Search results for " qualification"
Article
Using Digital Twins to Model Process Chromatography
To allow for a prediction of the complete process on a new scale, only the basic fluid dynamic properties need to be known that can be derived from, for example, column qualification runs.
BioPhar…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Critical quality attribute identification/assay development: Identify and develop assays for critical quality attributes, potency assays—overestimate testing needs!
Methods/equipment qualific…
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Supply Chain Challenges for Single-Use Systems
The volume, complexity, and cost of qualifications can be burdensome for both the single-use supplier and the end-user. With new requirements for extractables and other testing, the time associated wi…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Regulatory guidelines exist for the selection, qualification, and testing of these raw materials and indicate that not only known, but also emerging viruses should be sought (12–16). There are also sp…
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Understanding Validation and Technical Transfer, Part I
It is not following by rote a series of “qualifications” such as design (DQ), installation (IQ), operational (OQ), and performance qualification (PQ) studies. It is not hiring a validation company to …
Article
Modern Manufacturing Key to More Effective Vaccines
…tial for process change during technology transfer, scale-up difficulties, and a need for additional qualification lots. Similarly, Cristiana Campa of GSK Vaccines in Italy emphasized that the comple…
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Ensuring Sterility in Small-Scale Production
These factors include assuring appropriate use of disinfectants before, during, and after manufacturing; proper gowning and aseptic technique of the operators; and making sure the environmental and qu…
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Advancing Single-Use Technology Through Collaboration
…chnology in terms of the potential risk to quality, as well as a lack of clear understanding of full qualification and validation requirements,” and documents such as this testing protocol aim to rem…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
The elements of the safety triangle include the selection of source materials and release based on prior material and supplier quality approval and qualification testing for adventitious contaminants;…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
To be successful, however, the lead partner will need an understanding of biomanufacturing facility design, engineering, qualification, and validation, as well as the operational aspects of combining …