This week’s headlines include: Novo Nordisk, Red Cross team up to tackle chronic diseases in conflict zones, Sanofi to Build $431M Vaccine Plant in Toronto, GE rides Gene Therapy wave with ready-made viral drug factories, Bristol Partners With Illumina On Diagnostic Test To Use With Opdivo, and ‘Cell-free’ CRISPR could improve cancer diagnostics, unravel how gene editing works.

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

Optimizing Virus Production Media for Cell-based Vaccine manufacturing

There has been increasing interest in moving from egg-based vaccine manufacturing to cell culture-based methods. Cell-based vaccine manufacturing is quicker, efficiently scalable and offers more control over the manufacturing environment. There is also the advantage of fewer virus mutations and thus a more effective vaccine. This was certainly true with the 2017-2018 flu season. In a recent PBS article, “Flu vaccine grown without eggs provided measurably better protection this season, FDA says,” the FDA reported that the approved cell-culture based influenza vaccine performed about 20 percent better than the standard egg-based vaccines. This is due to the fact that the viruses have to adapt to grow in the eggs and with this adaptation can come mutations that render the vaccine less effective…

Insights and Innovations From the 2018 World Vaccine Congress

For the past 18 years, the World Vaccine Congress has played a prominent role in educating biotech industry leaders on the latest research, innovations, and advocacy in vaccine development. This year’s World Vaccine Congress took place April 2 – 5 in Washington D.C., with 1000+ attendees, 250+ speakers, and 60+ exhibitors. According to a conference organizer, this year’s congress was both the largest and most successful event to date, with a ~25% increase in overall attendance…

Bioprocessing Technologies for Stem Cell Therapy Manufacturing

In this podcast and accompanying article, we interviewed Ricardo Baptista, Lead Process Development Scientist, Cell and Gene Therapy Catapult, UK about his impressions on current bioprocessing technologies for stem Cell Therapy manufacturing and possible future innovations…

Significant Growth Expected for Stem Cell Manufacturing Market

The market outlook has proven favorable for regenerative medicines as well as genetically modified Cell Therapy products. The role of stem cells has grown vastly; various stem cell lines are being evaluated by life science researchers for use in effective disease management and biological studies. This trend has provided a lucrative growth opportunity for cell line manufacturers offering specific stem cell lines and related products…

Intensify process development steps and simplify transfer to GMP environment with new ÄKTA pilot 600 chromatography system

The bioprocess industry is leaving the blockbuster era. The strive to shorten time to market is constant, which puts pressure on the entire drug development process from research to manufacturing. With more drugs in pipeline, biomanufacturers need flexibility, efficient changeovers, and accelerated scale-up and transfer to the next development phase…

Cell Harvesting – Selecting a technology compatible with cell density and feed turbidity

In this podcast and accompanying article, we interviewed Silke Bergheim-Pietza, Global Product Manager Depth Filtration, Pall. We discussed challenges faced in the cell harvesting step, in particular, selecting the best cell harvesting method based on the cell density and feed turbidity of the process and meeting the demand of increasing cell densities. Download the cell harvesting technology selection guide and use the guide to compare the latest single-use harvesting technologies...

Flexible Downstream Platform Facilitates Adaptation to Scale

In biomanufacturing, upstream titers are increasing as new cell lines and technologies are being developed. This puts pressure on downstream processes, especially the capture step…

Integrating Downstream Unit Operations – Polishing and Concentration Steps

Most downstream biomanufacturing process steps are conducted as separate unit operations. As such, there are a great number of manual tasks including individual instrument function, intermediate handling of material, and product transfer. This high reliance on manual tasks consumes more resources and introduces greater opportunity for operator error…

Webinar:

Ensure Integrity of Your Single-Use Systems

Date & Time: Thursday, April 26, 2018:  8:00 AM BST / 9:00 AM CEST / 12:30 PM IST / 3:00 PM SGT / 4:00 PM JST

Date & Time: Thursday, May 3, 2018:  8:00 AM PDT / 10:00 AM CDT / 11:00 AM EDT

In this 45-minute webinar, experts from Pall Biotech will discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substances and drug products processes. They will take into account the life cycle of the SUS; from its manufacturing to end user’s deployment and use.

You will learn about:

• The industry trends and recommended approach for the assurance of integrity of single-use systems
• Available solutions for the highest level of assurance of integrity of SUS
• A new integrity test for Allegro 2D biocontainer assemblies

To learn more, click Register

Conferences:

Stem Cell Community Day

The second international Stem Cell Community Day will take place on April 24, 2018 in Duesseldorf, Germany. The event brings together experts from industry and academia to discuss recent trends, achievements, and challenges in bioprocessing technologies for Stem Cell Research. The conference is organized by leading life science company Eppendorf AG. In three sessions, the participants will discuss ways for establishing robust stem cell culture protocols, process strategies for obtaining commercial cell quantities, and challenges related to product purity. Professor Joaquim M. S. Cabral from the University of Lisbon will chair the conference. Dr. Robert Zweigerdt from Hannover Medical School and Karen Coopman, PhD from Loughborough University will present their latest findings in keynote lectures. For more information, please see www.stemcellday.de

Podcasts:

Check out our podcast channel. We have over 20 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

Headlines:

“Novo Nordisk, Red Cross team up to tackle chronic diseases in conflict zones,” Reuters

“Danish drugmaker Novo Nordisk and aid agency Red Cross have teamed up to try to improve the treatment of chronic diseases among the millions affected by conflicts and humanitarian crises in countries such as Syria and Yemen…”

“Sanofi plans to double its vaccine output by 2023 by building a €350 million ($431.5 million) vaccine manufacturing plant in Toronto. The project underscores the company’s reliance on vaccines as an engine for future growth despite more than $300 million in fourth-quarter charges tied to setbacks with two vaccines…”

“GE rides Gene Therapy wave with ready-made viral drug factories,” Reuters

“General Electric is raising its bet on biotechnology with the launch of prefabricated manufacturing units for producing virus-based gene and cell therapies, novel anti-cancer treatments and vaccines…”

“Bristol Partners With Illumina On Diagnostic Test To Use With Opdivo,” Forbes

“Drug giant Bristol-Myers Squibb is partnering with Illumina, the leading maker of DNA sequencing gear, to develop diagnostic tests that will pair with Bristol’s cancer drugs. One of the first tests will be for tumor mutation burden, a measure of how much a tumor’s DNA has changed compared to the patient’s healthy cells. Cancer drugs that target the immune system, like Bristol’s Opdivo (2017 sales: $4.9 billion) and Yervoy (2017 sales: $1.2 billion), may work better in patients where the tumor mutation burden is higher, because this may make the cancer easier for the immune system to “see…”

“‘Cell-free’ CRISPR could improve cancer diagnostics, unravel how gene editing works,” FierceBiotech

“Researchers have been developing CRISPR gene editing as a potential therapeutic tool for years, but its most immediate use may be a less obvious one: cancer diagnostics. In what they say is a first for the gene-editing technology, researchers from Christiana Care Health System used CRISPR to edit DNA outside the cell, laying the groundwork for a diagnostic test that can replicate DNA mutations in a patient’s tumor and help physicians identify the most appropriate treatment…”