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9 February 2018

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…

7 September 2017

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. 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…

7 September 2017

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…

7 September 2017

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.…

12 July 2017

Jenke D. Strategic aspects of change control. European Pharmaceutical Review. 2017;22(2):60-62

12 July 2017 | By

References Arbin A, Jacobsson S, Hanninen K, Hagman A, Ostelius J. Studies on the contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques. Int J Pharm. 1986;28(2-3):211-218. Goydan R, Schwope AD, Redi RC, Cramer G. High-temperature migration of anti-oxidants from polyolefins. Food Additives and Contaminants.…

12 July 2017

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]. Mhhe.com. 2016 [cited 21 July 2016]. Available from: www.mhhe.com/biosci/genbio/raven6b/graphics /raven06b/enhancementchapters/raven30_enhancement.html 3. Muruga, Bancy N. The diversity of extremophilic bacteria in Lake Magadi, Kenya.…

12 July 2017

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. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211657.pdf Alternative Methods for Control of Microbiological Quality, European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa. 2017; Chapter…

12 July 2017

Carnell-Morris P, Kaszuba M, Pothecary M. Analytical techniques for faster development of drug delivery systems. European Pharmaceutical Review. 2017; 44-46

12 July 2017 | By , ,

References Global Markets and Technologies for Advanced Drug Delivery Systems BCC Research Reports PHM006K. March 2016. www.bccresearch.com/market-research/pharmaceuticals/advanced-drug-delivery-systems-tech-markets-report-phm006k.html [Accessed 08 November 2016]. Drug Delivery Systems: Getting Drugs to Their Targets in a Controlled Manner. National Institute of Biomedical Imaging and Bioengineering www.nibib.nih.gov/science-education/science-topics/drug-delivery-systems-getting-drugs-their-targets-controlled-manner [Accessed 8 November 2016].

12 July 2017

Laffleur F. Mucosal delivery – is this the next level in drug delivery?. European Pharmaceutical Review. 2017;3:38-40

12 July 2017 | By

References Laffleur F. Thiomers, mucoadhesion and oral delivery of biomacromolecules. Curr. Drug ther. [Internet]. 2014;9:56-62. Kharenko EA, Larionova NI, Demina NB. Mucoadhesive drug delivery systems (Review). Pharm. Chem. J. 2009. p200-8. Boddupalli B, Mohammed Z, Nath R, Banji D. Mucoadhesive drug delivery system: An overview. J. Adv. Pharm. Technol. Res.…

12 July 2017

Courtney P et al. Freeze-dried formulations: a new perspective on reformulating naloxone. European Pharmaceutical Review. 2017;3:32-36

12 July 2017 | By , , , ,

References National Institute on Drug Abuse: Overdose Death Rates, https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/national-overdose-deaths2015.pdf (Accessed 24 February 2017) www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2015/estimated-deaths-for-the-four-major-cancers-by-sex-and-age-group-2015.pdf Strang J, Bird SM, Parmar MKB. Take-Home Emergency Naloxone to Prevent Heroin Overdose Deaths after Prison Release: Rationale and Practicalities for the N-ALIVE Randomized Trial. Journal of Urban Health-Bulletin of the New York Academy of…

12 July 2017

Bhardwaj V, Gaur V. Raman spectroscopy as a blood glucose monitoring tool. European Pharmaceutical Review. 2017;3:26-29

12 July 2017 | By ,

References International Diabetes Federation. About diabetes, facts and figures 2015 to 2040. Available at: www.idf.org/about-diabetes/what-is-diabetes. Angaran DM, Smith DS, Birnbaum M. The use of urine test for indirect estimation of blood glucose levels in the critically ill. American Journal of Hospital Pharmacy.1980;37:950-956. Clarke SF, Foster JR. A history of blood…

12 July 2017

Lankers M, Valet O, Laskina O. Subvisible particle identification in protein-based formulations by Raman spectroscopy. European Pharmaceutical Review. 2017;3:22-24

12 July 2017 | By , ,

References Strehl, R, Rombach-Riegraf V, Diez M, Egodage K, Blueme, M, Jeschke M, Koulov A. Discrimination between silicone oil droplets and protein aggregates in biopharmaceuticals: a novel multiparametric image filter for sub-visible particles in microflow imaging analysis. Pharmaceutical Research. 2012;29(2):594-602. Siska C, Pierini C, Lau H, Latypov R, Fesinmeyer R,…

12 July 2017

Gerstberger I, Liebmann M. Regulation of orphan drugs within the EU. European Pharmaceutical Review. 2017;3:14-16

12 July 2017 | By

References Cf. Straeter/Burgardt/Bickmann, Arzneimittel für seltene Leiden – Situation in der Europäischen Union, A&R 2014, 195 with further references. Recital 2 of Regulation (EC) No 141/2000. See also Hiltl, Orphan Drugs – Zwischenbilanz und Konfliktfelder, PharmR 2001, 308. Regulation (EC) No 141/2000 of the European Parliament and of the Council…

12 July 2017

Elder D. Separation and purification applications for mutagenic impurities. European Pharmaceutical Review. 2017;3:64-67

12 July 2017 | By

References Fujiwara M, Nagy ZK, Chew JW, Braatz RD. First-principles and direct design approaches for the control of pharmaceutical crystallization. J. Proc. Control. 2005;15:493-504. ICH M7, 2014. Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. Current Step 4 version. 23 June 2014. Teasdale…

12 July 2017

Jacobsen NW, Nielsen LD. Two-dimensional liquid chromatography (2D-LC) with multiple heart-cutting in a troubleshooting laboratory. European Pharmaceutical Review. 2017;3:60-63

12 July 2017 | By ,

  References Stoll DR, Li X, Wang X, Carr PW, Porter SEG, Rutan SC. Fast, comprehensive two-dimensional liquid chromatography, J Chromatogr A. 2007;1168(1–2):3-43. doi:10.1016/j.chroma.2007.08.054. Pursch M, Buckenmaier S. Loop-based multiple heart-cutting two-dimensional liquid chromatography for target analysis in complex matrices. Anal Chem. 2015;87(10):5310-7. doi: 10.1021/acs.analchem.5b00492. Chen M, Wang L, Dong…

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