Search results for " industry 4.0"

Article Re-use of Protein A Resin: Fouling and Economics
Mar 01, 2015 By Anurag S. Rathore, Mili Pathak, Guijun Ma, Daniel G. Bracewell BioPharm International Volume 3, Issue 28 In the past two decades, Protein A affinity chromatography ha…

Article New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes. Nov 1, 2014 By: Jill Wechsler BioPharm International Volume 11, Issue …

Article Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability. Sep 2, 2014 By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…

Article Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design. Sep 1, 2014 By: Susan Haigney BioPharm International Volu…

Article Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain. Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…

Article Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…

Article Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear. (Dmitry Rukhlenko/Getty Images) On July 1, India's new…

Article Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results. By: Simon Chalk BioPharm International There is a high degree of consensus in the biomanuf…

Article Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles. The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…

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,…

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