This week’s headlines include: House E&C Subcommittee Advances 5 Bills Related to Generic Competition, Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny — Again, First gene therapy to treat rare blood disease nears European approval, AveXis to Acquire AstraZeneca Manufacturing Site in Longmont, CO, and Scientists Thought They Had Measles Cornered. They Were Wrong.,” The New York Times

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

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…

Increased CHO Transfection Efficiency and Production in a Straight Forward System

Transient protein production enables quick and efficient production of milligram to gram quantities of recombinant protein, which saves time and cost compared to developing a genetically stable cell line for use in bioproduction. This is particularly important in drug development where preclinical material is needed quickly in order to make informed go/no go decisions. Having access to preclinical material faster can greatly impact the overall drug development timeline. The challenge has been low transfection efficiency and productivity, particularly in CHO cells. CHO cells are typically more difficult to transfect, but are the preferred vehicle of antibody production due to their use in larger scale production of clinical material…

Keys to successful single-use bioreactor scale up – from small scale to pilot scale

Successful monoclonal antibody (mAb) manufacturing relies on good process development and reliable bioreactor scale up. Initial process development work is typically conducted at small scale, then moved to bench scale and lastly to pilot scale before moving into manufacturing. One of the biggest challenges is scaling up an optimized process from process development to manufacturing scale. Just a small change in the size of the bioreactor can have a cascade effect on many other culture conditions…

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:

“House E&C Subcommittee Advances 5 Bills Related to Generic Competition,” Regulatory Focus

“The House Energy & Commerce Committee’s Health Subcommittee on Wednesday advanced five bills seeking to help increase generic drug competition. All five will now be considered by the full committee…”

“Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny — Again, The New York Times

“The Food and Drug Administration warned rogue stem-cell clinics on Wednesday to stop selling unproven treatments that could harm patients. The agency’s latest effort, like most of its previous ones, consisted only of letters to companies and clinics. One letter warned a company making products from umbilical-cord blood that it was violating federal law, and other letters told 20 clinics and stem-cell makers that they appeared to be subject to F.D.A. review for approval and that they should contact the agency about how to comply…”

“First gene therapy to treat rare blood disease nears European approval,” STAT

“The first gene therapy to treat a rare blood disorder is one step closer to approval Friday following a recommendation by European officials. Lentiglobin, the gene therapy for beta-thalassemia developed by Cambridge, Mass.-based Bluebird Bio, was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP), the drug-reviewing arm of the European Medicines Agency. A final approval decision is expected within the next three months…”

“AveXis to Acquire AstraZeneca Manufacturing Site in Longmont, CO,” Genetic Engineering News

“Novartis subsidiary AveXis plans to expand its gene therapy manufacturing capacity by agreeing to purchase AstraZeneca’s advanced biologics therapy manufacturing campus in Longmont, CO, for an undisclosed price…”

“Scientists Thought They Had Measles Cornered. They Were Wrong.,” The New York Times

“Following intensive vaccination efforts, measles cases plunged across the world. Now clusters of new infections — some linked, some not — have confounded health officials…”