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…
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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…
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…
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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 …
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…
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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 …