Considerations for CDMO Selection

Barrett Fallentine, Director, Product & Process Development

When considering a CDMO partner keep in mind your future needs.


Navigating the FDA’s Emergency Use Authorization Process

Bikash Chatterjee, Chief Executive Officer

A graphic representation of the FDA’s Emergency Use Authorization Process.


Best Practices for Creating Submission Ready Documents

Barrett Fallentine, Director, Product and Process Development

Instituting good documentation policies early on when developing your biologic drug product can save time and distress when putting together your regulatory submissions.


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.