Austar Compliance Consulting Services (Austar) has announced its support for the multi-product biopharma facilities in providing validation and consulting services for its several plasmid production lines.
Austar is also providing one mRNA single-use production line that helps clients maintain quality and compliance for cGMP regulated products.
The company’s client is an innovative technology company focusing on nucleic acid process development and application, aiming at providing one-stop CDMO services for the entire industry chain from product development, quality research, and clinical application to the industrialisation of cell therapy and nucleic acid drugs.
In February 2022, AUSTAR Compliance Consulting Services is honoured to be chosen as the validation and consulting service provider for one of its GMP production bases (8500㎡), which is designed by a world-class company in accordance with international standards (NMPA, EMA, FDA), built with several plasmid production lines and one mRNA single-use production line, and capable to meet the requirements for GMP-compliant sample production and release at phases such as IIT, Pre-IND, IND, clinical trial samples and commercial product production.
The company is set to offer C&Q preliminary consultation and validation services for utility systems, manufacturing and storage facilities, and laboratory equipment, etc. Additionally, as the responsible party of supplier management, Austar is “committed to building an effective communication bridge between suppliers and the client, ensuring execution efficiency and progress”.
