From Data to Dossier: Smart Scale-Up Solutions in Biopharmaceutical Manufacturing

A leading biopharmaceutical company focused on developing innovative solutions in drug development and delivery faced a significant challenge: they needed to accelerate critical scale-up initiatives under tight timelines with limited resources. To overcome this hurdle, they partnered with Sequoia Biotech Consulting, leveraging our expertise to develop an intermediate batch size and conduct essential process development studies and
characterization reports in line with their Validation Master Plan. Additionally, our team created a comprehensive Dossier for Module 3 Sections S.2.2, S.2.3, S.2.4, and S.2.5. This partnership not only addressed the client’s immediate scale-up needs but also enhanced their overall agility, positioning them for long-term success in a rapidly evolving market.