How to avoid common contamination control mistakes in new aseptic facilities - Pharmaceutical Technology

As soaring biologics demand drives new aseptic facility construction, manufacturers face stricter regulatory scrutiny. As soaring biologics demand drives new aseptic facility construction, manufacturers face stricter regulatory scrutiny. Image: Shutterstock Rising biologics approvals worldwide are driving demand for sterile manufacturing infrastructure. GlobalData reports that approvals increased from 106 in 2015 to 210 in 2025, with biologics now account for 53% of Phase III drug candidates. In tandem, 101 new biologics manufacturing projects were announced in 2025 – a 71% increase from 2023. However, unlike small molecules, biologics present unique challenges for aseptic facilities. Regulatory reforms have further raised requirements. The…

Source: Pharmaceutical Technology