This week’s headlines include: Regeneron forays into gene-silencing therapies with Alnylam tie-up, Most Osteoporosis Drugs Don’t Build Bone. This One Does., Sanofi turns to subscriptions to offer patients insulin at $99 per month, and UC, University of Vienna, Charpentier Granted Third European CRISPR Patent.

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

Biologic Products DNA to IND Timeline in 9 Months – Yes it can be done!

The ability to rapidly develop biologic products from conception to human clinical trials is an increasingly important aspect of controlling drug development costs and in expediting the drug’s pathway to one day provide critical treatments. Hence, there has been an increased focus on ways to shorten the timeline through product development. These expedited timelines are especially important when dealing with infectious disease control…

Using cell culture models of endocrine resistance to improve triple positive breast cancer treatment options

Gibco Cell Culture Hero, Dr. Hillary Stires discusses her work researching better treatment options for triple positive breast cancer patients. She explains how the use of cell culture modeling helps drive her research. She also talks about her experience as a cell culture hero and her passion for the scicomm movement on social media platforms…

ELISA Assay Automation Important Considerations

We recently finished our Ask the Expert discussion on “How to get the most out of automating your ELISA-like assays, dos and don’ts.” During this Ask the Expert session, we covered topics related to ELISA assay automation and ELISA-like assay automation, including assay transfer, optimization, validation, challenges, benefits and specific questions regarding data generation…

Basic Fibroblast Growth Factor—the Good, the Bad and the Stable

In order to answer this question, first let’s discuss the definition of fibroblast. Fibroblasts are the type of cell responsible for, among other things, fetal development and wound healing. They synthesize the proteins that make up all the tissues, from muscle to skin, in your body. Fibroblast growth factor, or FGF, is a protein that signals fibroblasts to divide, therefore increasing the population of fibroblasts to better heal injury, for instance. Although FGF was originally discovered by its effect on fibroblasts, it is important to note that FGF also stimulates many other types of cells…

Assay Automation – A guide to understanding the key drivers and considerations

Assay automation can improve a lab’s efficiency, throughput, data quality and permit scientists more time for non-routine tasks. The level of automation for an assay workflow can be flexible with some companies choosing to automate the entire process from sample handling to analysis. In other cases, only certain steps of the workflow may be selected for automation. Often people have the perception that complex assays benefit the most from automation, however there are good reasons to automate basic, routine assay formats as well. In this article, we will look at the benefits of automating assay workflows and also the key considerations important to deciding whether automation is right for your process…

Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process

Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include a Protein A based affinity chromatography step followed by polishing steps. The purpose of the affinity chromatography is to capture the mAb, while the polishing steps remove any remaining impurities, such as residual DNA, host cell proteins, viruses and aggregates. There are options in the selected polishing steps, but often they involve cation exchange or hydrophobic interaction. Increasingly membrane chromatography is being used as a polishing step to remove any remaining contaminants…

Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent

In today’s market, mAbs are produced for several therapeutic applications, yet they are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate; the contaminant HCP content is also process-dependent. As drug manufacturers seek to produce mAbs for various application, they are also looking to streamline processes for efficiency and quality…

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…

Professional Training:

Continuous Downstream Processing

Biofactory Competence Center, Fribourg, Switzerland, May 21-23, 2019

This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.

Headlines:

“Regeneron forays into gene-silencing therapies with Alnylam tie-up,” Reuters

“Regeneron Pharmaceuticals Inc said it would invest $800 million in Alnylam Pharmaceuticals Inc to develop treatments for eye and central nervous system diseases using gene-silencing RNA interference (RNAi) technology…”

“Most Osteoporosis Drugs Don’t Build Bone. This One Does.,” The New York Times

“The Food and Drug Administration on Tuesday approved an osteoporosis drug that represents the first new treatment approach in nearly two decades — a strategy based on a rare gene mutation in people with bones so dense that they never break…”

“Sanofi turns to subscriptions to offer patients insulin at $99 per month,” FiercePharma

“Louisiana has garnered plenty of headlines for its new “Netflix” approach to buying hepatitis C drugs. Now, Sanofi has unveiled a program that takes that model directly to patients, supplying insulin products for a flat monthly rate…”

“UC, University of Vienna, Charpentier Granted Third European CRISPR Patent,” Genetic Engineering News

“The European Patent Office (EPO) has granted a third CRISPR-Cas9 patent to the regents of the University of California (UC), the University of Vienna, and CRISPR pioneer Emmanuelle Charpentier, PhD, director and scientific member at the Max Planck Institute of Infection Biology, Berlin. EPO Patent No. 3,401,400 claims methods and compositions of using CRISPR/Cas9 to modify DNA and regulate gene activity in eukaryotic cells, including kits to carry out such work. The patent was granted March 1, but disclosed through publication by EPO on Wednesday…”