Complete Laboratory Pilot Plant

The plant was initial designed and installed for purifying antibodies (IgG) from frozen bovine colostrum. The capacity was set at 20 litre batches, hence able to process the output from at least 1 cow. The final output is at two purity levels of IgG – 55% or 98% - and product is in the form of a white freeze dried powder. Pilot plant is fully operational and equipped with appropriate consumables, balances, Ph meters etc. All the equipment was purchased, installed and commissioned March – June 2018. The plant was operational (single shift operation) until July 2019 and then “mothballed” until the present day. The highly purified antibodies were used successfully in pre-clinical trials. Standard operating procedures for all equipment are available and the whole was GMP compliant although registration was not being sought until phase 1 clinical trials were initiated. Plant includes: 1. Three stainless steel processing tanks able to be heated and cooled very precisely. Processing volume is 5 – 20 litres per tank. Melt tank, Pasteurising tank, and cooling module (used to produce whey etc.) The cooling module is specified to deal with batches up to 100 litres. The equipment was designed and built by Thermaflo Limited, Palmerston North, New Zealand. 2. 6 litre 10,000g centrifuge for fat removal etc. Sorvall Lynx 6000 Superspeed 3. GE Healthcare AKATA Flux S system is a versatile cross-flow filtration system for sample concentration and diafiltration. It allows effortless filtrations using cassettes and hollow fiber filter cartridges Semiautomated features enable end-point control, constant retentate volume and data logging. 4. GE Healthcare AKATA Pure 25 system is a flexible and intuitive purification system for proteins, peptides, and nucleic acids from microgram levels to tens of grams of target product in research applications. Ideally suited for running protein G Sepharose columns. 5. Biological safety cabinet, 1.2m, sterile, fully certified class 2. 6. Freeze drier, 6 litre capacity, with auto stopper of vials facility and nitrogen back fill. Item: LAC700621140, Freeze Dryer, 6l, -50oC with stoppering tray dryer. Item: LAC7739403, Vacuum Pump with filter exhaust, 195 litres/min AllAssemblyKB1 5420