News & Events

Symbiosis completes full clean room qualification

Symbiosis successfully completes the full qualification of its two sterile fill/finish and lyophilisation cleanroom suites.

Symbiosis is delighted to announce that it has successfully completed the further qualification of its pharmaceutical manufacturing processes to cover an extensive range of vial sizes in both of its sterile fill/finish and lyophilzation cleanroom suites. Symbiosis has manufacturing suites dedicated to the sterile fill/finish of cytotoxic drugs and conventional drugs (including small molecule drugs and biologic drugs) respectively. By completing twenty successful manufacturing process simulations (SIMs), necessary as part of the aseptic assurance qualification program for sterile manufacturing processes, the Symbiosis aseptic filling capabilities are now qualified to accommodate a wider range of client clinical manufacturing needs. This consolidates the capability of Symbiosis to fast-track the development if its clients’ products, taking those novel drugs from the pre-clinical to the clinical trials stage in a way that saves its clients valuable development time. Qualifying aseptic manufacturing processes uses nutrient rich broth media instead of drug product and enables the demonstration of assurance of sterile production techniques. This is a pre-requisite for the specialist manufacture of injectable drug products and gives our clients the highest confidence in the Symbiosis sterile fill finish manufacturing standards.

Fintan Weston, Symbiosis Manufacturing Director commented “After defining the optimal manufacturing processes and training our team of highly-skilled technicians, we have continued to measure and improve our operational efficiency and extend our service capabilities through this kind of process qualification. As part of our continuous improvement program, these successful simulations are important in demonstrating we have achieved the full range of operational capabilities that we aspired to for both of our sterile manufacturing cleanroom areas.  We look forward to the continued broadening of our capabilities in the near future to reflect the demands of our biotechnology company clients”.

From its World Class facility Symbiosis offers sterile cGMP manufacturing of liquid or lyophilised injectable drug products in vials.With tailored batch sizes up to 3,000 vials in the 2ml – 50mL range, Symbiosis are perfectly placed to support pre-clinical, Phase I and Phase II clinical trial requirements for injectable biologics or small molecule drug products worldwide.

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