QC, Analytical Testing & Process Development
Our team of experts can provide comprehensive solutions and strategies for process development, quality control assay development, supply of pre-clinical and shipping studies.
QC & Analytical Testing
Ensuring the safety, potency, and efficacy of cellular products requires rigorous quality control (QC) and analytical testing prior to release. This expertise is critical to ensure high quality medicines are available to patients. We offer a wide range of analytical and Quality control testing with a focus on biological including cell and gene therapy materials and products. Some of our QC & analytical capabilities include:
- Mycoplasma testing
- Flow Cytometry
- Sterility testing
- Potency assays
- Endotoxin testing
Process Development
Our team will work together with you in assessing your current manufacturing process to identify potential improvements and create a process development strategy to meet your needs. We can take your process into our R&D laboratory to identify gaps and make the process more robust. We will work with you through the entire process and assess key parameters of the process such as starting materials, raw materials, manufacturing steps and quality control assays. Our services range from:
- Manufacture and supply pre-clinical product as required for studies to enhance the development of your product
- Developing and designing QC assays
- Establishment of preclinical or research cell banks
- Adherent and suspension-based cell culture
- Media screening and selection
- Bioreactor process development
- Harvest optimisation