Search results for " Quality control" in Articles / App Notes
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
A Look into the Future of Biopharmaceutical Quality
Quality Control Unit Advancements
BioPharm: How do you see the role of the quality control (QC) unit changing in the coming years?
Newcombe (PAREXEL): I would not anticipate any significant…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Apheresis center capacity, donor network access, sample handling expertise, and quality control systems all contribute to the ability to achieve reproducible starting material quality and efficacy.
…
Article
Moving PAT from Concept to Reality
“PAT is bringing quality control testing closer to the manufacturing floor for on-time/real-time release and development of predictive models to enable active process control and reduce batch rejectio…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
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
Improving PAT for Biologics
Chemometrics
The continuous real-time quality control and assurance that is highly desired in biopharmaceutical manufacturing can be achieved using sophisticated process control strategies based o…
Article
Using Software in Process Validation
Software systems have become instrumental as validation expands from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, l…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…