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.

Cell Culture Events

March

Webinars:

“Development Strategies for High-performing Perfusion Media”

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.

“Designing the Most Cost-Effective Manufacturing Strategy for Allogeneic Cell-Based Therapies”

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.
• Align process development to the product roadmap.

Workshops:

Introduction to Protein Expression Workshop – 3 days by BioSciConcepts

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.

Conferences:

March

• Genome Editing Applications – March 18-19, 2015 – Hilton Boston Back Bay, Boston MA www.IBCLifeSciences.com/GenomeEditing
• 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

April

• World Vaccine Congress – April 7-9, 2015 –Walter E. Washington Convention Center– Washington D.C. http://www.terrapinn.com/conference/world-vaccine-congress-washington/index.stm
• Bioprocess International European Summit – April 14-15, 2015 – Swissotel Dusseldorf Neuss, Germany http://www.informa-ls.com/event/bpi15
• Interphex – April 21-23, 2015 – New York, NY – Javits Center – http://www.interphex.com/

May

• TIDES – May 3-6, 2015 – Town and Country Resort, San Diego, CA http://www.ibclifesciences.com/TIDES/overview.xml
• PEGS Boston – May 4-8, 2014 – Seaport World Trade Center – Boston, MA http://www.pegsummit.com/
• Cell Line Development & Engineering – May 18-20, 2015 – Parc 55 Wyndham San Francisco, CA http://www.ibclifesciences.com/CellLine/overview.xml Co-located with Bioconjugates: From Targets to Therapeutics – http://www.ibclifesciences.com/Bioconjugates/overview.xml and Next Generation Protein Therapeutics Summit – http://www.ibclifesciences.com/ProteinSummit/overview.xml
• 10^th Annual World Stem Cells and Regenerative Medicine Conference 2015 – May 20-22, 2015 – Business Design Centre, London, UK Scaling up, commercialization and collaboration for market access.
• Cord Blood World Europe Congress 2015 – May 20-21, 2015 – Business Design Centre, London, UK Build deposits, reduce costs, retain quality, decrease volume and increase utilization.
• ISCT – May 27-30, 2015 – Caesars Palace Hotel, Las Vegas, NV http://www.isct2014.com/
• Cell Culture World Congress USA – http://www.terrapinn.com/conference/cell-culture-world-congress-usa/index.stm Americas Antibody Congress http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52321.stm World Biosimilar Congress http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52322.stm Downstream Processing World http://www.terrapinn.com/conference/cell-culture-world-congress-usa/C52323.stm May 27-28, 2014 – Marriott San Diego Mission Valley – San Diego, CA

Headlines

“F.D.A. Approves Zarxio, Its First Biosimilar Drug,” The New York Times

“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”

“Bharat’s $1 rotavirus vaccine rolls out in India to challenge GSK, Merck,” Fierce Vaccines

“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”

“Top 10 U.S. Biopharma Clusters,” Genetic Engineering News

“This year’s Top 10 U.S. Biopharma Clusters List features the same 10 regions as last year’s GEN List, but the top seven occupy slightly different positions than they did in the 2014 list.”

If you like this story, please see our blog titled “The Benefits of Implementing Bioprocess Monitoring and Quality by Design in Process Development”

“FDA approves United Therapeutics’ drug for treating cancer in children,” Reuters

“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”

“Liberian Leader Concedes Errors in Response to Ebola,” The New York Times

“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”

“UC Berkeley researchers put their hearts into latest organ-on-a-chip project,” Fierce Biotech Research

“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?”

“CTI BioPharma blood cancer drug meets study goal,” Reuters

“CTI BioPharma Corp’s experimental blood cancer drug achieved the main goal of a late-stage study, but at least two analysts said the pill would not directly compete with Incyte Corp’s treatment.”

If you like this story, please see our blog titled “Intestinal Organoid Culture: a Convenient and Physiologically Relevant Model for Intestinal and Stem Cell Research”