Use our 20 years of experience in processing technologies, large scale centrifugation, ultrafiltration, and high-pressure cell disruption to accelerate your project. We have the unique experience of adapting each of these technologies to microbial biomanufacturing and the facilities needed to deliver the highest quality.

Luina Bio has a TGA license for the biopharmaceutical manufacturing of human therapeutic APIs from both biological and synthetic sources. We handle all stages of API manufacturing from preclinical through Phases I to III clinical development and into the marketplace.

Our facilities enable us to deliver lyophilization service with either an aseptic or low-bioburden clean room dispensing up to 32 liters of bulk product per batch. Whether you require a one-off batch or ongoing bulk lyophilization of API or finished product, our technical experts will support your supply needs and product development.

Large scale centrifugation has long been the principal means of separating cell mass from fermentation media at scale. 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 retain large solutes and eliminate unwanted smaller components.

The key to a successful process is the selection of the correct filter. At Luina Bio, we work closely with all major filter manufacturers to ensure you have the correct filter for your process.

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, also called high-pressure cell disruption, 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.

The benefits of single-use technologies in biomanufacturing include cost savings, reduced risk of product contamination, and increased flexibility in multi-product facilities.