Thursday, July 25, 2019 Daily Archives

A Start-Up Sourcebook: How to Jump Five Unforeseen Hurdles to Biotech Success

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The purpose of this panel discussion, which concluded the Tuesday BPI Theater sessions at BIO, was to introduce a new eBook, How to Jump Five Unforeseen Hurdles in Biotech Success, edited by Lisa LaMotta. Other contributors to the eBook — Ramani Varanasi (X-Biotix Therapeutics), Chris Haskell (Bayer Healthcare), Dan Geffken (Danforth Advisors), Luba Greenwood (Google’s Verily), Ailis Tweed-Kent (Cocoon Biotech), and Teresa Lavoie (Fish & Richardson) — joined LaMotta on this panel to explore ways of building an intellectual property…

July 25, 2019

Gene Therapy Product Analytics: Where Historical and Modern Techniques Meet

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On Tuesday, 4 June 2019, Andy Topping, chief scientific officer of FUJIFILM Diosynth Technologies, spoke to the BPI Theater at BIO about analytical methods for viruses and gene therapy products. Effective analysis, he argued, requires methods from both classic and contemporary virology, as well as means that have long been used for more traditional biologic products. Even basic questions about a gene therapy product —  about how much product you have made, how many vials have been filled, and what…

July 25, 2019

Alexion on track with FcRn antibody after manufacturing hitch

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After inheriting an impurity in the drug product of early-phase antibody ALXN1830, Alexion Pharmaceuticals says new batches will be available by the end of the year. In November 2018, Alexion Pharmaceuticals acquired Syntimmune in a deal worth up to $1.2 billion, adding ALXN1830, a clinical-stage humanized monoclonal antibody that inhibits the interaction of neonatal Fc receptor (FcRn) in trials for warm autoimmune hemolytic anemia (WAIHA) and generalized myasthenia gravis (gMG). But earlier this year, the firm discovered an issue in…

July 25, 2019

Lonza building out capacity to prep for ADC boom

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CDMO Lonza already supports three of the five commercially available antibody-drug conjugates (ADCs) and is adding two news suites in Switzerland in preparation of future demand. Contract development and manufacturing organization (CDMO) Lonza will expand its bioconjugation facility in Visp, Switzerland in readiness for a new wave of antibody-drug conjugates (ADCs) coming through the clinic. “Many bioconjugates are on expedited programs and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and…

July 25, 2019

Politics, patents and pricing: the future of the US biosimilars market

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In the US the ongoing political debate about patents and prices will determine the long-term viability of the US biosimilars market, says an industry expert. The US biosimilar drug market was established in 2015 with the approval of Zarxio, Sandoz’s version of the Amgen drug Neupogen (filgrastim). Zarxio quickly established itself – the drug accounted for 45% of all the short-acting filgrastim used in the US last year. In contrast, the wider market has been slow to develop. Legal complexity…

July 25, 2019