Search results for " biopharma"
Article
Use of Multivariate Data Analysis in Bioprocessing
The biopharmaceutical industry, however, has accrued greater benefits as evidenced by publications highlighting the use of MVDA tools both in upstream as well as downstream processes (9). This is in p…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Particle-detection methods
There are various detection technologies that should be used to address protein aggregation needs at various phases of the biopharmaceutical development process; however…
Article
FDA Approves First Biosimilar
She said that some biopharma companies fail to establish a strong foundation of analytical data to ensure sufficient similarity, and may have to redo pharmacology studies and other trials as a result.…
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Improving PAT for Biologics
Advances in high-throughput systems, Raman and near-infrared (NIR) spectroscopy, high-performance single-use sensors, and chemometric methods are also helping manufacturers of biopharmaceuticals overc…
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QbD and PAT in Upstream and Downstream Processing
Girard (Spinnovation): The underlying concept for QbD of an upstream bioprocess is that the desired quality of the biological or biopharmaceutical product is assured every time. CQAs vary for each cel…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
While there is agreement on the value of process and product understanding, there is often debate within most biopharmaceutical companies on the extent of QbD investment and underlying cost implicatio…