Your Proven Peptide Manufacturing Partner
Since high-quality peptide APIs are essential for synthesizing advanced peptide-based therapeutics, it’s important to choose a reliable supplier.
With decades of scientific, manufacturing and regulatory expertise, and a fully-integrated supply solution across drug substance and drug product manufacturing, we are the peptide partner you need for the effective production of peptide APIs from clinical development stages through successful commercialization to market.
Integrated Peptide Supply
- Our peptides platform supplies you with specialized combined expertise across multiple cGMP facilities from early-stage to commercial supply of advanced peptide APIs. Our successfully inspected cGMP facilities produce a wide range of peptide products for various therapeutic indications.
- To increase your R&D throughput, our European R&D Centre of Excellence provides support across our globally integrated facility network with process design development and GMP manufacturing.
- Our GMP sterile injectable facility provides formulation development and manufacturing for aseptic and terminal sterilization fill and finish in pre-filled Syringes (PFS), ampoules, liquid and lyophilized vials, as well as combination device products, and packaging/labeling.
Scientific Expertise
- Our peptide development and scale-up approach is enhanced with Quality by Design (QbD) using scale down equipment that mimics large-scale production assets to identify and avoid deviations in initial equipment design.
- Innovative and advanced process technologies provide access to a wide range of peptide structures resulting in cost-effective manufacturing, with robust CMC dossiers. Our approach reduces the number of chemical steps, increases purity and yield, decreases raw material cost contribution, and improves overall Process Mass Intensity (PMI).
- Our core peptide products and services include:
- Complex peptides & peptidomimetics
- Peptide conjugation (PEGs, proteins, lipids, carbohydrates)
- Cyclic & multiple disulfide bridge peptides
- Short peptides (up to 12 residues), often without HPLC purification
- As an industry leader in the peptide market, we understand the regulatory requirements you will encounter along the clinical and commercial stages of your development path.
- Analytical development and validation services consist of comprehensive support to enable clinical development and commercial manufacturing.
Proven Peptide Manufacturing
- Solid-Phase Peptide Synthesis (SPPS)
- Automated fully GMP reactors ranging from 12 L to 10,000 L to produce grams to multi-100-kilogram quantities per batch under cGMP with dedicated peptide lines
- Robust and efficient production of large-scale commercial peptides embedded into large-volume solvent & waste-handling logistics, warehouse & site infrastructure
- Liquid-Phase Peptide Synthesis (LPPS)
- Technology of choice for cost-effective large-scale manufacturing of short peptides or structures not easily prepared by SPPS
- Hybrid fragment coupling of shorter SPPS-generated sequences in solution
- Cyclization manufacturing of commercial peptides containing a single or multiple disulfide bridges or cyclized lactam peptides
- Purification
- Reach or exceed the required purity at any scale, leveraging preparative High-Pressure Liquid Chromatography (HPLC) technology
- Automated reverse-phase HPLC with columns up to 100 cm in diameter, supported by different ion exchange chromatography columns
- Isolation
- Traditional final isolation using lyophilization or spray drying
- Alternate isolation technique via precipitation process reduces cost and improves API handling at the drug product site with easy scale-up and transfer
- Ability to precipitate any peptide upon request (including long peptides with more than 35 amino acids)
Your Benefits > Our Strengths
1) Fast & Lean Process Development > Scientific Expertise
Advance through your milestones with greater efficiency by harnessing our Quality by Design method that cuts development time across thousands of steps.
2) Faster Time to Market with Reduced Cost > Streamlined Fully-Integrated Supply
Discover how our fully integrated supply services, ranging from GMP starting materials to drug substance, fill and finish drug products, and packaging, enable faster times to clinical trials and market with reduced costs.
3) Proven Peptide Production > Over 130 Years of Combined Peptide Manufacturing Experience
Receive superior peptide API processes using both SPPS and LPPS technologies from gram-scale to the largest worldwide multi-ton peptide capacity available.
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Seamless Integration Across the Supply Chain
Working and coordinating with several providers can be demanding and time-consuming when outsourcing a project. We aim to streamline your process, improve efficiency, and reduce costs by consolidating multiple services in one organization. As your CDMO partner, we work alongside you to understand and anticipate your project needs.
We deliver them through seamlessly integrated technologies and services from across our expert global network that support the development and manufacture of pharmaceutical and biotech innovators’ complex modalities. Our bespoke end-to-end solutions span your supply chain, covering all stages from drug development to commercialization.
