Scale-Up And BLA Planning For Microbial Biomanufacturing: When Should You Talk To A CDMO?

Source: Lonza

Over the last decade, emerging biopharma has been a driving force in innovation and development across the life sciences sector, transforming the industry’s R&D model and reshaping the competitive landscape. However, effectively developing and commercializing biotherapeutics often requires smaller companies and startups to leverage knowledgeable partners that have successfully brought other products to market.

In addition, an increased focus on smaller next-generation biologics, such as antibody mimetics and plasmid DNA, is shifting interest back toward microbial biomanufacture as an effective manufacturing platform.

Ensuring early planning of scale-up and biological license application (BLA) activities for your microbial-based product can maximize your chances of success by allowing sufficient time to develop options for launch, ultimately preventing costly delays and setbacks.

Read the complete article to understand how to make a detailed plan at the beginning with the end in mind.


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