Contract GXP Services
Statens Serum Institut (SSI) has more than 100 years of experience in research, development and manufacturing of biopharmaceuticals. Vaccine Development have produced more than 20 biopharmaceuticals and contributed to more than 30 clinical trials the last 15 years.
SSI's Vaccine Development Department offers its expertise within GXP services. Besides the services outlined below, our experienced and dedicated team also offers customized services, so if the service you request is not outlined below, please contact us anyway and our dedicated team will do its utmost to try to help you find a solution. Besides contract work, we also enter into research collaborations.
VUA has the expertise and competences for taking vaccine candidates from research through fast track GMP development into the first clinical trials. Our competences include cloning into bacterial systems, process and analytical development for subunit proteins, formulation with adjuvants, coordination of toxicology studies and clinical trials.
VUA has the interdisciplinary expertise of making fast track development possible through integrating all disciplines up front. CVR/SSI has a Quality Management System (QMS) covering GMP, GCP and GDP as well as regulatory process expertise. The close collaboration with SSI´s QA department with Qualified Person (QP) ensures the quality standards required for supply of product for clinical trials and for documents and procedures for regulatory submissions.
Pre-Clinical and Clinical Product Supply
- Pilot plant facilities certified by the Danish Medicines Agency
- Flexibility through high reliance on disposable technology
- Class C pilot plant facilities for drug substance GMP production
- Development of product formulation and technology
Support to Pre-clinical and Clinical Trials
- Setup pre-clinical trials including assistance on trial design and vendor selection
- Assist in the preparation of Clinical Development Plans for new products
- Clinical trial setup including assistance on trial design, site selection, regulatory and ethics committee submissions according to relevant ICH guidelines and national law
- Clinical trial conduct and monitoring according to ICH guideline on Good Clinical Practice
- Reporting of preclinical and clinical trial according to relevant ICH guidelines
- Packing, labeling and shipment to clinical sites
Our highly skilled QA professionals are issuing all documents related to manufacture and controls, perform batch record reviews and QP releases. All quality assurance procedures are cGMP compliant. All clinical trials conducted according to cGCP.
Who We Are
|AREAS OF INTEREST/RESEARCH
|Active pharmaceutical development
|Drug product, analyses, CAF adjuvants
|Clinical and non-Clinical Development
|Head of Department
FAIR (Flagellin Aerosol therapy as an Immunomodulatory adjunct to the antibiotic treatment of drug-Resistant bacterial pneumonia).
Rapid evaluation of Plasmodium falciparum Transmission Blocking Vaccine (PfTBV) candidates through enhanced African Resource Centers (ARC) for integration into malaria control and elimination.