The Art of the Analytical Method
Emily Sudhyadhom, Senior Analytical Chemist
Analytical Methods should not be the gatekeeper to getting your product to market. Avoiding common pitfalls in development can prevent this.
Important Factors in Regulatory Compliance for Regenerative Medicine Products
Caitlin Bancroft, Senior Regulatory Affairs Specialist
Regenerative medicine products have unique sensitivities when it comes to regulatory compliance in terms of donor eligibility and Good Tissue Practices
COVID-19 Vaccine Fact Sheet
Adam Lambert, Vice President, Product & Process Development
An illustration of the types of vaccines in development for COVID-19
COVID-19 Vaccine Critical Process Operations and Key Quality Attributes
Adam Lambert, Vice President, Product & Process Development
The scientifc community is working to address the need for safe and effective vaccines and treatments, Adam Lambert and our product and process development team share critical process operations and key quality attributes for a COVID-19 vaccine.
Validation of Analytical Procedures: Part 2
Emily Sudhyadhom, Senior Analytical Chemist
Each part has an objective. Part I lays out how to begin to determine the type of analytical procedure based on the intended purpose. Once the analytical category or method type is assessed, Part II lays out the recommended parameters and its relevance to the method validation process.
Validation of Analytical Procedures: Part 1
Emily Sudhyadhom, Senior Analytical Chemist
Validation of analytical methods can often be a daunting task. ICH Q2 (R1) may provide a detailed regulatory direction and framework, but sometimes those details bring about even more questions.
A Guide to Analytical Method Development: Part 2
Emily Sudhyadhom, Senior Analytical Chemist
Part 1 of the guide to analytical method development unraveled the steps and questions in development. Part 2 speaks to the qualification or pre-validation phase in analytical method development.
A Guide to Analytical Method Development: Part 1
Emily Sudhyadhom, Senior Analytical Chemist
An analytical method development guide to assist you in your analytical journey to provide the basic questions to ask, determine the purpose, and provide a starting point.
Preparing For Remote Agency Inspections
Stephanie Gaulding, Director of Compliance
Remote agency inspections have become a necessity due to COVID-19. These are additional considerations to prepare ahead of for the best possible experience.