Search results for "biopharm"
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Q&A with Industry Leaders: Rita Peters
With additional product lines through acquisition or innovation, many suppliers emphasized capabilities of providing end-to-end technologies, equipment and support to the biopharmaceutical manufacturi…
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Manufacturers Struggle with Breakthrough Drug Development
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs” that offer exceptional promise in treating patients with serious medical needs. Such designa…
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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?
…, 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 2…
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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…