Search results for " attribute"
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
Article
Perfusion in the 21st Century
In addition, the shorter retention times and more consistent conditions achieved at steady state provide more homogeneous product quality attributes (6).
Because of higher volumetric productivitie…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Conclusions
Viral safety is an important quality attribute of a drug product. Endogenous or adventitious viral agents are generally regarded as product impurities and are not acceptabl…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
By mapping skills against requirements, it is possible to identify key attributes external partners need to have to make a project a success, first time.
About the authors
Peter Genest is glob…
Article
Vaccine Development Faces Urgency and Challenges
The extensive process was needed to document unchanged quality attributes of the adjuvant under a new automated quality control system.
Similarly, Wilson Forsyth, director of quality control at As…
Poster
Modes of controlling charge variant distribution in Mab production
Charge variant distribution is a critical quality attribute for MAbs and is therefore of interest to monitor and control during the production process. In this study, we investigated the effects of ce…
Article
Biopharma in 2015: A Year for Approvals and Innovations
…tion equipment
A Bright Future for the Plasma Fractionation Industry
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
References
1. 2015 New Drug Approv…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Another area to which more CMOs attribute internal performance improvements is upstream production operations. In the 2015 survey, 64% of respondents said that these improvements contributed to better…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
For example, it can be challenging to score and rank meaningfully the critical quality attributes (CQA) when developing a control strategy. Most often, there is not much patient data from the clinical…
Article
Biopharma Advances Demand Specialized Expertise
In part, this may be attributed to the ‘kit’ and ‘black box’ approach of many modern day technologies. Due to the complexity of many biopharmaceuticals, their development and success as therapeutics r…