This week’s biotechnology news headlines include, stem cell heart treatment gets fast track in Europe, pacific trade agreement addresses biologics exclusivity, FDA approves BMS’ Yervoy and Opdivo for melanoma, Avelumab fast-tracked, Seattle biotech and MD Anderson launch immunotherapy company, and Amicus delays filing for U.S. marketing rights on Fabry disease drug.

Cell Culture Events

Conferences:

October

• Bioproduction – October 14-15, 2015 – Dublin, Ireland – http://www.informa-ls.com/event/bio-production14Benchmark technological developments and explore best practices in biomanufacturingThe biopharmaceutical industry is making a capital investment of approximately $8 billion in new facilities in Ireland, most of which has come in the last 10 years, representing close to the biggest wave of investment in new biotech facilities anywhere in the world.Join us at BioProduction 2015 in Dublin this October to see why so much is being invested in this area and to network with leading players within this growing industry!BioProduction 2015: Europe’s leading and largest event for a comprehensive update on all aspects of large scale biological manufacturing. Providing insights on the latest technologies, upstream/downstream processing, process analytics, the implementation of continuous manufacturing, facility design, flexibility facilities and single use systems to reduce inefficiencies during the biomanufacturing process.4 Conferences – 1 Exhibition – 1 Congress
  • Conference 1: Continuous Manufacturing
  • Conference 2: Upstream Processing – Production, Development & Analytics
  • Conference 3: Manufacturing Strategy & Technology
  • Conference 4: Downstream Processing

  For more information on the 2015 event please visit the event website at http://www.informa-ls.com/CQ3531BioproductionCellEL

• Bioprocessing International – October 26-29, 2015 Hynes Convention Center Boston, MA http://www.ibclifesciences.com/BPI/overview.xml

If you are attending BPI, don’t miss these keynotes on October 28^th:

Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd. – Amgen’s Next-Generation Biomanufacturing Facility

Ms. Hall’s presentation will outline a “Next-Generation Biomanufacturing” platform for fast and flexible drug operations for synthesis of drug substance in a reconfigurable manufacturing system. She will discuss key enabling technologies, including modular construction, single-use bioreactors, disposable plastic containers, continuous purification processing, and real-time quality analysis.

Konstantin Kostantinov, Ph.D., Vice President, Technology Development, Genzyme – What is the Future of Continuous Processing – What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?

The transition from batch to continuous processing as a reflection of the maturation of the biotechnology industry will be presented in this keynote by Dr. Kostantinov, who will also explain how continuous processing offers biotechnology companies increased flexibility. The keynote will focus on how more flexible management of manufacturing capacity according to market demand is possible, as is improved quality control. While continuous processing was previously limited to upstream due to a lack of unit operations available for downstream, several companies have now entered the market, paving the way for a movement toward integrated up- and downstream continuous processing.

November

• Bioproduction Summit 2015 – November 2-3, 2015 – Hilton San Francisco Airport Bayfront – Burlingame, CA Bioproduction Summit 2015 will focus on quintessential topics in Biotech field, such as technology advances in protein production, Cell culture, Bioprocess Development and Novel protein therapeutics. http://www.bioproductionsummit.com
• World Vaccine Congress – November 3-5, 2015 – Sheraton Brussels Airport Hotel – Brussels, Belgium –  For 15 years the World Vaccine Congress in Europe has been the leading event to talk about scientific advances and find new business opportunities within the vaccine sector and this year is no exception. http://www.terrapinn.com/conference/world-vaccine-congress-europe/index.stm
• FAST: Functional Analysis & Screening Technologies Congress – November 9-11, 2015 – Renaissance Waterfront Hotel – Boston, MA -Cambridge Healthtech Institute (CHI) is pleased to announce the Third Annual FAST: Functional Analysis and Screening Technologies Congress. Now in its third year, the FAST Congress brings you the latest technologies and research in cellular screening. – http://www.fastcongress.com/

Headlines

“Welsh stem cell firm wins fast-track filing path in Europe,” Reuters

“A biotech company founded by a Nobel prize winner has won the go-ahead from European regulators to begin the application process for conditional marketing authorization of a stem cell-based regenerative heart treatment.”

If you like this story, please see our blog titled “Quality by Design – Maintaining Strict Control of Bioprocess Conditions”

“Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity,” Regulatory Focus

“Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity.”

If you like this story, please see our blog titled “Protein A – Evolution and Optimization Strategies”

“FDA Approves Bristol-Myers’s Yervoy, Opdivo for Treatment of Melanoma,” The Wall Street Journal

“The U.S. Food and Drug Administration approved the first therapy combining two cutting-edge cancer drugs that unleash the body’s immune system against tumors—a combination that will cost more than $250,000 per patient for the first full year, according to its manufacturer.”

If you like this story, please see our blog titled “Cool Tool – STEP Technology for the rapid generation of very high producing stable CHO cell lines”

“Merck/Pfizer’s avelumab fast-tracked for rare skin cancer,” Pharma Times

“Merck and Pfizer’s investigational immunotherapy avelumab has been granted Fast Track designation in the US in a move designed to accelerate its development for a rare and aggressive skin cancer called metastatic Merkel cell carcinoma.”

If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”

“Seattle biotech teams up with MD Anderson, launches new immunotherapy company,” Puget Sound Business Journal

“A Seattle biotech firm has joined forces with a Texas research center to accelerate discoveries of therapies to treat cancer.”

If you like this story, please see our blog titled “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”

“Amicus to delay filing for U.S. marketing rights for lead drug,” Reuters

“Amicus Therapeutics Inc said it was unlikely to submit a U.S. marketing application for its lead drug, to treat Fabry disease, by the end of 2015 as expected, after U.S. health regulators asked for a more comprehensive analysis of trial data.”

If you like this story, please see our blog titled “You can teach an old dog new tricks: Vero cells for virus-based cancer vaccine therapies”

“Pacific-Rim Nations Led by U.S. Agree to Historic Trade Deal,” Bloomberg Business

“A dozen Pacific-rim nations agreed to an historic pact that would cut trade barriers on items ranging from cars to rice, setting up a potentially contentious ratification vote before a skeptical U.S. Congress.”

If you like this story, please see our blog titled “Exosomes: A Major Phenomenon Flying Under the Radar”