Search results for "GMP"
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Addressing the Complex Nature of Downstream Processing with QbD
These risk assessments are influenced by platform data, previous process characterization knowledge, available GMP data, and subject matter expertise. DoE activities are applied where appropriate mode…
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Moving PAT from Concept to Reality
In the near future, Sartorius Stedim Biotech also expects wider spread adoption of analytics in GMP that are already available, such as spectroscopy for metabolite control and bio-capacitance for viab…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Density separation using ultracentrifugation is possible but is challenging at GMP manufacturing scale.
Conclusion
Viral contamination of vaccines, albeit rare, can lead to serious human healt…
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Automation Trend in Fill/Finish Reduces Contamination Risk
In May 2017, the company completed an expansion of its aseptic fill/finish operations at its GMP biomanufacturing facility in Rockville, MD, where it installed a new, fully automated vial-filling syst…
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Biopharma Says It Has an Evolution in New Technologies and Processes
A recurring theme was the need for new technologies to accelerate bioprocessing operations and to smooth scale-up from development to GMP processing.
Exhibitors announced new chromatography system…
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FDA Framework Spurs Advanced Therapies
Lonza also expects to see further convergence of manufacturing technologies across therapeutic fields and more defined ‘gold standards’ through, for example, ‘GMP-in-a-box’ systems and the ability to …
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Contract Manufacturing Through the Years
API and GMP intermediate manufacturing during this time was just a piece of the fine-chemical industry, alongside agrichemicals, food ingredients, and various specialized applications. The generic API…
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Unifying Continuous Biomanufacturing Operations
Integrated continuous bioprocessing is already regularly being achieved in small research labs, according to Bonham-Carter, but has not yet made its mark in commercial, cGMP environments (8).
Pr…
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Being Thorough When Transferring Technology
Lonza: A mammalian process designed with insufficient appreciation of operability within a cGMP facility and lack of process understanding from the process transferring partner can increase the risk o…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
…ntibody production facility that can fit into a single cabinet in approximately 20 square feet of a GMP production facility. In a concept described by Jacquemart et al. (2), one cycle of downstream p…