At Biotech Week Boston this year, we spoke to a whole range of experts leading the way in their fields. Here we’ve gathered all seven of the in-depth interviews exploring cutting- edge research on everything from mAb manufacturing, to the future of food, to big data, to the ‘microbiome organ’.
Designing the foods of the future – David Edwards, Professor of the Practice of Idea Translation, Harvard School of Engineering and Applied Sciences
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Preuse post-sterilization integrity testing (PUPSIT) is recommended by most regulators for critical sterilizing liquid filters used in aseptic processing. A preuse test before sterilization will confirm that a filter is installed properly and was not damaged during shipment or handling. Performing a preuse test afterward can detect damage from the sterilization cycle itself. That can limit risk, making it current industry practice especially for products marketed in the European Union. But such testing can be difficult without breaching system sterility.
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It has now been almost four years since the FDA introduced its Breakthrough Therapy Designation, and yet a certain air of mystery still surrounds it. Indeed, just this week, the FDA itself released a Q&A to “help readers understand not only the lingo, but also the implications of expedited reviews and approvals”.
At BioProcess International European Summit 2016, Merck Executive Director of Biologics Process Development and Commercialisation Gargi Maheshwari told of her experience of working on one of the biggest successes of the accelerated approval programme; KEYTRUDA.
The drug gained market approval a little over a year after being named a breakthrough therapy, and Dr Maheshwari highlighted how “the timelines that we had to work with were very different to the traditional pharma timelines of up to 10 years”, which inevitably created a lot of challenges.
Continue reading “No substitute for strong science: Breakthrough Therapy Designation success story”