Search results for " guidelines"
Article
Bioburden Control in the Biopharmaceutical Industry
Great efforts are needed to deliver suitable knowledge, skills, awareness, and training to the working staff through rigorous policies, protocols, guidelines, references, and standard operating proced…
Article
Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
Evaluating E&L Studies for Single-Use Systems
Regulatory guidelines require that the product contact items “shall not be reactive, additive, or absorptive” to assure drug product quality and safety (2). The manufacturer is, therefore, responsible…
Poster
FlexFactory™ Automation
To enable compliance with regulatory requirements, FlexFactory Automation is designed according to GAMP™ 5 guidelines (ISPE).
Article
Real Time Continuous Microbiological Monitoring
…g damaged, stressed, dormant, and VBNC cells) that usually do not grow on the media described in the guidelines but could potentially grow as an opportunistic infection under special conditions found…
Article
Analysis of Glycosylation in Biosimilars
…6B, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products guidelines (1).
Determining glycosylation patterns
Glycosylation pattern analysis is a ste…
Article
Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …
Article
Design and Qualification of Single-Use Systems
EMA, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation, February 2014.
7. BPSA, Component Quality Test Matri…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
With the plethora of regulatory guidelines and associated compliance requirements to adhere to when building a facility, it must be clear whether the product is for research and development purposes (…
Article
Continuous Processing for the Production of Biopharmaceuticals
Both FDA and the European Medicines Agency (EMA) have changed their guidelines to reflect a change in the definition of a batch. Batch is now defined by the quantity of material rather than the mode o…