GMP Production

GMP Production
Product Description

In 2017 piCHEM opened a brand new production facility providing 1.200m² edge-cutting laboratory and production space as well as adequate storage rooms. Peptides are manufactured in compliance with ICH guidelines and according to applicable laws and regulations. The production facilities are inspected and approved by the national authorities and the US FDA. Our pharmaceutical contract manufacturing department supports your drug development project through all stages of clinical trials. piCHEM conducts GMP manufacturing of APIs from milligram to several hundred gram scale. Peptides piCHEM offers peptide synthesis according to GMP with applicable techniques in peptide chemistry. Depending on the structure, quantity or special client requirements, different strategies are available, from conventional synthesis in solution to solid phase synthesis methods (SPPS). Reversed phase chromatography and ion exchange chromatography are applied as standard purification procedures for synthetic peptides. Peptides are available as lyophilisate in bulk or in bulk aliquots. For final manufacturing steps, cleanrooms in class D/C are available. Peptide-Protein Conjugates piCHEM has broad expertise in conjugation of peptides to carrier proteins like KLH, CRM-197 or BSA under GMP conditions. Conjugation manufacturing and purification processes strongly depend on the characteristics of the employed peptide and are designed individually. Peptide protein conjugates are manufactured in cleanrooms class D/C and are supplied as liquid or lyophilised bulk. Fill & Finish Services As a value-added service piCHEM provides aseptic fill & finish services in cooperation with qualified partners. Supporting GMP Services Supporting services include project management, process scale up and validation activities, analytical method development and validation, stability studies, generation of reference materials as well as regulatory services. Products supplied are released by a qualified person (QP) in full compliance with the EU GMP requirements (Eudralex Vol. 4 – Guidelines for good manufacturing practices for medicinal products for human and veterinary use).

piCHEM Forschungs- und Entwicklungs GmbH

  • AT
  • 2015
    On CPHI since

piCHEM Forschungs- und Entwicklungs GmbH

  • AT
  • 2015
    On CPHI since

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