Search results for " specification"
Article
The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This interpretation of CQA is most applicable to in-process and finished-product specification limits, which suggests that these limits must be critical given that they were designed to ensure product…
Article
Essentials in Establishing and Using Design Space
…on) and achieve all critical quality attributes (CQAs), product and process acceptance criteria, and specifications. Knowledge of product or process acceptance criterion (specification limits) is cru…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Comparison to regulatory specifications
As there is no approved cell-based LAIV on the market today, no regulatory requirements in terms of impurities are established. Hence, the output from the s…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
Article
How To Execute Successful Data Migrations
…ocument off-line? Similarly, how far back will a company need to maintain manufacturing logbooks and specifications for retired formulations?
On many levels and for many reasons, the amoun…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
Article
Using Software in Process Validation
to ensure that the finished product meets all quality attributes, including specifications.
Documentation and traceability for compliance
Part of the validation process is in the documentati…
Article
Best Practices for Selecting a Top-Quality Cell Line
This issue is particularly important for biosimilars, because the glycosylation patterns of biosimilars must meet biosimilarity specifications when compared to the innovator drugs, which can only be a…