Search results for " control" in Articles / App Notes
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Impurity Testing of Biologic Drug Products
Control of these steps must be demonstrated by validation and/or quality control checks on the bulk drug substance. Control of impurities that could arise from the fill/finish process are then assesse…
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Transformative Medicines Challenge FDA and Manufacturers
… risk management, setting specifications, and assuring compliance with chemistry, manufacturing, and control (CMC) standards for experimental treatments. Presentations covered the importance of contr…
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Reducing Cross-Contamination Risks in Process Chromatography
In addition, disposable flow-paths on single-use downstream processing equipment typically come gamma irradiated, leading to better bioburden control, according to Lundström. Preparatory and post-proc…
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Managing Residual Impurities During Downstream Processing
USP monographs and associated reference standards, according to Atouf, can be used to control product variants during the lifecycle of therapeutic peptide and protein products.
“USP continues to de…
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Vaccine Development Faces Urgency and Challenges
The extensive process was needed to document unchanged quality attributes of the adjuvant under a new automated quality control system.
Similarly, Wilson Forsyth, director of quality control at As…
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Aseptic Processing: Keeping it Safe
Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…
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Use of Multivariate Data Analysis in Bioprocessing
Researchers have applied PCA to monitor a bioreactor producing Penicillin acylase in Bacillus by generating online multivariate control charts (10). The dataset contained information exclusively relat…
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Modular Manufacturing Platforms for Biologics
There are numerous benefits related to quality control with building and qualifying units off site. If a full module is unrealistic because of budget or existing architectural constraints, a piecemeal…
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Tackling Analytical Method Development for ADCs
Both small and large
As for any drug, analytical methods for the characterization of ADCs must be developed, and separate quality control (QC) tests must be established for lot release of the fina…
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Setting Standards for Biotech Therapeutics in India
In India, the Drug Controller General of India (DCGI)-led Central Drugs Standards Control Organization (CDSCO) together with the State Authorities are primarily responsible for ensuring the quality of…