Search results for " Biopharm"
Article
FDA Approves First Biosimilar
She said that some biopharma companies fail to establish a strong foundation of analytical data to ensure sufficient similarity, and may have to redo pharmacology studies and other trials as a result.…
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Labeling of Biosimilars
Critics of EMA’s policy on the issue, led by the European Biopharmaceutical Enterprises (EBE) and the European Association of Bio-industries (EuropaBio), claim that it is too close to that on the labe…
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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 …
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Continued Process Verification for Biopharma Manufacturing
A group of more than 20 companies collaborated on this topic, using the facilitation services of the BioPhorum Operations Group (BPOG), to generate a detailed example of how CPV for a biopharma manufa…
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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…
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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…
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Relationship Building at Top of Mind for Clients
As results from BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) show, however, it’s no longer enough for CMOs to lay claim to technolog…
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Analyzing Proteins Using SEC, MALS, and UHPLC
Challener is a contributing editor to BioPharm International.
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Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
Drivers for adoption
The success that biopharmaceutical manufacturers have had with single-use technologies for upstream applications is providing significant impetus for their application to down…