Search results for "qbd" in Articles / App Notes
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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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FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
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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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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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Getting Your Investigational Drug Regulatory Ready
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Navigating regulatory requirements can be overwhelming. This article outlines basic strategies for efficient regulatory review and drug approval.
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Planning for IND
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Learn how to navigate regulatory requirements as you progress through clinical trials to commercialization.
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Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…