#USA #Waltham #Cambrex #Snapdragon Chemistry #Peptide Therapies

Cambrex Expands Peptide Manufacturing in Waltham

Cambrex, a prominent global leader in contract development and manufacturing (CDMO), has recently unveiled an expansion of its peptide manufacturing capabilities at its Waltham, Massachusetts facility. This significant enhancement will be executed through its subsidiary, Snapdragon Chemistry, which specializes in the development and production of active pharmaceutical ingredients (APIs).

The new facility expansion introduces a state-of-the-art GMP (Good Manufacturing Practice) manufacturing suite that broadens the operational space by 20%. This suite includes a modern ISO-7 cleanroom dedicated to preparative HPLC chromatography and lyophilization processes, and it features cold storage facilities for both raw materials and finished products. This upgrade will significantly bolster Snapdragon's ability to manage peptide projects from the early development stages right through to large-scale GMP manufacturing.

As Dr. Eric Fang, General Manager of Snapdragon Chemistry, stated, the facility was designed with a three-step strategy aimed at fostering the development of peptide drug candidates. Initially, the use of automated solid-phase peptide synthesis (SPPS) technology allows for proof-of-concept developments. At the same time, the synthesis processes are optimized utilizing liquid-phase peptide synthesis (LPPS) technology. This dual approach serves to accelerate timelines and decrease manufacturing costs. Subsequently, successful processes can be transitioned to larger manufacturing plants, such as Cambrex’s substantial facility in Charles City, Iowa, where traditional batch reactors are employed for material production. This approach is not only more economically viable but also benefits the scalability needed to reach broader patient populations.

Furthermore, the LPPS technology has been meticulously designed to use conventional batch reactors combined with continuous flow techniques. This innovation eliminates the reliance on specialized solid-phase reactors, thereby significantly minimizing both solvent usage and the necessity for excess reagents that are typically involved in standard solid-state peptide synthesis methods.

Dr. Matt Bio, Chief Scientific Officer at Cambrex, emphasized the importance of identifying the right synthesis method for each development phase. While SPPS plays a crucial role in early-stage clinical trials and proof-of-concept initiatives, it doesn't offer a scalable solution for large-scale drug manufacturing aimed at wider patient populations. Thus, the newly established LPPS process is designed to leverage Cambrex's extensive capacity, which exceeds 1.4 million liters, to meet the demands of peptide therapies effectively.

Cambrex's commitment to innovation and research development continues undeterred, particularly in the realm of complex synthetic methodologies. The company is also delving into integrating artificial intelligence technologies into optimizing oligonucleotide processes, reflecting its forward-thinking attitude and openness to adopting groundbreaking advancements in pharmaceutical technology.

Snapdragon Chemistry stands at the pinnacle of active pharmaceutical ingredient development and manufacturing. Its location in Waltham fosters a deep connection with the local scientific community, bolstered by a talented workforce of over 70 employees, including 31 PhD scientists. This dedicated team is equipped to tackle intricate process and analytical development challenges with their advanced automation technology and proprietary equipment.

In conclusion, the expansion of Cambrex's peptide manufacturing capabilities represents a significant step forward in the pharmaceutical industry, allowing for improved production processes and heightened efficiency in delivering vital peptide therapies. It marks a promising development for the future of pharmaceutical manufacturing and sets the stage for transformative advancements in drug delivery to patients worldwide.