PolyPeptide Laboratories provides several strategies for peptide synthesis to support projects of any size. We can handle peptide production from small-scale (multi-10 mg) non-GMP batches to multi-10 kg (and larger) GMP manufacturing needs. Our production chemists and analytical development team have extensive experience with a large variety of peptides and synthetic strategies at all scales, and we can help optimize your project by developing the most robust, economical manufacturing processes.
We excel in all major peptide technologies:
Liquid (Solution) Phase Peptide Synthesis (LPPS)
LPPS is the technology of choice for many peptides, particularly shorter peptides or structures that prevent attachment to a resin matrix. LPPS is especially appropriate for shorter sequences that need to be manufactured at large scale.
Solid Phase Peptide Synthesis (SPPS)
SPPS is well-suited to manufacturing peptide APIs, particularly longer, more complex sequences. PolyPeptide Laboratories has extensive experience in both Fmoc and t-Boc strategies, and we will work with you to decide on the best approach, depending on your specific sequence and your final requirements. We have the capacity to manufacture quantities of peptides up to 200 kg with complex sequences using SPPS.
Hybrid Synthesis for Larger Scales
Using a hybrid fragment strategy, small peptide fragments are synthesized using SPPS and then joined in solution to form longer peptides. For longer sequences, hybrid fragment synthesis offers an economic method to scale up the manufacturing process. Not all peptides are amenable to hybrid fragment synthesis. For some peptides, it may be the manufacturing method of choice, independent of scale.
Purification
The right purification strategy is critical for your project's success. Notwithstanding the increasingly strict requirements regarding product purity and related substances, purification is a major cost factor in manufacturing most peptides. Reverse Phase HPLC is the most common technology for peptide purification; in addition to HPLC, PolyPeptide Laboratories also has considerable experience with ion exchange, size exclusion and other forms of chromatography.
Large-Scale Purification
Large-scale purification is accomplished with HPLC columns up to 60 cm internal diameter and low-pressure columns up to 1 meter in diameter.
Isolation/Lyophilization
Lyophilization is the normal procedure used for final isolation. PolyPeptide Laboratories is equipped with both flask lyophilizers (used to isolate peptide APIs) as well as tray lyophilizers (up to 200 L of ice capacity) on both sides of the Atlantic. As appropriate, we may also explore alternatives such as precipitation and spray drying, which can be scaled up to increase throughput in large-scale processes.
