The Dish’s Weekly Biotechnology News Wrap Up – September 1, 2017

By on September 1, 2017

This week’s headlines include: F.D.A. Approves First Gene-Altering Leukemia Treatment, Costing $475,000, Samsung, Biogen version of AbbVie’s Humira approved in Europe, Gilead to Buy Kite, Maker of Cancer Treatments, for $11.9 Billion, MilliporeSigma to Acquire Natrix Separations, ‘Hit-and-run’ gene therapy nanoparticles could enhance CAR-T treatments, and Bayer, J&J in frame for bigger anti-clotting market opportunity.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

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Ensuring FBS traceability using chemical fingerprinting

Fetal bovine serum (FBS) quality and traceability are very important, particularly in applications where the product is being used in biomanufacturing. While there has been a trend in much of the biopharmaceutical industry to move away from animal-derived products, the vaccine industry still uses FBS in vaccine production…

All About Organoids

Held this year in Boston MA, the International Society for Stem Cell Research (ISSCR) Conference 2017 brought together more than 4,000 researchers, bioethicists, clinicians, and industry professionals from all over the globe to discuss the latest discoveries and technologies in stem cell research and their contributions to advancing regenerative medicine. This year, the plenary session topics included an exciting and rapidly expanding area of research—organoids. An organoid, in the most basic sense, is a miniaturized and simplified version of an organ produced in vitro in three dimensions that show realistic micro-anatomy. Unlike two dimensional (2D) cell cultures, organoids enable three-dimensional (3D) cell growth, movement and differentiation, making this technology an effective model for understanding organ development, tissue morphogenesis and the genetic or molecular basis of diseases (Xinaris et al, 2015)…

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…


The Down Stream Column

Automated, single-use filtration to increase efficiency in upstream and downstream operations

In examining ways to improve overall bioprocess efficiency, filtration is a step that can sometimes be overlooked. However it is a key area to improve efficiency, as it is part of both upstream and downstream operations and consumes sizeable resources. The application of single-use technologies coupled with increased automation have successfully improved efficiency in other bioprocess operations, thus it is logical that filtration would also benefit from these technologies…

Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutions

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…

Events:

September

Bioprocess International Conference (BPI East)

September 25-28, 2017
Hynes Convention Center,
Boston, MA

The 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

World Vaccine Congress

October 10October 12
CROWNE PLAZA BARCELONA, BARCELONA, Spain

Make sure you are at the forefront of the vaccines industry. No matter where your interest lies, at the 18th annual World Vaccine Congress we have content, networking and potential partners for you.

Speed to IND for Biologics

October 19October 20
Hyatt Centric Fisherman’s Wharf, 555 North Point Street
San Francisco, 94133 United States

With 32 expert presenters, 20 case studies/new data presentations and just two days out of the office, you won’t want to miss this first-of-its-kind event!

November

3rd Annual Cell & Gene Therapy Congress

November 6November 7
immarsat, 99 City Road
London, EC1Y 1AX United Kingdom

Oxford Global Conferences presents its 3rd Annual Cell & Gene Therapy Congress, with our co-located 6th Annual Cell Culture & Bioprocessing Congress and 4th Annual Stem Cell Congress and, 6 – 7 of November 2017, London, UK. View Agenda: bit.ly/2b80uCZ 4 interactive streams: Cell & Gene Therapy: Development & Clinical Trials Cell Therapy Bioprocessing and Manufacturing Presentations will include cell & gene therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing.

World Orphan Drug Congress Europe

November 13November 15
FAIRMONT REY JUAN CARLOS I, Av. Diagonal, 661-671
BARCELONA, 08028 Spain

The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access.

Headlines:

“F.D.A. Approves First Gene-Altering Leukemia Treatment, Costing $475,000,” The New York Times

“The Food and Drug Administration on Wednesday approved the first-ever treatment that genetically alters a patient’s own cells to fight cancer, a milestone that is expected to transform treatment in the coming years. The new therapy turns a patient’s cells into a “living drug,” and trains them to recognize and attack the disease. It is part of the rapidly growing field of immunotherapy that bolsters the immune system through drugs and other therapies and has, in some cases, led to long remissions and possibly even cures…”

“Samsung, Biogen version of AbbVie’s Humira approved in Europe,” Reuters

“A biosimilar version of AbbVie Inc’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc and Samsung Biologics, was approved by European Union regulators, the partners said on Thursday. The new drug, Imraldi, marks the third European Commission approval for “biosimilar” versions from the joint venture, Samsung Bioepis, of drugs in a class known as TNF inhibitors…”

“Gilead to Buy Kite, Maker of Cancer Treatments, for $11.9 Billion,” The New York Times

“The drugmaker Gilead Sciences said on Monday that it would buy Kite Pharma for about $11.9 billion to bolster its aging portfolio with an emerging cancer treatment. The acquisition, Gilead’s first major deal since 2011, is a departure from the path followed by the broader pharmaceutical industry, where — apart from Johnson & Johnson’s $30 billion takeover of the Swiss biotechnology company Actelion — the pace of acquisitions had largely slowed this year. Many drugmakers that had been busy with takeover activity in recent years have since been at work integrating their purchases…”

“MilliporeSigma to Acquire Natrix Separations,” Genetic Engineering News

“MilliporeSigma said today it plans to acquire Natrix Separations for an undisclosed sum, a purchase designed to accelerate the buyer’s monoclonal antibody (mAb) and vaccine manufacturing offerings and complement its next-generation bioprocessing efforts through expansion of its single-use chromatography portfolio…”

“‘Hit-and-run’ gene therapy nanoparticles could enhance CAR-T treatments,” FierceBiotech

“Personalized cancer treatments known as CAR-T cells (chimeric antigen receptor T cells) have dominated the headlines lately, thanks to Novartis’ tisagenlecleucel, which won an early approval from the FDA for the treatment of leukemia on Aug. 30. But CAR-T treatments are labor-intensive and expensive to make, and they can attack healthy tissues in the body, leading to dangerous side effects…”

“Bayer, J&J in frame for bigger anti-clotting market opportunity,” Reuters

“Bayer and Johnson & Johnson’s blockbuster clot prevention drug Xarelto was shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 percent, raising the prospects of billions more in sales…”

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