LuinaBio has a TGA license for the manufacture of human therapeutic APIs from both biological and synthetic sources. We are cost competitive, and have the resources and expertise to handle all stages of API manufacturing from pre-clinical, through phases I to III clinical development and into the marketplace.
Our facilities enable us to deliver such a lyophilization service by either aseptic or low bioburden clean room dispensing of up to 32 litres of bulk product per batch. Whether you require a one-off batch or the ongoing bulk lyophilization of API or finished product, our technical experts can support your supply needs and your product development.
For several years, our expertise in lyophilization (freeze-drying) has been used by clients from around the world to assist with the manufacture of investigational bulk intermediates and Active Pharmaceutical Ingredients (APIs).
Centrifugation has long been the principal means of separating cell mass from fermentation media. Luina Bio primarily uses Alfa Laval continuous flow centrifuges for this purpose. For smaller operations, a Beckman Coulter batch centrifuge is also available in the GMP manufacturing suites.
Tangential Flow Filtration (TFF)/Ultrafiltration is widely used in biopharmaceutical manufacturing to separate particles according to size. This allows us to separate whole cells from bulk fermentation media, eliminate colloids and cell debris from an expressed active ingredient or to retain large solutes and eliminate unwanted smaller components.
The key to a successful process is the selection of the correct filter, and at Luina Bio we work closely with all major filter manufacturers to ensure the correct filter is chosen for your specific process.
High Pressure Cell Disruption
The disruption of a cell’s wall is often a primary step in product isolation, particularly when hosts such as Escherichia coli and Saccharomyces cerevisiae, which generally do not excrete product, are employed. Of the available methods, high-pressure homogenization is dominant at moderate or large process volumes.
Our Niro Soavi homogenizer allows us to process the cell mass obtained from our largest fermenter in a timely, hygienic manner.