We offer process development and vaccine manufacturing services from our GMP-approved facility in Auckland. Our manufacturing suites are state-of-the-art and ISO-certified. We have formulated and produced many different vaccines that have since been exported to Australia and all over Europe.
We produce viral and bacterial vaccines using a cell culture platform, which is reliable, fast, and suitable for large-scale manufacturing. We maintain master and working cell stocks, and master and working seed stocks. Our analytical capabilities include spectrophotometry, fluorimetry, reverse phase and ion exchange chromatography, high-pressure liquid chromatography, PCR, LAL, SDS-PAGE, ELISA, bioburden, capillary electrophoresis, TCID assays, and particle size analysis. Stability testing is performed according to the ICH guidelines for Drug Substance & Product.
At BioCell, manufacturing high-quality, sterile products is our priority. We follow Good Manufacturing Practices throughout the manufacturing and testing processes to ensure the production of high-quality vaccines. In line with GMP-compliance, our quality control processes include thorough documentation throughout the manufacturing process, frequent validation of practices, qualification of equipment, and regular internal and external audits, as well as calibrating, cleaning, and maintaining all facilities and equipment.
Our experienced team provides formulation, filling and packing services, allowing for complete production capabilities from start to ‘fill & finish’. We are able to produce small scale batches and commercial scale batches. So, whether you are in the early stages of development, clinical trials, or ready for commercial scale production, we can help. Talk to us today!