1. MatsLundgren(2021)Meeting the process development challenges of a diverse biologic pipeline: how to navigate the evolving biopharmaceutical landscape from a process development standpoint. White Paper Cytiva See also:https://www.cytivalifesciences.com/en/us/solutions/bioprocessing/knowledgecenter/new‐drug‐process‐development.
2. EMA(2017) Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. Rep. from the EMA‐FDA QbD pilot program. EMA/213746/.
3. U.S. Food and Drug Administration (2004) FDA PAT – a framework for innovative pharmaceutical development manufacturing and quality assurance: guidance for industry.