Search results for " meeting" in Articles / App Notes
Article
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…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…
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A deep dive into optimizing AAV capture and polishing to maximize both yield and purity
As demand for AAV vectors grows, so does the need for scalable and cost-efficient purification processes. It’s critical to maximize both overall yield and removal of impurities, including empt…
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Report from the 6th International HTPD Conference
…er the course of the four-day conference, and the discussions and exchange of information during the meeting was both open and intense.
The HTPD conference series started as a joint…