Search results for " attribute" in Articles / App Notes
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…
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…
Article
Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
Article
Modular Manufacturing Platforms for Biologics
…m processing structures can be deployed and redeployed rapidly without compromising required quality attributes.”
Cleanroom pods can be used for entire process streams, as in the Caliber example,…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Such standards will aim to capture critical product attributes that can indicate quality problems, needed corrective actions, and justify enforcement decisions. OPQ’s Office of Policy for Pharmaceutic…