Search results for "risk analysis"
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
By Rebecca Strawn
Sergey/stock.adobe.com
Almost all drug product…
Article
Essentials in Quality Risk Management
Risk assessment includes risk identification, risk analysis, and evaluation. This process is generally a team effort to work through the product/process step-by-step to identify and evaluate each pote…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This article presents the first part of a practical roadmap that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process valid…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
It should be conducted using a risk analysis tool suitable for viral risk (e.g., failure mode and effect analysis [FMEA], preliminary hazard analysis [PHA], and risk ranking and filtering [RRF]) with …
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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
Evaluating E&L Studies for Single-Use Systems
The risk analysis of each product contact material used in the process takes into account variables including:
• Proximity to the API/drug substance and final drug product
• Extraction capabil…