Biosynth’s site in Lelystad, The Netherlands, has successfully passed the recent GMP inspection by the Inspectie Gezondheidszorg en Jeugd (IGJ) on January 25, 2023. The scope of the inspection was the Quality Management System of the site.
The inspection, carried out by the IGJ confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no major or critical observations were issued.
At the closing meeting, the inspectors stated that the site is working at or above the average level of API manufacturers. They were highly satisfied with what they had seen and complemented Biosynth on its GMP system, inspection organisation and the knowledge and commitment of its team members.
Our stronghold in small and medium scale NCE’s and patient-centred approaches means we are continually improving
Ehab Alramahy, Head of the Peptide Division, said on the inspection's outcome: “We are very proud of the results achieved during this inspection. I am delighted that the IGJ inspectors reported no major or critical observations, which clearly shows the commitment of our entire team to quality and patient safety. This is another important milestone for our site in Lelystad and the Peptide Division overall, as it confirms our ability to support our customers throughout the entire lifecycle - from research to commercial supply of peptides.”
Hans de Backer, Head of Peptides Operations, added: “It is a great confirmation that our customer-focus and emphasis on timely delivery goes hand in hand with complying to the highest engineering, manufacturing and quality standards for the supply of peptides. Our stronghold in small and medium scale NCE’s and patient-centred approaches means we are continually improving and expanding the range of projects on which we work.”
Biosynth’s Peptide Division is building on 40 years of experience in advancing and applying peptide expertise to facilitate customers in developing and producing peptides. Biosynth is a one-stop shop for peptide products and services. From custom peptide synthesis and libraries, lead discovery and optimisation, large-scale peptide manufacture and GMP-compliant NCEs, as well as class-leading neoantigen peptide programs.
