2. Technology / Service
2.1. Microbial/yeast fermentation
Microbial manufacturing is underpinned by fermentation capability up to 500L scale. We are able to offer a full suite of manufacturing both whole cell preparations, recombinant products from microbial hosts and naturally produced cellular products such as carbohydrates. Processing can be undertaken under GMP or non GMP as needed.
Briefly we can undertake:
– Master and working cell bank preparation, validation and storage
– Fermentation and subsequent downstream purification
– Up and downscale work up optimisation
– Downstream processing optimisation and development
2.2. Vaccines recombinant/bacterial/viral
Vaccine antigen preparation for human or non-clinical studies can be prepared in our facility. We are also able to, under our APVMA licence, prepare finished product for the Australian veterinary market, including storage and distribution.
We are able to offer the following capability and service:
• Dedicated containment area
• Flask or fermentation for recombinant vaccines
• Attenuation or killed preparations
• Antigen capture and stabilization
• Documentation and support services
2.3. Chemical Synthesis
In addition to our biopharmaceutical manufacturing services, we can offer GMP chemical synthesis for a range of chemistries.
Our capability in this area includes:
• Glass and stainless steel controlled reactors up to 150L
• Multiple fume cabinets and chemical and solvent handling infrastructure
• Research quantities to Kilo lab capabilities
• Expertise in carbohydrate chemistry and traditional organic synthesis
• Natural product extraction and purification
2.4. Fill Finish
New service to be available by end of 2017 is the LuinaBio small scale Fill and Finish service. We will be able to fill and finish up to 5,000 vials in GMP to support your early phase trials.
Our facility is designed to meet increasing market demand for small-scale, shorter sterile drug product development timelines, while consistently maintaining regulatory compliance.
Today, we reliably support our customers with the aseptic filling and lyophilization of both small molecule and biologic drugs into vials. Helping clients across the globe meet their project milestones, we provide rapid access to manufacturing slots and quick release of drug product to ensure tight timelines are successfully met.
Our sterile fill finish capabilities include
2.5. Single use
At LuinaBio we have the following single technologies available for clients to address your specialized needs of biotherapeutic development and manufacturing. These include
2.6. Bulk Lyophilisation
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) by lyophilization.
Our facilities enable us to deliver such a lyophilization service by either aseptic or low bioburden clean room dispensing of up to 100 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.
2.9. 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 (insert brand name here) homogenizer allows us to PLEASE INSERT MAIN BENEFITS HERE.
2.10. Anaerobic fermentation
Luina Bio is highly experienced in working with strict anaerobic cultures.
Our capability in this area includes:
• –Anaerobic cellbank preparation and qualification
• –Anaerobic fermentation up to 500L
• –Anaerobic mid stream and downstream processing
• –Anaerobic lyophilisation of live cultures
• –Anaerobic product packaging
2.11. GMP cell banking
LuinaBio offers significant expertise and experience in establishing and maintaining cGMP cell banks. We operate and maintain a self-contained cell banking suite for the manufacture of microbial master cell banks and working cell banks. Our facilities operate according to TGA guidelines, offers both aerobic and anaerobic conditions and is environmentally monitored. We offer in-house release and stability testing of cell banks and short and long term storage in qualified freezers under continuous temperature monitoring.