Search results for " sourcing"
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
EMA Invites Comments on New Guidance for Vaccine Development
The European Medicines Agency (EMA) has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical req…
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
Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
There is a clear link between a country’s rate of economic development and the strength of its intellectual p…
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Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
In a new report on the global biosimilar drugs market, Biosimilars: Parsing the Industry's Pipelines, Moody's Investors Service reports that while biosimilar products have been launched in Asia and …
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …