Search results for " analytical"
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Biosimilars to Drive Modern Manufacturing Approaches
FDA officials are emphasizing how advanced analytical methods can document product performance similar to a reference drug, and that cutting-edge technology can ensure reliable production of high-qual…
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Digitalization: The Route to Biopharma 4.0
By transforming data into an intelligence-supporting decision-making tool, it is easy to realize the longstanding regulatory initiatives of process analytical technology (PAT) and quality by design (Q…
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Optimizing your Cell Culture Process to Improve Productivity
Alicia Elwood: Cell culture analytical testing allows us to observe what is happening with the cells in culture at a molecular level. Analytical testing provides quantitative data that can be used for…
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Assessing Manufacturing Process Robustness
Documents and methods
Based on the 2011 FDA process validation guidance and relevant ICH guidances, this assessment method requires the use of analytical and interpretive methods based on stan…
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Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
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Biopharma Advances Demand Specialized Expertise
…, executive director, PPD Consulting; Rekha Patel, global director, large molecules, development and analytical solutions, Catalent Pharma Solutions; and Mark Rogers, vice-president, SGS Life Science…
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Eliminating Residual Impurities Starts with a Strategic Plan
Monitoring the efficiency of the residual impurities will be guaranteed through the development of robust analytical methods,” he explains. Savoy also recommends that methods be developed following an…
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Preclinical Evaluation of Product Related Impurities and Variants
For this class of products, the fundamental paradigm is to rely on analytical comparability to the highest possible level without the need of furnishing extensive clinical trial data (7). This, howeve…
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Being Thorough When Transferring Technology
Lonza: The unique characteristics of an antibody-drug conjugate--a small-molecule cytotoxic moiety attached by chemical linker to an antibody--demand unique manufacturing and analytical infrastructure…
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Essentials in Quality Risk Management
…phase during drug development and manufacturing and changes in drug-product formulation, definition, analytical method, and associated process changes are understood and managed to ensure patient saf…