Search results for " regulatory" in Articles / App Notes
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
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…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
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…
Article
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 conc…
Article
Make buffer preparation more time and cost efficient with inline conditioning
Simplify Buffer Preparation
The volume and number of buffers for a typical downstream process can be considerable.
Preparation of these buffers is a challenge that in-line conditioning can o…
Article
Vaccine Development Faces Urgency and Challenges
Experts seek to improve public health infrastructure and to reach global agreement on clinical trial design and regulatory decision making to support rapid development of needed therapies. At a Minist…
Article
Lessons Learned Accelerate Vaccine Development
Two specific examples that benefited Janssen included the collaborative approach that was taken to gaining regulatory approvals and a new structure for the production and facility refurbishment teams.…