Wednesday, September 25, 2019 Daily Archives

Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

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The blockbuster success of antibody-based therapeutics for autoimmune diseases, inflammatory diseases and immuno-oncology accelerated the high stakes monoclonal antibody (mAb) development race. Clone selection is a significant upstream bottle-neck slowing bench-to-bedside development progress for new mAb-based therapeutics. Cy-Clone™ PLUS, a validated assay kit accelerates human mAb production cell-line generation, significantly reducing the time to industrial-scale productivity. Cy-Clone PLUS assay combined with the Intellicyt® iQue platform and integrated ForeCyt® Software are powerful analytical tools that inform rapid go/no-go decisions with multiparameter,…

September 25, 2019

Update: Thermo Fisher scaling single-use bioreactors up to 5,000 L

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There is increasing demand for large-scale single-use bioreactors says Thermo Fisher as it prepares to launch disposable systems up to 5,000 L in volume. Thermo Fisher Scientific showcased its latest bioprocess offerings at Biotech Week Boston earlier this month. This included an update to its HyPerforma DynaDrive single-use bioreactor (SUB) range, which will see the firm offer biomanufacturers disposable bioreactors with volumes more than doubling its current volume limit. Single-use technologies have been fully adopted by the industry, but most…

September 25, 2019

GSK pays Immutep on advancement of Ab for Ulcerative Colitis

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The first patients have been dosed in a Phase II trial for GSK2831781, GSK’s ulcerative colitis candidate based on Immutep’s depleting anti-LAG antibody technology. In 2010, GlaxoSmithKline (GSK) licensed ImmuTune-IMP731, a therapeutic antibody for the treatment of autoimmune diseases, from Immutep in a deal that included milestone payments of £64 million ($80 million). This week, GSK is paying out £4 million of this due to the first patient being dosed in GSK’s Phase II clinical trial evaluating the candidate –…

September 25, 2019

Biocon buys Pfizer R&D plant to bolster 28-strong biosimilar pipeline

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Biocon has acquired an R&D plant in Chennai from Pfizer healthcare India and plans to set up the 60,000 square-foot space to support its 28 molecule-strong biosimilar pipeline. Financial details of the acquisition have not been divulged, but a spokesperson from Indian drugmaker Biocon told this publication it has “acquired R&D capital assets from Pfizer healthcare India Ltd.†Specifically, this is a 60,000 square-foot facility at the TICEL Bio Park in Chennai, India, which will be established as a “bench…

September 25, 2019

Novavax poised to step up to Executive Order with recombinant flu vaccine

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President Trump has called for the modernization of influenza vaccine manufacturing. With its recombinant vaccine NanoFlu set to enter Phase III, Novavax says it offers the solution. Last week, the White House issued an ‘Executive Order [EO] on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health’ (reprinted below) aimed at addressing the “critical shortcomings†in the manufacture of such products. “Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires…

September 25, 2019