Search results for " risk mitigation"
Article
Addressing the Complex Nature of Downstream Processing with QbD
We have adopted a risk mitigation strategy in response: we no longer buffer flush our nanofilters to recover the remaining product, essentially taking a yield loss on the step to ensure a quality pro…
Article
Ensuring the Biological Integrity of Raw Materials
Archie Lovatt, biosafety scientific director of SGS Vitrology, advocates an active risk mitigation strategy incorporating multiple strategies and approaches for managing contamination risk. “Essential…
Article
Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
By Agnes Shanley
Choosing excipients and supplie…
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
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…