Search results for " guidelines" in Articles / App Notes

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…

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…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

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