Wednesday, September 11, 2019 Daily Archives

CGT CMC: Plan ahead, avoid comparability studies says Novartis

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Making changes to the manufacturing process for cell and gene therapies is possible but cumbersome due to the need to perform comparability studies, says a Novartis veteran. Speaking at the Cell & Gene Therapy Bioprocessing & Commercialization conference – part of Biotech Week Boston – this week, Novartis’ Sergio Fracchia advised developers of advanced therapies to think about their manufacturing needs several years in advance to avoid future pitfalls. Specifically, Fracchia – who serves as Global regCMC Director, Cell and…

September 11, 2019

Scancell adds first partner for high potent MAb tech

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Immuno-oncology firm Scancell has begun offering its AvidiMab technology to partners looking to increase the potency of their monoclonal antibody pipelines. Scancell has its own pipeline of monoclonal antibodies (MAbs) targeting novel cancer treatments, but this deal represents the first collaboration with an external partnerover its AvidiMab technology. “AvidiMab is proprietary technology to enable the modification of the constant region (FC) of a human antibody to allow direct tumor killing of antibodies directed to tumor associated antigens (TaGs) but may…

September 11, 2019

ABEC breaks plastic ceiling again with 6,000 L single-use bioreactor

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ABEC has launched a single-use bioreactor system with a working volume of 6,000 L – three times that of industry’s standard upper limit. While single-use bioreactors are a staple in the industry these days, one of the commonly discussed limitations of such systems in a commercial setting are their size. Most vendors offer bioreactors of 2,000 L as their upper limit leaving biomanufacturers to either run several systems in unison or opt for stainless-steel tanks if requiring larger volumes. But…

September 11, 2019