Svar Life Science recently announced the expansion of its biologics testing capacity with a GMP certification. Svar's QC laboratories have been inspected by an independent auditor (Swedish Medical Products Agency) and approved to begin QC analysis in line with the applicable GMP regulations for potency testing of biologics.
The company has been awarded Good Manufacturing Practice (GMP) certification and announced it will be providing customers with QC Testing Services in accordance with the international quality assurance guidelines with immediate effect.
Commenting on the announcement, Anne Thjømøe, CEO of Svar Life Science, said: "Being awarded the GMP certification is a great achievement for Svar and underlines our strategy to be an expert partner to pharma companies by allowing us to provide QC services of the highest quality. We are committed to supporting our customers in their effort to meet the industry's increasingly strict controls and regulations and are delighted to be able to offer the flexibility of tailored solutions and provide QC testing services under GMP where required."
Svar launched its Bioanalytical Services in 2015 and has since provided GLP and GCP-compliant services for non-clinical and Phase I – III, including biosimilar and post-marketing clinical studies for pharma, CRO, and biotech clients worldwide.
The expansion of biologics testing capacity enables Svar to introduce GMP Potency testing to a wider circle of pharmaceutical customers, supporting lot release, stability studies, and in-process controls.
The GMP certification enables Svar Bioanalytical Services to offer its clients:
Qualification or validation of cell-based assays for potency measurements of the drug product and drug substance
Routine testing of drug product and drug substance samples in a GMP laboratory to support lot release, stability, and in-process analysis
Svar's dedicated GMP facility complies with the highest quality standards required by regulatory bodies and clients for testing drug products and drug substance samples. In addition to these services, Svar's potency testing experts offer tailored bioassay method development using the latest iLite® cell-based reporter gene assays.
Filiz Ibraimi, COO at Svar Life Science, said: "We are excited to expand our services to include GMP QC testing. This is a good strategic fit for our company as we continue to build our reputation as a trusted drug development partner, now ranging from early-stage discovery to commercial batch release. Having invested in best-in-class platforms and an experienced team of QC and Bioanalytical scientists, our services will bring great value to all our existing and future customers. We are dedicated to ensuring that the highest standards of quality and safety are met, thus providing peace of mind in the services we deliver.”