The Dish’s Weekly Biotechnology News Wrap Up – August 4, 2017
This week’s headlines include: What Does Your Microbiome Say About You?, AstraZeneca gets breakthrough status for blood cancer drug, Could CAR-T treatments work in glioblastoma?, In Breakthrough, Scientists Edit a Dangerous Mutation From Genes in Human Embryos, Mosquito Season Is Spreading Zika and West Nile Across the U.S., Amgen gets fast FDA review for adding heart benefits to cholesterol drug label, and Invenra Signs On With Merck in Antibody Discovery Partnership.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Continuous suspension cell culture monitoring in bioreactors using quantitative phase imaging
Cell culture monitoring for cell count and cell viability typically involves manual sampling from each bioreactor followed by Trypan-blue cell exclusion. This sampling needs to happen at least once per day and ideally more often. An operator must then enter the results into a spreadsheet or other tracking software and generate a growth curve. The challenge with this process is that it is highly manual, and time consuming. Sampling an entire facility means a whole team is required to monitor what can be upwards of 50+ bioreactors. In addition, manual sampling creates an opportunity for contamination and variability…
Automated Optimization of IgG Production in CHO Cells
An ideal approach to media optimization is using a factorial design of experiment (DOE), where a variety of media components are tested at different concentrations in combination with one another. However, these factorial experiments rapidly increase the number of conditions that require testing. Common ways of quantifying the production of IgG or other proteins are frequently labor intensive (i.e. ELISAs) or prohibitively slow (i.e. HPLC), particularly at the high throughputs required for DOE…
First In-Human Allogeneic Clinical Trial Commences with iPSC-derived Mesenchymal Stem Cells
It is widely accepted that stem cells can be divided broadly into embryonic and non-embryonic stem cells. Embryonic stem cells (ESCs) are derived from the inner cell mass of blastocysts and are pluripotent, meaning they can differentiate into cells of all three germ layers: ectoderm (outer layer), mesoderm (middle layer), and endoderm (inner layer). Conversely, non-embryonic stem cells are found in the extra-embryonic tissues (placenta, umbilical cord blood and amniotic fluid) and in all adult tissues, (i.e. bone marrow, fat, kidney, etc). Human mesenchymal stem cells (hMSCs) are an example of non-embryonic stem cells and were first isolated in the bone marrow and characterized by Friedenstein and his colleagues in 1974 (Amorin, 2014). hMSCs, also called mesenchymal stromal cells, are a subset of non-hematopoietic adult stem cells that originate from the mesoderm (Kim et al, 2013). They are considered to be multipotent; able to self-renew and generate progeny of several distinct cell types…
In-line Viral Load Measurement using Smart Cell Culture Monitoring
Smart in-line cell culture monitoring as an efficient way to measure viral load in real-time. This kind of real-time measurement is only possible with the iLine F. The iLineF is an innovative microscopy technology that instead of taking a 2D image of a microscopic object, takes a hologram of a microscopic volume. Then for each microscopic object within the culture volume, it can compute a holographic fingerprint. This fingerprint can then be used to analyze, identify, count and assess viability of cells in culture…
Impact of Continuous Chromatography Mode on Protein A Resin Lifetime
Traditionally, Protein A chromatography is performed in batch mode using a single, packed column. In batch operations, antibody-containing samples are loaded onto the column at levels well below the total capacity of the resin to prevent sample breakthrough and subsequent product loss. However in recent years, continuous chromatography has emerged as an alternative to batch operations to improve productivity or increase resin capacity utilization of chromatography purification processes. Continuous chromatography by periodic counter-current chromatography (PCC) has been demonstrated to increase utilization of the chromatography resin capacity…
Fine Tuning Viral Clearance Approaches with a Total Viral Challenge Strategy
In this mini-webinar, Michael Burnham, M.S., Senior Principal Scientist, Process Development and Commercialization, WuXi AppTec, presents a viral clearance strategy that focuses on spiking load or starting material based on total viral load instead of percent spike model…
Continuous bioprocessing – moving from theory to reality
Continuous manufacturing has been established in several processing industries for many years, providing many benefits over batch manufacturing. The feasibility of continuous processing has now been shown for monoclonal antibodies (mAb) at both the process development (PD) and the production scales by early adopters…
Subvisible Particle Characterization: Why Simply Counting Shadows Leaves You in the Dark
Significant advances in analytical technology over the past few years have improved the quantification and characterization capabilities for subvisible ( 1 – 100 µm) and submicron particles (≤1 µm). As the technology continues to improve so do the expectations of regulatory agencies for sponsors to characterize particles in these size ranges. However, multiple orthogonal methods are required to span the entire range and accurately characterize the particle profile. Each instrument has its own limitations based on detection method and properties of therapeutic protein products that must be well understood to generate high quality data. KBI Biopharma has extensive experience with particle detection methods, as well as, in-depth particle data analysis. KBI’s Particle Characterization Core team can help choose appropriate orthogonal particle to combine in order to accurately quantify, characterize and identify particles in specific therapeutic protein products for all size ranges based on clients’ needs
Headlines:
“What Does Your Microbiome Say About You?,” The New York Times
“There are trillions of microbial species in the world and thousands of them live in or on the human body. Bacteria, fungi, viruses and other microorganisms congregate in mini ecosystems called microbiomes, found almost anywhere you can imagine…”
“AstraZeneca gets breakthrough status for blood cancer drug,” Reuters
“AstraZeneca said on Tuesday that U.S. regulators had awarded its blood cancer drug acalabrutinib “breakthrough” status for the treatment of patients with mantle cell lymphoma, a rare type of blood cancer…”
“Could CAR-T treatments work in glioblastoma?,” FierceBiotech
“The news last week that Arizona Senator John McCain has been diagnosed with glioblastoma brought stark reminders of the challenges presented by this particular type of brain tumor: The five-year survival rate for glioblastoma patients over age 55 is just 4%, according to the American Cancer Society. Now researchers at the University of Pennsylvania have generated evidence that combining different types of immuno-oncology treatments be key for engaging the immune system to fight glioblastoma—data they outlined one day before McCain’s diagnosis was revealed…”
“In Breakthrough, Scientists Edit a Dangerous Mutation From Genes in Human Embryos,” The New York Times
“Scientists for the first time have successfully edited genes in human embryos to repair a common and serious disease-causing mutation, producing apparently healthy embryos, according to a study published on Wednesday…”
“Mosquito Season Is Spreading Zika and West Nile Across the U.S.,” Newsweek
“When U.S. temperatures rise in the summertime, most states anticipate growth in the mosquito population, and a corresponding increase in transmission of blood-borne viruses that can cause serious illnesses…”
“Amgen gets fast FDA review for adding heart benefits to cholesterol drug label,” Reuters
“Amgen Inc said on Thursday the U.S. Food and Drug Administration granted priority review to the company’s request to add important heart safety data to the label of its expensive injectable cholesterol drug Repatha…”
“Invenra Signs On With Merck in Antibody Discovery Partnership,” Xconomy
“Invenra has had success developing therapeutic antibodies for its own drug research, and for the research of others. Now the Madison, WI-based company has signed on with pharma giant Merck, which hopes Invenra’s antibody expertise can help it develop new drugs…”