Scale-Up

Our FDA and Swiss Medic inspected GMP facility in Liestal, Switzerland employs a streamlined project management system that ensures timely progression from the research and development process through scale-up to routine full-scale API synthesis or manufacture of critical excipients.

Chemistry

Genzyme offers excellence in process chemistry by developing optimized synthetic routes for complex peptides and peptidomimetics, including in-house production of non-natural amino acids and pseudoproline dipeptide building blocks for economical scale-up and production. Our custom peptide manufacturing technologies include both large-scale solid phase peptide synthesis (SPPS) as well as solution phase peptide synthesis. Very often, combinations of these two techniques are used. Genzyme Pharmaceuticals may also draw on its on-site expertise in carbohydrate synthesis and lipid chemistry to produce corresponding peptide conjugates.

Equipment

Genzyme offers a complete series of manufacturing equipment from 20 to 2500 liters. This is complemented by high pressure reactions, chromatographic purifications, and various drying techniques including lyophilization.

Supply Chain Management

The Liestal facility incorporates state-of-the-art logistics from raw material receipt to final product shipment. A stringent quality management system, supported by Genzyme’s global Corporate Quality Management, ensures reliable analytical testing, acceptance and release of high quality raw materials for production. Our manufacturing capacity is supplemented by strong relationships with our vendors and production partners. The successful transfer and scale up of more than 300 chemical steps highlights this well-established system, which provides a stable source of critical intermediates and the confidence that Genzyme Pharmaceuticals can react quickly to sudden changes in production schedules or volumes ranging from single kilo to multi-tons.

Regulatory

Genzyme Pharmaceuticals can incrementally provide GMP material suitable for Phase I, up through to commercialization. This provides acceptable regulated material for (pre)clinical testing, while keeping GMP service costs to a minimum. Ultimately, a full DMF can be compiled and filed to support the customer’s regulatory activities. Alternatively, Genzyme Pharmaceuticals can provide drug substance related CMC sections in the Common Technical Document (CTD) format for customer’s registration dossiers.