Peptides Manufacturing Capabilities
In the small molecule industry, Lonza knows the complexity of peptide manufacturing. As experts in development and manufacture of both small and large-scale peptides, we welcome the opportunity to help you tackle your peptide challenges and can support you at every stage of your product life cycle. Should your peptide API needs increase significantly, we can help you avoid the common bottlenecks and pitfalls associated with scale-up and multi-kilogram manufacturing.
From early-stage development through commercial market supply, we are ready to meet your immediate and long-term needs with innovative and safe solutions.
To learn more about our Peptides manufacturing facilities visit our site pages:
Isolation and Filtration
From lyophilization techniques to downstream filtration, Lonza has modern equipment and manufacturing experts to provide you with high quality peptide products that meet today’s industry expectations. We offer safely regulated processes to help ensure your product is the best it can be.
- Lab-scale lyophilization (freeze dryers)
- Industrial-scale lyophilization (up to 200kg ice/day)
- Lab- and pilot-scale spray drying
- Agitate and static plate filters
- Extraction devices
Peptide specifications are still driven by traditional small molecule manufacturing. Official regulations for purity and purification are not yet in place, however regulatory guidelines do exist. The European Pharmacopeia just released its first peptide purity regulations at the end of 2010, and the FDA has released guidance emphasizing a Quality by Design (QbD) approach to process validation for the industry. Many companies are not aware of these continual regulatory changes and often challenges arise. Lonza recognizes the need for process regulation and a QbD approach to manufacturing and is committed to the providing you a seamless approach to your peptide pipeline.
Lonza’s Purification Offering:
- Large-scale HPLC (15 to 60cm)
- Mid- and Small-scale HPLC
- Various packing material options
- Up to 100 bar
- Quality Control (IPC methods & HPLC)
Lonza’s multi-site manufacturing, worldwide sales presence and full in-house capabilities contribute to ease of manufacturing for our customers. For early phase or gram-scale demands to large scale peptide production, we offer the necessary assets in Nansha, China and Visp, Switzerland. Our global reach provides the high security of supply you expect from a leading CMO:
- Streamlined (worldwide) sourcing
- Raw materials in rail-tank-cars
- No open handling
- Adequate warehousing
- Recycling systems
- Exhaust gas treatment
- Waste disposal