Search results for " Quality control"
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…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
Article
FDA Seeks Metrics to Define Drug Quality
Documented quality events, overdue regulatory commitments, or an increase in rejected batches may signal the need for action to maintain product quality control.
To assess contract manufacturers, …
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Process speed, tighter quality control, and lower costs achieved by combining highly skilled staff with automated processes provide a competitive advantage for the next generation of biological medici…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…
Article
Supply Chain Challenges for Single-Use Systems
The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to en…