Search results for " meeting"
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…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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Navigating Emerging Markets: Middle East and North Africa
The lobbying group does note that it is encouraged by the Minister of Health’s announcement at a PhRMA meeting that the government would reduce the review time required for marketing authorization and…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
AAPS Annual Meeting. 2007.
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Regulatory Challenges in the QbD Paradigm
Therefore, meetings are recommended when such strategies are followed. The comparability protocol offers advantages as the submission strategy for new in-process testing methods as well. For example, …
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
They have several other meetings pending. So there’s obviously been a lot of activity behind the scenes, if you will, of companies approaching FDA even before the guidelines were published.”
Levi…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
As you may already know, many biopharmaceutical manufacturers are producing drugs at higher concentrations. This trend is mainly driven by the demand for subcutaneous drugs that are self-admin…