This week’s biotechnology news headlines include, setting the body’s serial killers loose on cancer, US Government shifts $81 million to Zika vaccine research, Vedanta and NYU aim for microbiome-based cancer immunotherapies, BMS to supply Opdivo for Bavarian Nordic Trial, Eleven Biotherapeutics inks multi-million dollar deal with Roche, EMA adopts new biologic biosimilar pharmacovigilance guidance, and FDA grants orphan drug designation to CD4CAR therapy for peripheral T-cell lymphoma.

Cell Culture Events

Workshops:

VISION leadership course is uniquely tailored for the bioindustry to capture the synergies between bioscience, technology and business practice – Keck Graduate Institute, Claremont, CA – September 14-16, 2016

UCL Biochemical Engineering in collaboration with Keck Graduate Institute is announcing its 2016 VISION Leadership Programme. Designed for talented high impact individuals, VISION provides executive leadership insights tailored for present & future leaders in the bioindustries through rigorous intellectual analysis & intensive, practical, peer-to-peer action-based learning giving you the tools required to drive innovation, entrepreneurship & global leadership in your organisation.

KEY BENEFITS AND IMPACT:

• Know how to make the transition from science & engineering based decision making towards company- wide strategic resolutions
• Build an invaluable network with elite peers & experts from academia & industry who challenge, stimulate & inspire you
• Gain perspectives on leadership challenges & critical business issues facing the bioindustry globally & formulate actions to address these
• Learn from real life cases studies to succeed in making difficult decisions & implementing strategies to secure a more robust future for your business
• Access & share best practices on how to be a good leader & avoid pitfalls in constantly evolving market
• Achieve your personal development & career objectives
• Evaluate the impact of key innovative research & technologies on the future of business & manufacturing

CONFIRMED SPEAKERS FOR 2016

Barry Buckland, CEO, BiologicB
Charles Cooney, Professor, MIT
Nigel Darby, former VP, GE Healthcare
Parrish Galliher, CTO, GE Healthcare
Phil Gomez, Principal, PricewaterhouseCoopers
Ljiljana Minwalla, Senior Legal & Patent Counsel, Mesoblast, Inc.
Andrew Ramelmeier, Senior VP, Portola Pharmaceuticals
Rahul Singhvi, COO, Takeda Vaccines

WHO SHOULD ATTEND

• Managers & practitioners fast tracked for executive roles or intending to move into leadership positions
• Current executives intending to interact with fellow leaders & expert speakers to debate & exchange novel thoughts & opinions
• Funding agencies wanting to interact with present & future thought leaders to gain insights into the sector trends & skills required to navigate the changing bioindustry landscape

 VISION combines innovative management thinking with cutting edge research to ensure high flyers perform optimally

For more information contact naveraj.gill@ucl.ac.uk and visit www.ucl.ac.uk/biochemeng/visionprogramme

Webinars:

The Role of Exosomes in Inflammatory Disease: Pathogenesis and Treatment

Date: Thursday, September 22, 2016

Time: 02:30 PM Eastern Daylight Time

Duration: 1 hour, 30 minutes

Exosomes encapsulate and transport a wide variety of molecules generated by their cell-of-origin, a process now thought to be a form of cellular signaling. Exosome signaling is common across cell types and species, but it is of particular interest in diseases with an inflammatory component. While exosome isolation and analysis is useful to understanding the mechanisms behind these multifaceted diseases, exosomes may also be exploited for their therapeutic potential. The Scientist is bringing together a panel of experts to review the current knowledge on exosomes in inflammation, and to explore the potential for exosome-based therapeutics. Attendees will have the opportunity to interact with the experts, ask questions, and seek advice on topics that are related to their research.

Topics to be covered:

• The exosomal cargoes released during inflammation, and their potential as therapeutic targets
• How inflammatory diseases are uniquely suited to exosome analysis

Register here

Bioprocess Insights Webinars

The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the overall business strategy.

In this webinar series, four renowned subject matter experts will share their insights into four areas of bioprocessing: upstream, vaccines, downstream, and single-use technology. We will present tangible, recently developed data that can help you in developing modern, cost-efficient, and sustainable bioprocesses.

