Search results for " data integrity"
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
By Feliza Miraso…
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
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
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Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Specific components of a good plant management system include electronic batch record capability, role-based recipe management that optimizes each stage of a recipe lifecycle, data integrity features …
Article
Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
Article
Automating Processes in Upstream Processing
BioPharm: How do data collection and data integrity factor into process controls?
Marshall: This is a very important area associated with process control systems, and the collection and the protec…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…