These common terms are often used incorrectly.
What is the impact of the Delta Variant?
A comparison of two types of cell sources. Key considerations for scale up for cell and gene therapy.
Regulations mandate that methods for analysis of drug substance and drug product are stability indicators.
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