Search results for " eu"
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
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
Maximum Output Starts with Optimized Upstream Processing
KBI Biopharma, for instance, is implementing a global expansion strategy that includes bringing online new clinical and commercial manufacturing facilities in the United States and Europe.Vibalogics i…
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
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
… banks (MCB) for the MAA as recommended by ICH Q5B guidance, it was only recently recommended by the European Medicines Agency (EMA) that the sequence of the coding region should be confirmed prior t…
Article
N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…