Search results for " control"

Article 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…

Article 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Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…

Article 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…

Article 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…

Article 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…

Article 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…

Article Challenges of Protein Aggregation During Purification
If not controlled, however, Vedantham notes that these operations may also lead to an increase in aggregates, typically due to protein unfolding while the protein is adsorbed on the stationary phase. …

Article Design of Experiments for Analytical Method Development and Validation
• Identify the error control plan and run the study. • Analyze the study and determine settings and processing conditions that improve method precision and minimize bias errors. Document the desig…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
A product developed using QbD principles will rely on manufacturing controls based on what is known to be crucial to the process. The PCS package results in a well-defined process with criticality und…

Article Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
A fit-for-purpose facility design leveraging state-of-the-art technologies such as centralized building sensors, monitoring, and control for greater connectivity and single-pass-through air, meanwhile…

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