Symbiosis Pharmaceutical Services, a contract sterile manufacturer based in Stirling, Scotland, has launched a new bulk lyophilization service after winning several new contracts in this niche area. The contract manufacturing organization is supporting clients in the US, Europe, and Asia to assist with the manufacture of bulk intermediates and active pharmaceutical ingredients (APIs) by lyophilization. The company provides lyophilization for the sterile filling of vials as part of its core competency, but it has now expanded this offering to be able to provide both aseptic and low-bioburden cleanroom dispensing of bulk materials.

The company's biologic and small-molecule sterile production capabilities help support products for clinical trials and low-volume commercial supply. After taking delivery of the API into Symbiosis' GMP cleanroom suites, the company is able to lyophilize product in appropriate freeze-drying trays. As part of the new service, it will also support clients with the development of an optimized cycle as well as supporting with analytical and microbial testing, labelling, controlled temperature storage, and distribution.

Symbiosis specialises in sterile injectables and the aseptic manufacturing of drug products into vials, which are either liquid or lyophilized formulations filled into vials. Its core manufacturing capability takes place within a purpose-built facility in Scotland, designed for the manufacture of sterile drug products.

Source: Symbiosis