This week’s biotechnology news headlines include, FDA approves its first biosimilar, $1 rotavirus vaccine in India, top 10 US Biopharma clusters, United Therapeutics’ cancer drug for children receives approval, errors in Ebola response, organ on a chip project, and blood cancer meets study goal.
Upcoming Ask the Expert Session
Using Intestinal Organoids for Intestinal and Stem Cell Research– Starts Monday!
Intestinal organoids provide a major advancement in the way we study intestinal and adult stem cell biology. When intestinal crypts containing LGR5+ intestinal stem cells (ISCs) are placed in a specialized medium that simulates the intestinal stem cell niche, the ISCs rapidly proliferate and differentiate into all of the major cell types found in the intestinal epithelium: Paneth cells, goblet cells, enteroendocrine cells, and enterocytes. Remarkably, these cells arrange themselves into a crypt-villus structure surrounding a functional central lumen, thus maintaining the stem cell pool while mimicking the physiology of the adult intestinal epithelium. The resulting organoids (or “mini-guts”) can be used for a variety of research applications.
As an in vitro system that is capable of providing in vivo insight, intestinal organoids signify an exciting new chapter for research. During this Ask the Expert session, Ryan Conder, Senior Scientist at STEMCELL Technologies, will be answering your questions about intestinal organoid culture, its research applications, and IntestiCult™ Organoid Growth Medium (Mouse), the first-ever complete, defined and serum-free medium for growing intestinal organoids from mouse intestinal crypts.
March 24, 2015
Biomanufacturers are increasingly driven to develop innovative solutions for highly efficient and cost-effective processes. Integrated continuous processing, comprising production in a high-cell density perfusion culture coupled to a continuous capture step, is a potential solution to serve as a universal biomanufacturing platform.
In this webcast, an expert describes a structured approach for developing a perfusion medium from a combination of commercially available medium and feeds. The medium optimization resulted in a final process with a cell-specific perfusion rate of about 20 pL/cell/d, a decrease of more than 75% compared with the starting process conditions.
Learn how this methodology can be applied to other cell culture media to serve as a fast route to an efficient upstream perfusion process. When combined with a continuous downstream operation, the resulting overall process can meet many demands of tomorrow’s biomanufacturing.
Key Learning Objectives:
Understand technologies that enable modern perfusion cell culture.
Review a fast and convenient strategy for developing a high-cell density perfusion process for Chinese hamster ovary (CHO) cells based on commercially available cell culture medium and feeds.
Learn how design of experiments (DoE) can be used in a structured approach to decrease the cell-specific perfusion rate in an existing process.
March 25, 2015
Learn the key bioprocess economic parameters to be considered when designing the manufacturing strategy for an adherent cell-based allogeneic product.
Developing the right industrialization strategy is critical to support a sustainable Cell Therapy development and commercialization program. Cell sources, stock management, and technology performance are some of the key parameters that determine the manufacturing scale required for specific product characteristics, supply chain, and business risk management.
Participants will learn:
Map the factors influencing your bioprocess scale.
Design optimized manufacturing strategies for allogeneic cell-based therapies.
Evaluate and select the most cost-effective technology according to the lot size.
April 8-10, 2015
This 3-day workshop will provide an overview of recombinant protein technology, recombinant protein system and vector choices, and prokaryotic expression. Additionally we will discuss the advantages of the eukaryotic expression, the baculovirus system, transformation and reading-frame considerations when expressing proteins in any system. Also included will be talks on strategies for cell harvesting, and protein purification.
Biopharmaceutical Development and Production Week – March 30-April 2, 2015 – Hyatt Regency Huntington Beach Resort and Spa, Huntington Beach, CA Co-located with Single-use Applications and Flexible Facilities http://www.ibclifesciences.com/BDPWeek/overview.xml
“The Food and Drug Administration has approved the first so-called biosimilar drug for use in the United States, paving the way for less expensive alternatives to an entire class of complex and costly drugs.”
If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”
“The biotech sector is poised to continue on its sharp growth trajectory, coming off of a year that saw some 34% of growth through 2014 and more than 300% growth over the last five years. Remedies for conditions like hepatitis C, NASH and oncology will all help drive growth in this sector, noted Asthika Goonewardene, senior biotechnology analyst for Bloomberg Intelligence.”
If you like this story, please see our blog titled “The Evolution of Vaccine Manufacturing – Past, Current, and Future Trends”
“The Food and Drug Administration said it approved United Therapeutics Corp’s drug to treat neuroblastoma, a rare cancer that typically occurs in children below 5 years.”
If you like this story, please see our blog titled “Materials and Assay Systems Used for 3D Cell Culture”
“The president of Liberia acknowledged on Wednesday that she had erred in ordering a tough security crackdown at the height of the Ebola crisis last year, describing the deadly virus as an “unknown enemy” that had frightened her.”
If you like this story, please see our blog titled “Developing Ebola Vaccine and Securing Your Cold Chain Logistics Plan”
“A group of bioengineers at UC Berkeley has been hard at work hatching a new “heart-on-a-chip” technology that aims to offer researchers a better, less expensive way to develop new drugs.”
If you like this story, please see our blog titled “Cell Therapy: Are we there yet?”