Search results for " Biopharm" in Articles / App Notes
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Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the jo…
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The Affordable Care Act's Impact on Innovation in Biopharma
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharmaceutical companies scrambling to understand how their business model, including its ability to innovate, will chang…
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EMA Collaborates with HTA Assessment Networks
The licensing of a new drug is only a preliminary step in what can be a lengthy and complex procedure for some pharmaceutical companies, particularly those with innovative biopharmaceuticals. First a …
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Predicting Progress in Protein Aggregation
As a result, there is increasingly regulatory pressure for biopharmaceutical manufacturers to reduce the risk of immunogenicity by not only controlling, but also preventing, aggregate formation.
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Drugs, At What Cost?
…f, and varying medical and regulatory practices worldwide continue to shape the financial outlook of biopharmaceutical companies.
In a new report, The Global Use of Medicines: Outlook through …
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Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
With the aim of helping to stimulate the global development of these medicines, the EU has opted for more flexibility in the choice of the original biopharmaceutical or reference product to which biop…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Historically, in biopharmaceutical development, criticality has been a frequently arbitrary categorization between important high-risk attributes or parameters and those that carry little or no risk. …
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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…