CMO IN BULK LYOPHILISATION LAUNCH
Stirling, UK – STERILE manufacturing specialist Symbiosis Pharmaceutical Services has unveiled a new bulk lyophilisation (freeze drying) service after winning several new contracts in this niche area. The Scotland-based contract manufacturing organisation (CMO) is supporting clients in the US, Europe and Asia to assist with the manufacture of bulk intermediates and APIs by lyophilisation. Although the company has been providing lyophilisation for the sterile filling of vials since its inception, it has now expanded this offering to be able to provide both aseptic and low bioburden clean room dispensing of bulk materials. Colin MacKay, CEO at Symbiosis Pharmaceutical Services, said: “This service launch has very much been driven by market demand from biotech and pharmaceutical companies requiring either a one-off batch or the ongoing bulk lyophilisation of API or finished product. “Our state-of-the-art facilities, licenses and technical capabilities enable us to offer such a service to the market in a reliable and responsive manner, helping meet clients’ product supply needs in a timely fashion.” Over the last few years, Symbiosis has built a strong reputation for offering clients rapid access to sterile manufacturing slots and quick release of drug products to ensure tight clinical trial timelines are successfully met. The company’s biologic and small molecule sterile production capabilities help support biotech and speciality pharmaceutical companies across the world that require products for clinical trials and low volume commercial supply. After taking delivery of API into Symbiosis’ GMP cleanroom suites, the CMO is able to lyophilise product in appropriate freeze drying trays. As part of the new service, it will also support clients with the development of an optimised cycle as well as supporting with analytical and microbial testing, labelling, controlled temperature storage and distribution. “For us, it’s all about adding as much value to clients’ projects as possible in terms of expertise where they need it, while ensuring every batch is produced under stringent compliance and with quality assurance release. “Like every service at Symbiosis, the core is regulatory-compliant and time-focused contract sterile fill/finish,” added Colin. Symbiosis specialises in sterile injectables and the aseptic manufacturing of drug products into vials, which are either liquid or lyophilised 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.