The Dish’s Weekly Biotechnology News Wrap Up – August 11, 2017

This week’s headlines include: Heart and Asthma Monitors? There’s an App for That, Kite Pharma Submits IND for BCMA-Targeting CAR-T Cancer Immunotherapy, FDA Finalizes 46 Bioequivalence Guidances, Rare leukemia targeted by modifying patients’ immune cells, Senate passes bill to improve cancer drugs for children, and Cellular ‘garbage disposal’ units fingered in Alzheimer’s development.

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…


The Down Stream Column

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


“Heart and Asthma Monitors? There’s an App for That,” The New York Times

“He could have been surfing in Cabo. Instead, Tyler Crouch, then a 21-year-old mechanical-engineering student, spent spring break of 2013 building a digitized stethoscope and thinking, “This better be worth it.”

“Kite Pharma Submits IND for BCMA-Targeting CAR-T Cancer Immunotherapy,” Genetic Engineering News

“KITE-585 is Kite’s third CAR-T cancer immunotherapy candidate to advance into the clinic and beyond. The company in March completed its Biologics License Application seeking FDA approval for its lead CAR-T product axicabtagene ciloleucel (formerly KTE-C19) in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT)…”

“FDA Finalizes 46 Bioequivalence Guidances,” Regulatory Focus

“In its continued push to support the development of generic drugs, the US Food and Drug Administration (FDA) on Friday finalized 46 product-specific bioequivalence guidances…”

“Rare leukemia targeted by modifying patients’ immune cells,” New Haven Register

“Young patients with a particular type of leukemia who have relapsed after going into remission may find new hope through a treatment that involves modifying a patient’s own T cells, an important part of the immune system, to destroy cancer cells…”

“Senate passes bill to improve cancer drugs for children,” USA Today

“Until now, drug companies have been free to decide whether to pursue treatments for pediatric cancers as part of their work on adult cancers. They won’t have much choice going forward. The Senate on Thursday overwhelmingly passed legislation requiring the pharmaceutical industry to expend more resources on treatment for childhood cancers. The bill, part of a larger measure reauthorizing user fees imposed by the Food and Drug Administration, heads to President Trump for his expected signature…”

“Cellular ‘garbage disposal’ units fingered in Alzheimer’s development,” Fierce Biotech Research

“Lysosomes play an important role in cells: They break down old material so the body can dispose of it. Now, scientists at Yale University are zeroing in on lysosomes in the brain, and they believe they’ve discovered how these “garbage disposal” units may contribute to the buildup of the amyloid plaques characteristic of Alzheimer’s disease…”

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