Search results for " system"
Article
GMP Challenges for Advanced Therapy Medicinal Products
In particular, they often do not have adequate systems in place for evaluating the quality of starting and raw materials, which is a vital necessity in the production of advanced, usually biological, …
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
The sample readout from an SPR system such as Biacore (Cytiva) is related to molecular mass and any binding event can be detected without the use of labels (Figure 2). The readout is continuous, which…
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Viral Clearance Challenges in Bioprocessing
One major concern for biologics production is the entry of a small, non-enveloped, chemically resistant virus into the manufacturing system, according to Zhou. “Good facility design and strict complia…
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Pharma Investments Reflect Key Industry Trends
Increasing access to single-use technologies for biologics production is further enabling the scale-down of manufacturing facilities, because such systems provide flexibility and enable companies to q…
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Applying GMPs to the BioPharma Supply Chain
Suppliers need to have a system for assuring the quality of their products in line with GMPs or an appropriate fit-for-purpose classification approach. Suppliers at all tier levels should similarly re…
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Analyzing Proteins Using SEC, MALS, and UHPLC
“Improvements in high-performance liquid chromatography (HPLC)/UHPLC design with respect to system dispersion and sensitivity and advances in particle technology will further improve chromatographic p…
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Gowning Practices Provide Clues to cGMP Compliance
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMPs). Quality must be built into the design of a facility to ensure that drugs are manuf…
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Quality by Design—Bridging the Gap between Concept and Implementation
…(ICH) covering pharmaceutical development (Q8), quality risk management (Q9), pharmaceutical quality systems (Q10), and the development and manufacture of drug substances (Q11) (1-4).
The in…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Sources of information from other quality and manufacturing systems such as change control; scheduled preventive maintenance, calibration, or production interruptions; and customer complaints should b…
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Evolution of the Monoclonal Antibody Purification Platform
Table I summarizes some of the process development challenges with mAb quality from the various expression systems and the tools and unit operations options for addressing these challenges.
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