Search results for " control"
Article
Addressing the Complex Nature of Downstream Processing with QbD
Specifications for the drug substance, excipients, and drug product and controls for each manufacturing step are determined through a control strategy. The final elements of QbD are process capability…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ment and utilities
Outside plant environment
• Specific virus controls in the product manufacturing process:
Virus testing (bulk harvest, drug substance, dru…
Article
Quality by Design and Extractable and Leachable Testing
Confirmation that the supplier has cGMP control over its manufacturing process is essential. Once variability is known, one can assess the impact of this variability on component leachables, and in tu…
Article
Essentials in Establishing and Using Design Space
Product and process control applications
Based on the equations, selection of the control strategy can take place. Process controls can be one of the following: feed-forward, feedback, in-situ…
Article
PDA's Technical Report for Biotech Cleaning Validation
The report uses a life-cycle approach to biotechnology cleaning validation that encompasses design and development, process qualification, and ongoing control of effectiveness. It also considers the r…
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.
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Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Coherent policies and procedures should describe precisely how the careful control of facilities, equipment, and materials will be used to prevent unacceptable exposure to animal-sourced materials. Us…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Provided is a comprehensive, risk-based transgene characterization strategy; its implementation is based on chemistry, manufacturing, and control (CMC) development phases to ensure that the integrity …
Article
Applying GMPs to the BioPharma Supply Chain
At an operational level, it is vital that biopharmaceutical production is carefully controlled within defined parameters and there is no possibility of contamination. Suppliers share a commensurate re…
Article
FDA Seeks Metrics to Define Drug Quality
Most obvious are reports of company recalls, poor inspection outcomes, and adverse events that are visible to FDA and can indicate broader deficiencies in manufacturing process and control strategy.
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