the future of fed-batch culture…

Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit

Antibody drug conjugates offer tremendous therapeutic potential and the market for ADCs is expected to expand rapidly. However, antibody-drug conjugate manufacturing presents both technological and logistical challenges…

2017 Biotech Week Boston – Downstream Coverage Highlights

Last month, Boston Biotech Week featured interesting content with a wide range of issues, from cell culture techniques to commercialization and everything in between covered. Talks focused on improving the manufacturing process for biopharmaceuticals and cell therapies, enabled industry networking opportunities, and provided the chance to see the latest products and technologies…

Cool Tool – Optimize downstream processing with single-pass inline concentration

Concentration of biological drug substances is an important step at various stages in biomanufacturing. Concentration is often necessary between chromatography steps, in post harvest, during pre-capture or for in-process volume reduction. Concentration may also be needed between chromatography steps.

During concentration applications, there is a potential for aggregation, particularly with sensitive biologics even when they are only slightly stressed. Therefore, an effective concentration system must operate efficiently under mild conditions while at the same time being flexible enough to integrate readily with different downstream operations…

Cool Tool – ‘Jetting’ technology for manufacturing agarose beads with enhanced performance characteristics

The vast majority of chromatography resins designed for large-scale bioprocess chromatography separation are produced using traditional batch emulsification in conventional stirred-tank reactors. In these cases, the size of the beads formed in the reactor is a function of the shear force generated by the impeller. The faster the impeller speed, the smaller the beads are. As a result, there is a wide particle size distribution of the manufactured beads. Furthermore screening is required to remove coarse and fine beads, which detract from column performance. This screening is extremely time consuming particularly for smaller beads (less than 65 µm). The smaller the bead being produced the lower the achieved yield so realistically one cannot make beads financially viable less than 40 µm. It also adds high costs due to the additional time in the manufacturing facility with large volumes of waste from the fine and coarse beads. Even after this screening, the resin will still have a relatively wide size particle distribution…

Webinar:

Making Virus Inactivation a Reality for Continuous Upscaled Processes

Presented by: David Johnson & Mark Schofield

Date: Thursday, November 30, 2017
Time: 8 am PST / 11 am EST

Date: Tuesday, December 5, 2017
Time: 9 am GMT / 10 am CET/ 2:30 pm IST / 5 pm CST / 6 pm JST

Duration: 1 hour

The Cadence™ Virus Inactivation (VI) system, a fully automated low pH virus inactivation system for both batch and continuous processing is one of the latest additions to Pall’s Continuous platform.  This webinar will discuss how traditional low pH virus inactivation has been translated into an automatic system, and also the additional challenges associated with making it a continuous process.  There will be a review of the two methods used for validating the design and an overview of the integration of capture chromatography and virus inactivation, which represents the first commercial scale combined unit operations in this space.

Events:

November

World Orphan Drug Congress Europe
November 13 – November 15
FAIRMONT REY JUAN CARLOS I, Av. Diagonal, 661-671
BARCELONA, 08028 Spain
The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access.

Headlines:

“Unlocking the Secrets of the Microbiome,” The New York Times

“Modern technology is making it possible for medical scientists to analyze inhabitants of our innards that most people probably would rather not know about. But the resulting information could one day save your health or even your life…”

“Amgen, Novartis Expand Alzheimer’s Collaboration with New Trial,” Genetic Engineering News

“Amgen and Novartis said today they will expand their two-year-old collaboration with the Banner Alzheimer’s Institute by launching a new Phase II/III trial designed to assess whether the oral beta-site APP-cleaving enzyme-1 (BACE1) inhibitor CNP520 codeveloped by the companies can prevent or delay symptoms in people at high risk for the memory-robbing ailment…”

“FDA Revises Priority ANDA Draft Guidance,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA)…”

“Merck, Pfizer launch Bavencio for rare skin cancer,” PharmaTimes

“Merck and Pfizer have launched in the UK of Bavencio, the first medicine to be licensed for the treatment of the rare, aggressive skin cancer of metastatic Merkel Cell Carcinoma (mMCC)…”

“Lawmakers defend ‘unprecedented’ Pentagon health panel, which could undermine FDA,” Politico

“The Defense Department — and not FDA — would have the power to approve drugs and medical devices under the defense policy bill that’s being hammered out by a conference committee, alarming congressional health staff and HHS who say it would undermine medical safety and potentially put soldiers at risk…”

“Universal Flu Shot Promising Lifelong Protection Edges Closer,” Newsweek

“A new vaccine could someday lead to potential lifelong protection against the major strains of flu, according to a new paper published in Scientific Reports on November 2. For now, however, the only ones to see the benefit of this vaccine are mice in labs at the Nebraska Center for Virology…”