Search results for "regulatory" in Articles / App Notes
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…
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Process Development: Go Smarter, Go Faster! Available on Demand
Did you miss our virtual symposium? We heard from leaders at GlaxoSmithKline, Byondis, UCB, UCL, GoSilico, and Cytiva on how they balance innovation, speed, and robustness to accelerate their p…
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Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
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Accelerating an Orphan Therapy to Market
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This case study shares the work of Cytiva’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.…
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Diamyd Medical Selects Cytiva’s FlexFactory Platform to Make Precision Medicine Type-1 Diabetes Vaccine
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Diamyd Medical will install a new Cytiva FlexFactory platform in Umeå, Sweden. Once up and running, the clinical-stage biopharmaceutical company will begin manufactu…
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
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In the current biopharmaceutical landscape, developers are constantly encountering new and diverse biological molecules with complex structures. While these novel biolog…
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mRNA Therapeutics and Vaccines – Key Process Considerations
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Learn more on key considerations and strategies for process development and scaling up in our new web hub for mRNA therapeutics and vaccines.
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
One way to help advance the understanding of new technologies is for instrument vendors to get their new technologies into the hands of the academic, industry, and regulatory science investigators to …
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Process Development: 2020 Reflections and 2021 Possibilities
The challenges posed by the COVID-19 pandemic in 2020 brought about many unprecedented lessons and promising developments in the biopharmaceutical industry. Last year in particular reenforced the ne…
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Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can e…