Cambrex Expands Peptide Manufacturing Capabilities in US

The new GMP manufacturing suite increases the overall facility footprint by 20% and includes an ISO-7 cleanroom for preparative HPLC chromatography and lyophilization, cold storage for raw materials and a product storage suite. With the completion of this investment, Snapdragon can now support peptide projects from development to GMP manufacturing using solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS), or hybrid approaches.

“We designed this facility with a three-step strategy in mind for the development of peptide drug candidates,” said Eric Fang, General Manager at Snapdragon Chemistry. “We start with automated SPPS technology for proof-of-concept. In parallel, we optimize the process using LPPS synthesized technology to accelerate development and reduce manufacturing cost. We can then transfer the process to our large manufacturing facilities, such as Charles City, Iowa, to produce materials in traditional large batch reactors, significantly reducing the cost of those drugs.”

Snapdragon’s LPPS technology utilizes traditional API batch reactors and continuous flow, obviating the dependency on specialized, solid-phase reactors. This new LPPS technology materially reduces solvent demand and the need for excess reagents compared to standard solid-state peptide synthesis processes.

“SPPS certainly has its place. We use it in early development to get to the clinic and to proof-of-concept quickly, but it’s not a scalable solution if you want to supply a huge patient population,” said Matt Bio, Chief Scientific Officer, Cambrex. “We designed the LPPS process so that we can leverage all 1.4 million Liters of capacity within Cambrex to deliver peptide therapies.”

Cambrex continues to invest in R&D across complex synthetic modalities, including further innovation for peptide manufacturing, as well as new research on the application of artificial intelligence for the optimization of oligonucleotide processes.