Search results for " analyze" in Articles / App Notes
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Challenges in Analytical Method Development and Validation
The new FDA draft guidance recommends that forced degradation samples or samples containing pertinent product-related impurities should be analyzed at both labs for a stability indicating method. For …
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Outsourcing and offshoring are some of the many key areas analyzed. Over the past decade, BioPlan has found that developing regions, including China, India, and Brazil, as well as the substantial inve…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
Government agencies are funding cost-effectiveness studies; payers and large providers are investing in health technology assessments and forming alliances to analyze real world data; and most informa…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Applying a cause-and-effect matrix approach, the potential impact of each unit operation on the final product CQAs was assessed and each unit operation was thoroughly analyzed for its directly control…
Article
Best Practices in Adopting Single-Use Systems
Bioprocessors must first analyze benefits and risks for their specific situation, keeping in mind their expression system, process, product, and corporate objectives.
After determining the suitabil…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
With the knowledge of which unit operations have impact on particular CQAs, it is now possible to analyze each process’ inputs and outputs to determine how process parameters affect the CQAs.
Inpu…
Article
Essentials in Establishing and Using Design Space
Data analysis and transfer function generation
A multivariate analysis software application needs to be used to analyze the data, eliminate any outliers, determine statistically significant fa…