Tech Transfer & Manufacturing Enhanced Services With 25 years of Fill-Finish experience, Pii's experts are uniquely qualified to take on complex formulations. Our GMP Certified facilities are integrated with our analytical, quality assurance, and fill-finish teams. Whether you are starting a clinical...
Aseptic Manufacturing and Sterile Fill-Finish is a process where a drug product, container, and closure are sterilized. Next, the sterilized products are moved to a cleanroom to combine the products. Self-contained equipment is typically used during this process....
Grand River Aseptic Manufacturing (GRAM) is a leading pharmaceutical contract development and manufacturing organization (CDMO) delivering quality solutions for our customer's clinical through commercial products. We provide fill-finish services for liquid vials, lyophilized vials, syringes and cartridges. ...
Complete engineering of fill-finish manufacturing facilities Technical facility due diligence Selection of suppliers and technology Qualification and validation of fill-finish facilities Ongoing site support after project completion to ensure a smooth production start-up ...
Outsourcing an aseptic fill and finish manufacturing process is a more sophisticated activity than prior to the publication of FDA'S aseptic processing guidelines in 2004. Expectations from biopharmaceutical companies are greater and aseptic contract manufacturing organizations have stepped up to meet the ...
Aseptic Filling ServicesCapacityFill Volume ManualUp to 900 vials/day50 ul-2 ml Semi-automatedUp to 2,000 vials/day1ml-100ml AutomatedUp to 4000 vials/batch0.5ml-6ml Regulatory Compliance Features Meets FDA requirements for Phase I/II/III clinical manufacturing ...
a leading Contract Development and Manufacturing Organization (CDMO) specializing in bringing molecules to clinic, has been granted a Good Manufacturing Practice (GMP) license by the Belgian Federal Agency for Medicines and Health Products (FAMHP) for its state-of-the-art aseptic fill-finish facility...
A medication container for a liquid vaccine can use plastic instead of glass thanks to ZAHORANSKY's advanced injection mold tooling and manufacturing equipment. This is accompanied - due to the eliminatio... Thermo Fisher Scientific's flexible aseptic manufacturing and sterile fill finish solutions fo...
Pharmaceutical manufacturing that provides biologic, small molecule, and vaccine capabilities for liquid and lyophilized vials, syringes, and cartridges.
The increased capabilities solidify Ardena's reputation as a trusted partner for drug development for clinical trials and complements Ardena's pre-existing strengths in drug substance development and manufacturing. Ardena's cutting-edge aseptic fill and finish plant in Ghent is equipped...