Peptide development, manufacturing and analysis

We have specialised facilities and expertise for peptide development, manufacturing and analysis with high standards for quality and compliance.

For many pharmaceutical organisations exploring targeted therapeutics across a variety of indications, peptides have become a key focus area. At Sterling, we provide the extensive expertise, specialised equipment, and comprehensive analytical capabilities needed to support the complexity of peptide synthesis and develop high-quality products for our customers. ... Read more

Our peptide development offering is critical to the successful production of preclinical, clinical and commercial peptide therapeutics. Our range of expertise include analytical services such as product characterisation, development and validation of methods, stability studies and impurity identification. Chemical process development provides methods such as research leading to the production of GLP and GMP materials, QbD, and development of purification methods.

Our peptide development technology at our North Carolina, US facility includes:

• Gyros peptide technology symphony X 24 channel parallel SPPS synthesiser to identify optimal parameters for peptide manufacture at scale
• YMC dual column prep HPLC system to identify conditions for the purification of peptides at scale
• TFF system to concentrate, desalt and separate small molecular weight impurities from larger peptide fragments/APIs of interest
• Laboratory with expertise in development, troubleshooting, process optimisation (including new silica types and base resins), and chromagraphic method development for peptide purification

Our peptide manufacturing expertise spans both clinical and commercial supply. We have a dedicated peptides facility for small scale manufacture and a range of multi-purpose equipment suitable for larger volumes and long chain complex peptides.  In addition, we have tank farm capacity to support large solvent volumes, and we can install additional chromatography equipment to support specific use cases.

Our peptide synthesis, manufacturing and purification technology at our Cork, EU facility includes:

• Two peptide synthesisers, one column with 50L capacity and one stirred reactor with 170L capacity
• A range of agitated filter dryers from 0.32 to 6.0m² for peptide synthesis and cleavage
• Four HPLC columns ranging from 45cm to 1.6m diameter
• Three ion exchange columns, with 20L to 150L capacity
• Eight lyophilisers from 3kg to 80kg, or 50L to 1,000L capacity
• Headtanks and reactors from 50L to 10,000L capacity

Our facilities are home to dedicated analytical laboratories to support the analysis and release of peptides for clinical and commercial production. Our laboratories includes comprehensive equipment for a broad range of complex analytical requirements, including nuclear magnetic resonance (NMR), liquid chromatography mass spectrometry (LCMS), and inductively coupled plasma optical emission spectroscopy (ICP-OES). Our team’s expertise enables us to efficiently handle challenging analyses and generate comprehensive data to inform our customers and support regulatory filings.

Along with our comprehensive development, manufacturing and analytical services, we provide expertise in several additional areas for enhanced efficiency, sustainability and versatility in your peptide programme.

• Low bioburden manufacturing environment, with cleanrooms, steam-in-place (SIP), purified water, and microbiological cleaning validation
• Support for cold chain transport, with 20 years of experience in peptide ‘frigo’ (2-8°C) conditions
• State-of-the-art waste treatment facilities, with liquid vapour incinerator (LVI) and redundant vapour treatment (RVT) capabilities to treat solvents and gases, and IEL-licensed biological wastewater treatment plant to minimise environmental footprint
• Solvent recovery capabilities to purify high-cost process solvents for reuse
• Proven track record in the manufacture of peptide drug substance for use in sterile drug product manufacture