LuinaBio can help you with a range of deliverables/final products depending on your project goals and development stage. This includes:
Non-GMP, high quality, and GMP plasmid DNA manufacturing for preclinical, clinical and commercial supply. Since xxx , our success has come from the experience and expertise gained as a solution provider for DNA vaccines and gene therapies. xxx
LuinaBio knows the complexity of protein biosynthesis. As experts in development and manufacture of both small and large-scale proteins, we welcome the opportunity to support you at every stage of your product life cycle. Should your protein API needs increase significantly, we can help you avoid the common bottlenecks and pitfalls associated with scale-up and multi-kilogram manufacturing. From early-stage development through commercial market supply, we are ready to meet your immediate and long-term needs with innovative and safe solutions.
We have experience in manufacturing peptide vaccines. From preclinical scale to clinical-scale to commercial vaccine manufacturing, our cGMP-compliant manufacturing capabilities complement our testing services to provide you with a comprehensive portfolio of services for your biopharmaceutical product from a single, harmonized source.
• cGMP virus and cell banking
• Vaccine manufacturing via cell culture
• Vaccines for clinical trials (manufacturing scale – up to 5,000 vials per batch)
• Pilot-scale virus manufacturing
The term Live Microbial Product (LMP) or Live Biotherapeutic Product (LBP) refers to products containing whole, live microorganisms, such as bacteria or yeast with an intended therapeutic or
preventive effect in humans, regardless of the route of administration (oral, topical, intravenous, etc.). LuinaBio’s experience in working with Live Microbial Products, with both aerobic and anaerobic products, involves amongst others the development of scalable and fully closed mono-septic production processes (full aseptic handling from fermentation till filling of the product, capable to be administered as parenteral). LuinaBio has experience in working with many different types of Live Microbial Products and helped its customers to create a robust and controlled process, which gives the ability to move products through the various clinical phases towards commercial launch.
1.5. Small molecules
LuinaBio has experience in small molecule synthesis with a particular depth of experience in carbohydrate chemistry. Its equipment allows LuinaBio to synthesize small batches in cGMP and to modify the molecules produced by fermentation.
LuinaBio accommodates products in pre-clinical scale development, as well as more substantial clinical and niche commercial scale fill lots. In offering the latest in vial fill line technology and liquid and lyophilized scale-up process development services, we provide an all-inclusive service to clients which allows for alternate processing during this variable evaluation period.
LuinaBio provides investigational product manufacturing, labelling, packaging, warehousing and distribution services for companies and research institutes undertaking clinical trials. Our GMP and GCP manufacturing and warehousing facilities in Queensland manufacture, warehouse and distribute clinical supplies for use in Australia and New Zealand.
Our facilities (all monitored 24/7) include:
• Quarantined storage of Clinical Trial Supplies prior to local ethics approvals to enable faster trial start up
• Temperature controlled warehouse at 22˚C ± 2˚C
• Refrigerated warehouse at 2˚C-8˚C
• Freezers (-20˚C, -80 ˚C)
• Dedicated finished product warehouse for distribution to clinical sites
Our services include:
• Distribution to clinical sites, locally, interstate and internationally (NZ)
• Permit applications (AQIS, Drugs of Addiction etc)
• Review of stability data, temperature logs and certificates of analysis prior release of product or on receipt of overseas shipments
• Established recall procedures