Search results for " GMP" in Articles / App Notes

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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 …

Article Single-use Bioreactors Have Reached the Big Time
She does note, however, that the state of single-use sensor technology for use with single-use bioreactors in GMP biomanufacturing is constantly improving. “There are several approved biologic manufac…

Article Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
…ment purposes (pre-clinical), clinical trials, or commercial scale, as this will define the relevant GMP requirements. Also, if producing at commercial scale, which regulatory standard is needed? Is …

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