This week’s biotechnology news headlines include, millions need H.I.V. treatment according to WHO, Roche’s skin cancer drug gets EU backing, Avastin biosimilar hits Ph. III targets, Cell Therapy company launches crowd funding campaign, MedImmune and 3M work on next generation cancer drug, Novartis launches portfolio for low and middle income countries, and FDA approves NovoNordisk diabetes drug.

Cell Culture Events Webinars:                     Single-use equipment extractables testing: a look forward

Tuesday, October 6, 2015  |  10:00 AM / 1:00 PM / 4:00 PM EST

Learn about the industry’s progress towards creating a standard for the design and execution of extractables studies for single-use equipment. The webinar attempts to place the discussion into a wider context. Assuming the industry adopts such a standard, what problems would this solve and what are the next questions the industry should consider for collaborative discussions and resolution?

More information can be found on this registration page here: https://cc.readytalk.com/cc/s/registrations/new?cid=pyhfva4hnjw7

Conferences:

September

• Cell Therapy Bioprocessing – September 30 – October 2, 2015 – The Hilton Alexandria Mark Center, Alexandria, VA http://www.ibclifesciences.com/CellTherapy/overview.xml

Roche Custom Biotech will be exhibiting at the Cell Therapy Bioprocessing Annual meeting in Alexandria, VA, September 30-October 2. Visit us in booth #8 to learn more about our range of solutions for Cell Therapy applications, including Liberase enzyme blends for dissociating cells from primary tissues, bio-analytical instrumentation, downstream proteases, and quality control testing kits. To learn more see Roche Custom Biotech Conference Activities

If you are attending Cell Therapy Bioprocessing, please use the #IBC_CTB15 hash tag to post information and to follow conference activites.

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

Don’t miss this interesting talk at BPI this year:

Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the ‘process of the future’ will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.

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

“Millions More Need H.I.V. Treatment, W.H.O. Says,” The New York Times

“The World Health Organization issued sweeping new guidelines on Wednesday that could put millions more people on H.I.V. drugs than are now getting them. The recommendations could go a long way toward halting the epidemic, health officials say, but would cost untold billions of dollars not yet committed.”

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

“Roche skin cancer combination therapy gets EU panel backing,” Reuters

“Roche is expecting the European Commission this year to issue a final decision on a drug combination to treat advanced skin cancer, based on a drug panel’s positive opinion made public on Friday.”

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

“Amgen/Allergan’s Avastin biosimilar hits PhIII targets,” PharmaTimes

“A late-stage clinical trial has shown Amgen and Allergan’s biosimilar of Avastin (bevacizumab) to work just as well at staving off disease progression and improving survival in patients with non-small cell lung cancer.”

If you like this story, please see our blog titled “Optimizing Bioproduction Media to Improve Protein Production – A Discussion”

“HemoGenyx, a 43North winner, launches $200K crowdfunding campaign,” Buffalo Business Journal

“HemoGenyx, a Buffalo biotech company working on a therapy for the treatment of blood diseases and bone marrow failure has launched a $200,000 crowdfunding campaign.”

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

“MedImmune, 3M ink deal on next-gen cancer immunotherapy drug,” Washington Business Journal

“Gaithersburg-based biotech MedImmune and a division of 3M unveiled plans Friday to work together on a next-generation cancer immunotherapy drug.”

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

“Novartis launches portfolio for low- and low-middle-income countries,” Reuters

“Novartis AG launched a portfolio of 15 medicines to treat chronic diseases in low- and low-middle-income countries, the drugmaker said in a statement on Thursday.”

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”

“FDA approves Novo Nordisk’s long-awaited diabetes drug,” Reuters

“The U.S. Food and Drug Administration on Friday approved Danish drugmaker Novo Nordisk’s diabetes drug Tresiba, two years after rejecting the long-acting form of insulin.”

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