Don’t miss these on demand webinars – http://www.bioprocessintl.com/sponsored-content/bioprocess-insights-webinars/

Conferences:

August

• The Bioprocessing Summit – August 15-19, 2016 – Westin Boston Waterfront– Boston, MA http://www.bioprocessingsummit.com/

If you are attending, please don’t miss:

Dr. Adam Elhofy, CSO, Essential Pharmaceuticals (Booth #303) is giving a seminar on Thursday, August 18^th at 9:00 am entitled:  “Bioproduction: Scale, Bioreactors & Disposables” and is presenting a poster titled “Novel Lipid supplement increases mAb production in single use bioreactors”.

Abstract: Optimizing protein production by CHO cells grown in serum free conditions is an ongoing process, requiring a balance between cell proliferation and protein production. Many tools are utilized to increase protein titers, like metabolomics, media optimization and continuous perfusion. We investigated the use of a novel lipid supplement to improve media conditions using various strategies to increase protein yield. One strategy of adding the lipid supplement at the initiation of culture resulted in an increase in monoclonal (mAb) titer of 30% from CHO cells without increasing viable cell density (VCD). Furthermore when the metabolic profile was examined there were no differences in any of the metabolites tested, including ammonia, glutamate, lactate, glucose and others. A second strategy of using the supplement in a fed batch process as a feed resulted in two notable effects. The first effect was increasing the titer yield by close to 25%. The second effect was extending the window for peak protein production from 1 day to 2 days. The supplement was also used in a single use bioreactor. The lipid supplement used as a feed in a Wave bioreactor resulting in an increase of 27% of mAb titer. This research using this lipid supplement is the first to show an increased titer in a single use bioreactor. These results show there are opportunities for further optimization of protein production using lipids. Furthermore some of the standard metrics like metabolic profiles may not be able to predict improved titer or productivity. It is possible the use of lipids alters energy utilization for de novo membrane formation and improves the energy efficiency for protein production as evidenced by the scalable small bioreactor results.

Dr. Elhofy was recently interviewed for the Cell Culture Dish Podcast, “Cell Culture Media Optimization – It’s about more than just high protein titer.”

September

• BioAnalytical and Formulaiton Summit – September 14-15, 2016 – Berlin, Germany https://lifesciences.knect365.com/bioanalyticalandformulationThe Bioanalytical & Formulation Summit provides the ultimate opportunity to discuss your current challenges in analytical methods for biologics, with 2 streams dedicated to:
  • Protein Characterisation and Post Translational Modifications
  • Formulation for Biologics

  Join your peers for expert insight, new data, and the latest technology updates for formulation and QC strategies, to inform your methods and improve your product quality and efficacy.

October

• Bioprocessing International Co-Located with Cell Therapy Bioprocessing – October 4-7, 2016 – Boston Convention Center and Exhibition Center – Boston, MA http://www.ibclifesciences.com/BPI/overview.xml

• World Vaccine Congress Europe – October 10-12, 2016 – Barcelona, Spain http://www.terrapinn.com/conference/world-vaccine-congress-europe/index.stm

• Adoptive T-Cell Therapy Summit Europe 2016 – October 10-11, 2016 – London, UK www.tcellsummit.com

• Bioproduction – October 14-15, 2016 – Dublin, Ireland http://www.informa-ls.com/event/bio-production14

November

• 2^nd Annual Cell & Gene Therapy Congress – November 3-4, 2016 – London, UK – http://www.celltherapy-congress.com/Over 250 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions.Over 20 presentations and case studies focused on the key issues in cell & Gene Therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing

  2 interactive streams:

  Cell & Gene Therapy: Development, Clinical Trials & Commercialisation

  Cell Therapy Bioprocessing and Manufacturing

  Co-located with the established 5th Annual Cell Culture & Bioprocessing Congress and 3rd Annual Stem Cell Congress

  Free Pre-Congress Webinar

  Advances In Gene Editing Technologies
  Presented by Richard Morgan, Vice President, Immunotherapy at Bluebird Bio. – Register for free today >>

• 5th Annual Cell Culture & Bioprocessing Congress – November 3-4, 2016 – London, UK – http://www.cellculture-congress.com/Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production

  4 interactive streams:

  Early Cell Line Development

  Process Development

  Late Stage Cell Line Development

  Biological Production

  14 pre-scheduled one to one meetings, exhibition and informal networking opportunities

  Co-located with our 3rd Annual Stem Cell Congress and our 2nd Annual Cell & Gene Therapy Congress

• TIDES Europe – November 14-17, 2016 – Berlin, Germany – http://get.knect365.com/tides-europe/TIDES Europe is the place where oligo and peptide experts go to meet and build successful partnerships to accelerate products from early discovery through late stage development and commercialisation. In 2015 Tides Europe attracted a 40% increase in attendance across the oligo and peptide audience.
• World Immunotherapy Congress 2016 – November 14-16, 2016 – Basel Switzerland http://bit.ly/1rbnrYy

• World Precision Medicine – November 14-15, 2016 – Washington DC

The World Precision Medicine Congress USA is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as precisionFDA and NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there.

