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Beyond API monitoring – Kaiser Optical Systems

9 February 2018 | By

Esmonde-White, K. A., Cuellar, M., Uerpmann, C., Lenain, B., & Lewis, I. R. Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing. Anal. Bioanal. Chem. 409, 637–649 (2016). Strachan, C. J., Rades, T., Gordon, K. C. , & Rantanen, J. Raman spectroscopy for quantitative analysis of pharmaceutical…

Moore R, Cubbon S, Blank M, Bones J. Is high resolution mass spectrometry the missing piece in continuous bioproduction?

7 September 2017 | By

REFERENCES 1. Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004). Accessed online 27/06/2017. 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…

Fahrzi B, Cetinkaya C. Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. 2017;22(4):36-40

7 September 2017 | By

REFERENCES 1. Rodriguez ML, McGarry PJ, Sniadecki NJ. Review on cell mechanics: experimental and modeling approaches. Applied Mechanics Reviews. 2013;65:060801. 2. Johnson KL, Kendall K, Roberts AD. Surface energy and the contact of elastic solids. Proceedings of the Royal Society of London A: Mathematical, Physical and Engineering Sciences. The Royal…

Panofen D, Pandolfi D, Denoya C. Compressed gases: an important component of an environmental monitoring programme. 2017;22(4):16-20

7 September 2017 | By

References (2013). Microbiological Control and Monitoring of Aseptic Processing Environments. Chapter <1116>. 784-794. Rockville, MD, USA. Denoya C, Reyes J, Ganatra M, Eshete D. Rapid Sterility Testing using ATP Bioluminescence-based PallChek Rapid Microbiology System. Rapid Sterility Testing (J. Moldenhauer Ed.). 2011. Chapter 17, 433-461, DHI/PDA. Bethesda, MD, USA. Denoya C.…

Eissa M. Microorganisms and a new horizon of scientific discoveries. European Pharmaceutical Review. 2017;3:68-70

12 July 2017 | By

References 1. Madigan M, Martinko J, Parker J. Brock biology of microorganisms. Upper Saddle River, NJ: Prentice Hall/Pearson Education; 2003. 2. Extremophilic Bacteria and Microbial Diversity [Internet]. 2016 [cited 21 July 2016]. Available from: /raven06b/enhancementchapters/raven30_enhancement.html 3. Muruga, Bancy N. The diversity of extremophilic bacteria in Lake Magadi, Kenya.…

Miller M. The regulatory acceptance of rapid microbiological methods. European Pharmaceutical Review. 2017;3:55-58

12 July 2017 | By

References European Medicines Agency. Inspectors Working Group. Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. EMA/INS/GMP/489331/2016 GMP/GDP. 2016. Alternative Methods for Control of Microbiological Quality, European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa. 2017; Chapter…