Validation and Consulting Services for GMP Plasmid & mRNA Single-use Manufacturing Base

AUSTAR Compliance Consulting Services was delighted to support the multi-product biopharma facilities in providing validation and consulting services for its several plasmid production lines and one mRNA single-use production line that help clients maintain quality and compliance for cGMP regulated products.

Our 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 industrialization of cell therapy and nucleic acid drugs. In February 2022, AUSTAR Compliance Consulting Services is honored 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

AUSTAR Compliance Consulting Services is 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 Compliance Consulting Services is committed to building an effective communication bridge between suppliers and the client, ensuring execution efficiency and progress.

Currently, our experts are working closely with the project team of the client to drive the implementation of the project with regulatory compliance, validation, and project management capabilities.