Search results for " drug"
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Improving PAT for Biologics
Because bioprocesses are complex and dependent on multi-factor interactions between the process variables, using PAT for biotherapeutics can be more challenging than for small-molecule drug manufactur…
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Analyzing Proteins Using SEC, MALS, and UHPLC
“Understanding the aggregate content is important because aggregates not only consume monomers and thus reduce the efficiency of the drug, they also are believed to cause immune responses. Thus, even …
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Gowning Practices Provide Clues to cGMP Compliance
Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the gl…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished produ…
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Climate Change in Outsourcing
Industry changes
The expiration of patents on blockbuster drugs (i.e., the “patent cliff”) remains the predominant event reshaping the bio/pharmaceutical industry. Despite years of advance warning…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1). QTPP is defined in ICH Q8 (R2) as "a prospective …
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Flexibility in Biopharmaceutical Manufacturing
The history of bioprocessing drug substances has been such that mono-facilities were built to produce large volumes of single blockbuster products. The business environment has changed and biofaciliti…
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Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…
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Reviewing the Importance of Biosimilarity and Interchangeability
Establishing biosimilar analytical studies
There are several key criteria to consider when establishing analytical studies for a biosimilar drug candidate to ensure its safety, efficacy, and similar…
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Top Tips for Successful Development of Antibody Chromatography Processes
We've seen this specific drug class continue to reshape medicine, right? It's so amazing what we've learned about these molecules, their potential, the different ways to leverage these proteins. I'm r…