Search results for "regulatory"
Article
Best Practices for Data Integrity
In regulatory jargon, this means you want your computerized system to be ‘open’.
In addition, validate. Auditors won’t believe the system behaves as expected when you use it unless you …
Article
Fusion Proteins Pose Manufacturability Challenges
Early in 2017, for instance, Celgene acquired Delinia, which is developing DEL106, a novel IL-2 mutein Fc fusion protein designed to upregulate regulatory T cells (Tregs). Roche/Genentech is focused o…
Article
Being Thorough When Transferring Technology
The technology transfer procedures implemented are typically guided by International Council for Harmonization (ICH) Q10 or equivalent guidance from other regulatory authorities. This guidance is prac…
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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
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
In-vivo testing may also be required, depending on regulatory concerns. Comparative analysis through clinical evaluation is also required for production of the biosimilar product.
Immunogenicity i…
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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…
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Improving Process-Scale Chromatography
“Although this process has been used at industrial scale for other markets, the biopharmaceutical sector has struggled to implement the technology for a variety of regulatory reasons and due to its co…
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Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
Establishing Acceptance Criteria for Analytical Methods
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Direction from guidance documents
What do regulatory and standards organizations say about acceptance criteria for analytical methods? The following are brief quotes from the guidance docum…
Article
Managing Biomanufacturing Capacity Expectations
…a drug, a change in raw material availability, availability of new therapeutic alternatives, or new regulatory legislation.
In a Nature Reviews Drug Discovery study from 2013, investigators concl…