Search results for " meeting"
Article
Global Expansion Shapes Drug Oversight
At the annual meeting of the Food and Drug Law Institute (FDLI) in April 2014, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace…
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Good Manufacturing Practices: Challenges with Compliance
The challenges lie in how a sponsor’s approach may be interpreted by FDA in meeting the GMP regulations for some biologic products and/or in specific scenarios where advanced manufacturing (i.e., new …
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Could you share your viewpoint on the importance of this meeting?
The Recovery of Biological Products is probably the meeting most relevant to scientists, engineers, and managers in the bioprocess…
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Modular Manufacturing Platforms for Biologics
According to Michael O’Brien, vice-president of Pfizer Pharmaceutical Sciences Technology & Innovation Group, who spoke about the units at the 2015 Parenteral Drug Association Annual (PDA) Meeting on …
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FDA Approves First Biosimilar
It was implied by speakers at the March 6 meeting that switching from one drug to another may be the focus of the forthcoming draft guidance on interchangeability. The formation of drug-specific antib…
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Quality by Design—Bridging the Gap between Concept and Implementation
One of the speakers at the meeting, Christine Moore, acting director of FDA’s Office of New Drug Quality Assessment (ONDQA), summarized the main concerns as being the classifying of criticality, level…
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Quality by design for biotechnology products—part 1
Developing the Design Space Bioprocess manufacturing can be conceptualized as a series of contiguous unit operations such that meeting the drug substance or drug product quality targets is an end resu…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
“At this point, manufacturers are meeting requirements for 2D barcodes on packaging, and including package identifiers, National Drug Code (NDC) code embedded into the GS1 Global Trade Item Number (GT…
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The Challenge of Disruptive Technologies in Bioprocessing
Disruptive innovations
“Keeping in mind the trends mentioned, there is a focus to improve productivity and have platformable processes for these new modalities, while meeting the high quality and …
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Understanding Validation and Technical Transfer, Part I
…hich provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes” (5).
In 2000, ICH Q7A def…