Search results for "Mabs"
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
Article
Quality by design for biotechnology products—part 1
Understanding the structure and functional attributes of therapeutic proteins, including monoclonal antibodies (MAbs), is key to developing the design space, because that understanding facilitates the…