Search results for " GMP"
Article
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…
Article
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
This GMP-in-a-box system aims to deliver on scalability and cost-of-goods reduction, and to provide a robust solution for personalized therapies such as CAR-T often requiring small-scale manufacturing…
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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
…extractables and leachables was conducted; this analysis would typically be a necessary step for the GMP production of biologics. However, there are vendors that are now investigating column sterilit…
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Being Thorough When Transferring Technology
…non-cGMP conditions will allow [them] the flexibility to make the appropriate adjustments for future GMP lots.
References
1. R. Beall and W. Rushing, “Effective Technology Transfer Strategi…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
…antibody 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 …