Search results for " sterile"
Article
Technologies and Practices Must Evolve to Meet Demand
Sampling systems, single-use systems, and sterile sampling received “poor” or “inadequate” grades from more than 19% of the respondents.
Survey participants also rated how the level of inno…
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Manufacturers Struggle with Breakthrough Drug Development
FDA will want to know how the company will validate manufacturing processes for drug substances and products, will ensure microbial control for sterile drugs, and will handle changes in formulation an…
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Best Practices in Adopting Single-Use Systems
For example, if commercial production relies on sterile welders and sealers, users should specify compatible tubing that meets material requirements.
Proprietary components not generally available …
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
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.
A…
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FDA Seeks Metrics to Define Drug Quality
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern about drug quality and safety. Despite a decade of encouragement and guidance from FDA, manuf…
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
As you may already know, many biopharmaceutical manufacturers are producing drugs at higher concentrations. This trend is mainly driven by the demand for subcutaneous drugs that are self-admin…
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High-concentration monoclonal antibody drugs: manufacturing challenges
Manufacturing unit operations that are directly impacted by higher concentration formulations range from ultrafiltration to sterile filtration, filling, mixing and storage. Solutions that maintain qua…
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Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
In a validated GMP process, filters must be routinely tested for integrity. The automated test instruments that are used for filter integrity testing have been improved over the past 40 years. …
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Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
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Good Manufacturing Practices: Challenges with Compliance
There is an underlying assumption in regulations that most biologics are destined for simple filtration and sterile fill, with little attention given to non-traditional, more complex dosage forms.
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