Search results for " qualification"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Automating the Biomanufacturing Process
…omatically during the production process, which could significantly reduce the time needed for final qualification steps and product release. “RTR entails higher up-front cost for the equipment and s…
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Using Multiple Techniques in Biosimilar Analysis
While a full method qualification of specific quality attributes requires much more statistical rigor, this preliminary case study demonstrates that exploring a broader landscape may add valuable comp…
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Scaling Up Novel Therapies
They also allow manufacturers to leverage performance data across multiple products, reducing the cost of late-stage process characterization and qualification. In addition, they permit some degree of…
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A Plastic Pipeline for Commercial Bioprocessing?
In January 2018, Fujifilm announced the qualification of its Saturn mAb Solutions facility in College Station, TX for cGMP production of monoclonal antibodies. The building was designed to accommodate…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
At the CASSS symposium, Samantha Maragh of NIST provided an update on collaborative efforts to develop measurement standards for genome editing, including an assay qualification process that would exp…
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Leveraging Data for Better Biopharmaceutical Process Control
This approach would result in very fast process/product understanding, but more importantly, would support the process performance qualification (PPQ, Stage 2) and the entire commercial lifecycle (Sta…
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Applying GMPs in Stages of Development
…you will want to qualify your supplier and establish a quality agreement in addition to the material qualification.
Although not all GMP requirements apply to products in the early stage…
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Navigating Data Integrity in the Modern Lab
It is also of the utmost importance that users are appropriately trained on the systems, and that their qualifications kept up-to-date.
Article
Transformative Medicines Challenge FDA and Manufacturers
And process scale-up further requires identification and qualification of thresholds and specifications.
Combos crucial
The process of developing and delivering cutting-edge gene therapies a…