Search results for "regulatory"
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…hysical sampling of powder raw materials requires rapid material usage post-sampling to comply with regulatory guidance.
The physical properties of powders require extensive cleani…
Article
Can Vaccine Development Be Safely Accelerated?
…ing 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 RNA…
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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In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…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.
Sign up to access and to view an on-demand recording.