Can you afford to miss this gathering of precision medicine leaders? Pharma, big data, and healthcare providers will be there attending sessions on Gene Therapy, Cell Therapy, personalized medicine, and genomics.

Download the brochure: http://bit.ly/1N3Y0vI

Register to attend: http://bit.ly/1ObpkNV

December

• ASCB – December 3-7, 2016 – San Francisco, CA http://ascb.org/meetings/

• World Stem Cell Summit & RegMed Capital Conference– December 6-9, 2016 – West Palm Beach, Florida http://worldstemcellsummit.com/

• Antibody Engineering and Therapeutics – December 11-15, 2016 – San Diego, CA http://www.ibclifesciences.com/AntibodyEng/overview.xml

• Global Biomanufacturing Summit – December 12-14, 2016 – San Diego, CA http://biomansummit.com/

Headlines:

“Setting the Body’s ‘Serial Killers’ Loose on Cancer,” The New York Times

“The young surgeon was mystified. A fist-size tumor had been removed from the stomach of his patient 12 years earlier, but his doctors had not been able to cut out many smaller growths in his liver. The cancer should have killed him, yet here he lay on the table for a routine gallbladder operation.”

If you like this story, please see our blog titled “Poster: Flow Electroporation Provides a Highly Efficient, Flexible and Scalable Transient Protein Expression System”

“U.S. government shifts $81 million to Zika vaccine research,” Reuters

“The U.S. Department of Health and Human Services has shifted $81 million in funds from other projects to continue work on developing vaccines to fight Zika in the absence of any funding from U.S. lawmakers.”

If you like this story, please see our blog titled “Cool Tool –Smart Cell Culture Monitoring, Transform single cell parameters into cell culture intelligence”

“Vedanta, NYU aim for microbiome-based cancer immunotherapies,” Fierce Biotech

“Vedanta Biosciences has partnered with the NYU Langone Medical Center to develop microbiome-derived immunotherapies specifically for use paired with checkpoint inhibitors. The idea is to use the microbiome to help improve the efficacy of this major developing class of oncology drugs as well as, potentially, for standalone use to treat cancer.”

If you like this story, please see our blog titled “Cool Tool – Aramus Single Use Bag Assembly – Provides Advantages over Existing Storage and Transportation of Intermediate and Drug Substance”

“BMS to supply Opdivo for Bavarian Nordic trial,” PharmaTimes

“Bristol-Myers Squibb has agreed to supply Bavarian Nordic with Opdivo for use in a clinical trial assessing the immunotherapy in combination with experimental drug CV301.”

If you like this story, please see our blog titled “Increase Protein Yield by Striking the Right Balance between Cell Density and Protein Productivity”

“Eleven Biotherapeutics Inks Multi-, Multi-Million Dollar Deal with Roche,” Genetic Engineering News

“Eleven Biotherapeutics granted Hoffmann-La Roche an exclusive, worldwide license to develop and commercialize EBI-031 and all other interleukin-6 (IL-6) antagonist antibody technology owned by Eleven. EBI-031 is a humanized monoclonal antibody that binds IL-6 and inhibits all known forms of IL-6 cytokine signaling, according to Eleven Biotherapeutics.”

If you like this story, please see our blog titled “Reduce Cell Line Development Time by 30% and Simplify Proof of Clonality – A Case Study”

EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance, Regulatory Focus

“The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016.”

If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”

“FDA grants orphan drug designation to CD4CAR therapy for peripheral T-cell lymphoma,” Healio

“The FDA granted orphan drug designation to iCell Gene Therapeutics for its chimeric antigen receptor-engineered T cells directed against the target protein CD4 to treat peripheral T-cell lymphoma.”

If you like this story, please see our blog titled “Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation”