Alexander Schuhmacher

Dec 4, 2024 | sciencedirect.com | Yan Gao |Haiyang Hu |Alexander Schuhmacher |Eloy Lozano baró

Section snippets Quality by design (QbD) implementation with nondestructive techniques According to the current good manufacturing practice (cGMP) requirements, the implementation of QbD methodologies coupled with process analytical technology (PAT) allows for efficient manufacturing of drug products with the desired quality for patient benefits (Figure 1, Figure 2).(p6) In the context of batch manufacturing of pharmaceutical drug products, the desired quality with net-zero loss is possible...

Sep 18, 2024 | diwou.com | Alexander Schuhmacher

The pharmaceutical industry is well known for being one of the most inefficient industries globally. Numerous studies, including Steve Paul’s famous 2010 paper, the Tufts Cost study, and multiple landmark papers from the St. Gallen Consortium led by Oliver Gassmann and Alexander Schuhmacher, have provided detailed productivity analyses of internal pharma R&D and collaborations.