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The caking challenge: Are granulated materials a good way to overcome it?

mAb, ADC, recombinant / By

It’s a familiar scenario: opening a package of bulk material that’s been in storage for a while only to find it has formed clumps, caked together, or – at worst – even completely solidified. A lot of biopharma businesses have learned to simply deal with this irritation. The question is, can they afford to – […]

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3 Keys to Virus Risk Mitigation for Biopharmaceuticals

mAb, ADC, recombinant / By

Start Early Developing and manufacturing a biopharmaceutical drug is a complex mission . Throughout development, teams working on drug candidates go through various phases of risk mitigation strategies. This encompasses simple risk assessments during development, to detailed Failure Modes and Effects Analysis (FMEA) during process validation. One specific risk to become very familiar with is

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