The Dish’s Weekly Biotechnology News Wrap Up – August 25, 2017
This week’s headlines include: Novartis Speeds New Anti-Malarial as Older Drug Loses Potency, Zika has all but disappeared in the Americas. Why?, Cellectis Starts BPDCN Phase I Trial with Gene-Edited CAR-T Therapy, FDA Offers Draft Guidance to Further Secure Drug Supply Chain, Novartis CEO opens door to cancer patient demanding ‘fair’ CAR-T pricing, and U.S. DOD to Start New Trial with Pluristem’s PLX-R18 Cell Therapy Against ARS.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Efficient Large-Scale Expansion of MSCs for Translational Medicine and Research Use
As part of our ongoing conference coverage of ISSCR 2017, we like to feature posters from the event. One poster covered the very important topic of large-scale expansion of mesenchymal stem cells (MSCs) for both research and translational medicine. The poster, “Expansion of MSCs for Translational Medicine using MSC NutriStem® Basal Medium and PLTMax® Human Platelet Lysate,” was jointly presented by Biological Industries USA and Mill Creek Life Sciences, and highlighted at the Biological Industries booth. In the poster, authors describe the importance of successful large-scale expansion of MSCs and present data on a culture protocol that has generated very successful results…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…
Bioburden contamination in biopharmaceutical manufacturing is a big concern. Contamination carries both tremendous cost and preventing it requires strict control of several possible entry points. The cost of bioburden contamination for a company can involve lost time, lost material, batch loss, possible facility closure and extensive QA/QC time to ensure proper cleaning and validation. In the worst case scenario, it can prevent supply of much needed medicine to patients and loss of commercial revenue…
Cool Tool – Achieve Integrated and Scalable Continuous Chromatography 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…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…Events:
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