The Dish’s Weekly Biotechnology News Wrap Up – August 18, 2017
This week’s headlines include: Scientists report progress on “liquid biopsies” for cancer screening, FDA approves Pfizer’s drug for rare blood cancer, Takeda R&D reboot continues with Stanford drug discovery deal, MilliporeSigma to Be Granted European Patent for CRISPR Technology, and Amgen falls short in Epogen patent appeal but Pfizer stumble delays competition.
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…
Continuous bioprocessing – moving from theory to reality
Over the last decade, advances in the upstream processing of monoclonal antibodies (mAbs) has resulted in higher bioreactor titers. With increasing titers, the production bottleneck has shifted to downstream processing. Hence, the biopharmaceutical industry has reached a milestone where the need for higher throughput in downstream processing is leading to the adoption of more efficient multi-column continuous (MCC) counter-current chromatography systems which increase overall productivity while significantly reducing consumables costs…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…
Events:
August
September
Bioprocess International Conference (BPI East) September 25-28, 2017 Hynes Convention Center, Boston, MAThe largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success. BPI provides the solutions needed to move drug candidates closer to approval.
October
November
3rd Annual Cell & Gene Therapy Congress
World Orphan Drug Congress Europe
Headlines:
“Scientists report progress on “liquid biopsies” for cancer screening,” CBS News
“Scientists have the first major evidence that blood tests called liquid biopsies hold promise for screening people for cancer. Hong Kong doctors tried it for a type of head and neck cancer, and boosted early detection and one measure of survival. The tests detect DNA that tumors shed into the blood. Some are used now to monitor cancer patients, and many companies are trying to develop versions of these for screening, as possible alternatives to mammograms, colonoscopies and other such tests. The new study shows this approach can work, at least for this one form of cancer and in a country where it’s common…”“FDA approves Pfizer’s drug for rare blood cancer,” Reuters
“The U.S. Food and Drug Administration (FDA) said on Thursday it approved Pfizer Inc’s rare blood cancer drug, Besponsa, with a boxed warning. A boxed warning is the agency’s severest form of warning reserved to caution against the most serious side effects. Besponsa was approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a disease that will affect about 5,970 people in the United States this year and kill about 1,440, according to the National Cancer Institute…”