When considering a CDMO partner keep in mind your future needs.
A graphic representation of the FDA’s Emergency Use Authorization Process.
Instituting good documentation policies early on when developing your biologic drug product can save time and distress when putting together your regulatory submissions.
Analytical Methods should not be the gatekeeper to getting your product to market. Avoiding common pitfalls in development can prevent this.
Regenerative medicine products have unique sensitivities when it comes to regulatory compliance in terms of donor eligibility and Good Tissue Practices
An illustration of the types of vaccines in development for COVID-19
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.
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 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.