Chemi Peptides is a dedicated unit of Chemi SpA, which has a long-term expertise in the development and production of pharmaceutical peptides from R&D to commercial scale.
Since 1996 Chemi Peptides has been advancing its know-how in Peptides technology and manufacturing, leveraging a team of peptide chemistry experts within Italfarmaco.
Initially involved in the industrial GMP production of peptidic advanced intermediates on a custom manufacturing base, Chemi later focused mainly on both natural and modified API peptides (generics, complex generics, and proprietary peptides).
Synthesis of Complex or Modified short peptides (max 15-20 AAs or AADs, also unnatural)
Convergent & Minimal protection strategy, for more sustainable processes (low PMI manufacturing)
Management of coupling reactions with control of racemization, for a high stereogenic quality of the final API
Development and validation of complex methods for IPC, release and peptide characterization
GMP manufacturing, featured by isolation and quality characterization of the intermediates
Proprietary know-how in synthetic methods (i.e. non oxidative mono and multi disulfide bridges formation)
Custom Development Capabilities (e.g. challenging cyclization, aminoacid modification, cluster of basic peptides)
TAG Assisted Peptide Synthesis (TAPS): as part of our ongoing innovation process, we are evaluating and implementing TAPS technology, tailoring it to our expertise.
Chemi Peptides is extensively experienced on Industrial Solution Phase Peptide Synthesis (LPPS), both stepwise and by fragments condensation.
Added values:
Early development of synthetic (and purification) process, no limits for process scale-up
Stable Impurities profile, from the development to the commercial batches
Best choice for short/medium and modified peptides
(stepwise and/or by fragment condensation)
The downstream process (purification of the crude peptide and isolation of the final API) is the common bottleneck for all manufacturing strategies.
Chemi Peptides owns an original know-how for reversed phase peptides purification: the High-Performance Displacement Chromatography (HPDC).
This technique allows for an extremely effective purification while lowers the consumption of stationary phase and solvents, ensuring the sustainability of the process.
High Performance Displacement Chromatography (HPDC)
Purification of the crude peptide by reversed phase chromatography
Ion Exchange Chromatography (IEC)
Right counter-ion introduction and removal of impurities with different charge
Reverse Osmosis
Process for removal of the salts and concentration
Ultrafiltration
Deiprogenation
Freeze-drying
Packaging
Aqueous-based technique (10-15% solvents max), greener than traditional methods
High loading (e.g. up to 0.4 kg for each run in 25 cm ID column)
A more sustainable process, due to a lower consumption of stationary phase and solvents
High peptide concentration in the fractions (typical 15-25 g/l)
Identification of the critical impurities since the first stages of the development (because of the high concentration/enrichment of the impurities in defined fractions)
Easy scale-up and reproducibility from Lab-scale (0.46 cm ID column) to commercial scale (60 cm ID column factor scale-up = 21096)
Typical chromatographic yield: 80-90% calculated on peptide content