Formulation and Sterile Manufacturing Capabilities
Ensuring your drug substance is developed into a successful drug product while meeting the regulatory and clinical trial requirements can be one of the most difficult and complex challenges of your drug development process. Aptuit can help to solve these challenges.
Our expertise focuses on the rapid development of parenteral formulations and GMP sterile manufacture of drug products for clinical study supply (both small organic molecules and biological formulations).
Our formulation capabilities include:
• Specific tools and expertise in developing and transferring lyophilised formulations
• Analytical development covering method development, transfer, validation and short term ICH stability studies.
Our manufacturing capabilities include:
• Clean room suites dedicated to either non-cytotoxic or cytotoxic products
• Each suite capable of liquid fill or lyophilised product manufacture in dedicated lyophilisers
• Batch sizes up to 2500 vials per manufacture
• Media fill process qualifies a wide range of container sizes from 2 mL to 100 mL vials.
• Product labeling conducted onsite or via wider Aptuit network
Our QC/microbiology capabilities include:
• HPLC, FTIR, UV, Karl Fisher are among the standard QC techniques
• Endotoxin, sterility & sub-visible particulate testing
• ICH stability studies conducted on site
Our sites are inspected and licensed by the MHRA, have an Investigational Medicinal Products License, and operate to EU GMP. Products are routinely manufactured for global studies. Qualified Person (QP) services are provided on site.
For more information on any of these services, please contact us.