Search results for " eu"

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Prokaryotes contain only a single chromosome; eukaryotes have more than one, made up of a complex of DNA, RNA, and protein. The exact number of chromosomes is species-specific. Humans have 23 pairs.  …

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Early biotechnology products in the US and Europe were characterized by low titers and low cell densities using various cell hosts (1, 2). Most companies had few recombinant products licensed or in de…

Article Single-Domain Antibodies for Brain Targeting
Flajnik, Eur J Immunol, 35 (3) 936-45 (2005). 13. V.A. Streltsov et al., Proc Natl Acad Sci USA, 101 (34) 12444-49 (2004). 14. B. Stijlemans et al., J Biol Chem, 279 (2) 1256-61 (2004). 15…

Article Reimagining Affordable Biosimilars
EU is European Union. Regulatory transformations The regulatory landscape for biosimilars has seen many changes to requirements of preclinical and clinical subjects, reliance on analytical…

Article Continuous Manufacturing: A Changing Processing Paradigm
GlaxoSmithKline’s new hybrid continuous-batch synthesis manufacturing plant in Jurong, Singapore—announced in October 2014 and predicted to open in 2016—cost 19 million euros (approximately $25 millio…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
Vilasrao Kadam, Eurasian J. Anal. Chem. 5, 187–203 (2010). 52. T. Schmid et al., Environ. Sci. Technol. 36, 4135–4141 (2002). 53. http://pharma.metrohm.com/pdfdownload/Prosp_Pharma_Analytik_e_…

Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
To date, several facilities have successfully eliminated or reduced area classifications with approval by US and European Union authorities. Significant benefits will be achieved by building on these …

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
Welin, EU Regulatory Feedback, presentation at ISPE meeting (Brussels, Sept. 2010). 11. J.A.C. Lim et al., Bioprocess Int. 8 (10), 62–70 (2010). 12. B. Junker, BioPharm Int. 22 (5), 40–50 (200…

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