Search results for "quality" in Articles / App Notes
Article
Continued Process Verification for Biopharma Manufacturing
What is Continued Process Verification?
CPV is fundamentally a formal means by which the performance of a commercial manufacturing process is monitored to ensure consistently acceptable product qu…
Article
Reimagining Affordable Biosimilars
For biosimilars, factors that significantly impact affordability and development time include: development cost, variability in product quality, and low success rates of trials.
Cost of biosimil…
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Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…
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Managing Risk in Raw Material Sourcing
IPEC has developed standardized templates and materials to help simplify supplier evaluation and auditing, as well as the development of quality agreements, and to ensure consistency. Having additiona…
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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…
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Taking a “Development-by-Design” Approach to Cell Therapies
The goal is to provide high quality and sustainability,” he says. Removing manual operations and human error from the process will be crucial.
Invetech has been working on cell therapy process sca…
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Continuous Manufacturing: A Changing Processing Paradigm
Other advantages of continuous manufacturing include consistent product quality; smaller equipment; streamlined processes; low process cycle times; reduced operating costs; increased flexibility; elim…
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Digitalization: The Route to Biopharma 4.0
It is evident that there is an urgent need to incorporate digital solutions at initial stages of process development, manufacturing, and quality assurance (QA).
Digitalization in pr…
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Eliminating Residual Impurities Starts with a Strategic Plan
A risk-based approach to identifying potential residual impurities is important for understanding any risks to the product quality and potentially the patient. It also allows the development of an opt…
Article
Improving Upstream Predictability
“Using automation, process analytical technologies (PAT), and advanced multivariate analysis has enabled the industry to control process performance and product quality more closely than ever before,”…