When Is A New Biologic Ready For GMP Production?

With the growing promise of cell and gene therapies and mRNA vaccines, an increasing number of companies both large and small are racing toward clinical trials on their way to commercial success. However, many small biotech companies do not have the facilities, capabilities, or the expertise for good manufacturing practices (GMP) manufacturing of their biological components. To further complicate matters, the Food and Drug Administration (FDA) has published about 30 guidance documents focused on gene and cell therapies related to chemistry, manufacturing, and controls.¹ The European Medicines Agency has an even longer list.²

Such stringent criteria present significant barriers for entry into DNA, RNA, and protein GMP production. Through years or even decades of navigating these conditions, however, an experienced contract development and manufacturing company (CDMO) can bring invaluable knowledge to the production process. A good partner can help keep a project moving forward by sharing best practices and working with their clients on a discovery phase, setting them up for success in their transition from research-use only (RUO) materials to materials manufactured under GMP guidelines.

The first step in finding the right partner CDMO is aligning on goals and expectations. Clients with new biologics can streamline this experience by first anticipating several questions that potential manufacturers will ask about their product before production can even begin. While there are differences by modality in DNA, RNA, and protein, this report will make general recommendations on questions to prepare for and suggest steps that companies should consider when preparing to move to clinic.