Search results for " biopharms"

Article FDA Approves First Biosimilar
Mar 06, 2015 By Randi Hernandez BioPharm International FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…

Article Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe. Feb 01, 2015 By Sean Milmo BioPharm International The European Medicines Agency (EMA) has r…

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 Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies. Sep 1, 2014 By: Jane Wan BioPharm International Volume 27, Issue 9, pp. 8-12  On March 25, 2014, the…

Article Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development. Sep 1, 2014 By: Thomas A. Little, PhD BioPharm International Volume 27, Issue 9, pp. 46-49 A product’s or proc…

Article Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough. Aug 1, 2014 By: Eric Langer BioPharm International Volume 27, Issue 8, pp. 12-14 Contract manufacturing organizations (CMOs) shou…

Article Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization. The characterization of proteins involves identification of their complex …

Article Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions. Few FDA officials discuss pharmaceutical regulation these days without …

Article Biopharma Moves to Integrated, Single-Use, Downstream Processing
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities. A lack of single-use technologies The greatest barrier for adoption …

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