1. FDA.Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance. Rockville MD: US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Veterinary Medicine Office of Regulatory Affairs;2004.
2. ICH harmonised tripartite guideline. Guidance for industry: Q8(R2) pharmaceutical development. In:International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use August2009.
3. European Medicines Agency. ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities). ICH guideline Q11 on development and manufacture of drug substances (chemical Q4 entities and biotechnological/biological 2011). In:ICH Harmonised Tripartite Guideline. Guidance for Industry: Q11. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use May2012.
4. Process analytical technology (PAT) for biopharmaceutical products
5. Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe