Search results for " regulatory" in Articles / App Notes
Article
Can Vaccine Development Be Safely Accelerated?
…ding access to not only its vaccine expertise, but also its relationship and experience with Chinese regulatory authorities and clinical trial management in the country.
Prophylactic messenger RN…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
This provides the benefit of regulatory compliance and assured quality from the outset, while also avoiding the need to transport collected apheresis products to an off-site facility for preliminary c…
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Biosimilar Quality Requirements
By Feliza Mirasol
Recent guidelines released by FDA emphasize the agency’s efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to h…
Article
Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
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Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Use of high-throughput methodologies
This toolset can help you overcome some of the challenges with time limitations, a diversified pipeline, and more regulatory demands for more comprehensive d…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol
With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …
Article
Faster Flavivirus Vaccine Production
This is valuable both for regulatory compliance and future drug development.
Read the article and access the white paper here
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
He also covered the latest regulatory strategies and a new assay validation guideline for surface plasmon resonance (SPR) technology.
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Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Additional benefits will be providing a way to upskill the workforce and to focus on regulatory concerns, such as model validation and change management. Results and the white paper are due to be rele…
Article
Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…