Request for accredited biosimilar characterisation services for locally produced Bevacizumab monoclonal antibody, adhering to SAHPRA and WHO guidelines. This RFQ aims to ensure compliance and quality in biopharmaceutical development.
The Council for Scientific and Industrial Research (CSIR) is seeking quotations for accredited biosimilar characterisation services specifically for the locally produced Bevacizumab monoclonal antibody. This tender requires service providers to demonstrate compliance with the stringent guidelines set forth by the South African Health Products Regulatory Authority (SAHPRA) and the World Health Organization (WHO). The successful bidder will be tasked with conducting comprehensive characterisation studies that validate the biosimilarity of the monoclonal antibody, ensuring it meets all regulatory standards for safety, efficacy, and quality.
The scope of work includes a detailed analysis of the biosimilar product, encompassing physicochemical characterisation, biological activity assessments, and immunogenicity studies. Providers must have the necessary accreditation and expertise in biosimilar development, as well as access to advanced analytical technologies. This project not only supports the local biopharmaceutical industry but also contributes to the broader goal of improving patient access to essential medications. Interested parties should prepare to submit their quotations by the closing date, ensuring all documentation is complete and compliant with the requirements outlined in the tender documents.
This tender is suitable for accredited laboratories and biopharmaceutical companies with expertise in biosimilar development and characterisation. Businesses with experience in regulatory compliance and advanced analytical techniques are encouraged to apply.