Moore R, Cubbon S, Blank M, Bones J. Is high resolution mass spectrometry the missing piece in continuous bioproduction?
Posted: 7 September 2017 | | No comments yet
1. Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004). Accessed online 27/06/2017. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm0 70305.pdf.
2. Adamo A, et al. On‐demand continuous‐flow production of pharmaceuticals in a compact, reconfigurable system. Science. 2016;357(6281):61‐67.
3. Walther J, et al. The business impact of an integrated continuous biomanufacturing platform for recombinant protein production. Journal of Biotechnology. 2015;213:3-12.
4. Konstantinov KB, Cooney CL. White Paper on Continuous Bioprocessing, May 20-21, 2014 Continuous Manufacturing Symposium. Journal of Pharmaceuticals Sciences. 2015;104(3):813-820.
5. Smart Sensor Capsule. The Medicine Maker. Accessed online 27/06/17 https://themedicinemaker.com/issues/1115/smart‐sensor‐capsule/
6. Ding W. Risk‐based scientific approach for determination of extractables/leachables from biomanufacturing of antibody‐drug conjugates (ADCs). Methods Mol Biol. 2013;1045:303‐11.
7. Rogers RS, et al. Development of a quantitative mass spectrometry multi‐attribute method for characterization, quality control testing and disposition of biologics. mAbs; 2015;7(5):881‐890
8. ICH. Guidance for Industry: Q8 (R2) Pharmaceutical Development. 2009.
9. ICH. Guidance for Industry: Q9 Quality Risk Management. 2006.
10. ICH. Guidance for Industry: Q10 Pharmaceutical Quality System. 2009.
11. ICH. Guidance for Industry: Q11 Development and Manufacture of Drug Substances. 2012.
12. Yu L, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16:771‐783.