Peptides

Cambrex and Snapdragon Chemistry, a Cambrex company, together provide comprehensive capabilities to help you develop and manufacture peptides and complex synthetics. We have developed several technologies to enable robust and reproducible cGMP manufacture.

Peptide Development and Manufacturing

To reduce the economic and environmental impacts of manufacturing peptides, Snapdragon Chemistry has invested extensively in R&D to design a liquid-phase peptide synthesis (LPPS) technology that utilizes traditional batch reactors and continuous flow, obviating the dependency on specialized, solid-phase reactors. This new LPPS technology reduces solvent demand and the need for excess reagents compared to standard solid-state peptide synthesis processes.

The LPPS technology supports peptides up to 12 residues long, while larger peptides are then assembled in liquid phase, using a convergent fragment coupling approach. Combined with convergent fragment couplings, the technology enables the entire manufacture of peptide therapeutics without requiring specialized reactors. The technology is also fully compatible with both Fmoc and Cbz protecting group strategies, even within the same peptide fragment.

Processes developed with our LPPS technology can be scaled in the same way as traditional small molecules. The LPPS technology provides a significantly more cost-efficient and environmentally sustainable solution when compared to traditional solid-phase peptide synthesis, allowing for the substitution of sustainable solvents such as 2-methyltetrahydrofuran in place of problematic solvents like the N,N-dimethylformamide typically used in SPPS.

Peptide Crystallization

Peptides present increased complexity for crystallization due to the large size and flexibility of the molecules, leading to a much smaller crystallization operating range compared to small molecules. They have a high risk of gelling, fibrillation and aggregation, often leading to low-purity results and high residual solvent contents. If solids are recovered, they are often isolated as amorphous solids, which can be difficult to handle – both during production and during further formulation steps.

In parallel with our investment in LPPS technology, Cambrex has developed unique peptide and protein crystallization capabilities. We have designed a crystallization screening platform specifically for the discovery of crystalline forms of peptides and proteins. Crystallization can deliver improved product quality and stability and reduce the need for time-consuming preparative chromatography and lyophilization, in addition to:

• Significant impurity rejection
• Improved processability
• Reduced hygroscopicity
• Increased stability
• Control of aggregation & gelling
• Full structural determination
• Cost advantage when compared to column chromatography methods for purification

Analytical Support

Cambrex has established state-of-the-art analytical capabilities to complement our development services, including high-resolution mass spectrometry and peptide sequencing capabilities to support peptide development, process characterization and commercialization needs.