The Dish’s Weekly Biotechnology Wrap Up – July 28, 2017
This week’s headlines include: In US First, Scientists Edit Genes of Human Embryos, GlaxoSmithKline’s new boss streamlines R&D, axes slew of drugs, CIRM Approves $5.8 Million Grant for CAR-T Therapy that Targets Cancer Stem Cells, Lyme Disease Vaccine on Fast Track for FDA Approval, Corning, with assists from Pfizer and Merck, plans $500M pharma glass project that Trump announced, BrainStorm Wins $15.9M CIRM Grant for Phase III Trial of ALS Cell Therapy, and HIV fight advances with new drug cocktails, fresh vaccine hopes.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
Characterization and analysis of subvisible particles of biological origin can be challenging or give insufficient information. In this study Adeno associated virus (AAV) particles contaminated by host cell proteasomes are analysed with direct versus indirect methods performed in a standard laboratory setting to reveal the difference in performance and quality of the information obtained. The focus is on the ability to detect the AAV particles of interest and distinguish them from the contaminating proteasomes…
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:
“In US First, Scientists Edit Genes of Human Embryos,” The New York Times
“For the first time in the United States, scientists have edited the genes of human embryos, a controversial step toward someday helping babies avoid inherited diseases…”
“GlaxoSmithKline’s new boss streamlines R&D, axes slew of drugs,” Reuters
“GlaxoSmithKline’s new chief executive announced plans on Wednesday to narrow the focus of the group’s drug research by ditching more than 30 drug projects to improve returns in its core pharmaceuticals business…”
“CIRM Approves $5.8 Million Grant for CAR-T Therapy that Targets Cancer Stem Cells,” UC San Diego Health
”The Independent Citizens Oversight Committee of the California Institute for Regenerative Medicine (CIRM) today unanimously approved a $5.8 million award to University of California San Diego School of Medicine researchers to develop a new immunotherapy in which patients’ cells would be equipped with a special receptor that recognizes and targets cancer stem cells, whose survival abilities often render standard therapies ineffective or short-term…”
“Lyme Disease Vaccine on Fast Track for FDA Approval,” Newsweek
“The U.S. Food and Drug Administration (FDA) this week announced plans to expedite approval of a vaccine for Lyme disease. Valneva, the maker of the vaccine candidate, known as VLA15, recently completed an initial evaluation in a small, early stage clinical trial. Now the company has been given a green light by the regulatory agency through a program known as Fast Track to move onto a larger trial at the beginning of 2018. Additionally it will announce findings from the first trial around the same time. The designation could reduce the amount of time required for developing the vaccine by several years. With crucial agents that are fast-tracked, the FDA will accept less data and studies can be completed after approval…”
“Corning, with assists from Pfizer and Merck, plans $500M pharma glass project that Trump announced,” FiercePharma
“U.S. manufacturer Corning said it is time the pharmaceutical industry has new, more durable glass for its new injected medicines, and with input and commitments from Pfizer and Merck & Co., it intends to produce it in the U.S…”
“BrainStorm Wins $15.9M CIRM Grant for Phase III Trial of ALS Cell Therapy,” Genetic Engineering News
“BrainStorm Cell Therapeutics has won a $15.9 million grant from California’s regenerative medicine agency toward a Phase III trial of its amyotrophic lateral sclerosis (ALS) Cell Therapy candidate NurOwn®…”
“HIV fight advances with new drug cocktails, fresh vaccine hopes,” Reuters
“Three decades after approval of the first-ever AIDS treatment, HIV medicine is seeing a new wave of innovation with scientists reporting positive data on Monday for improved drug cocktails and a novel experimental vaccine…”