cGMP Aseptic Manufacturing And Sterile Fill-Finish

Source: Ascendia Pharma

Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.

Manufacturing must also consider parenteral injection types. Disposable/single-use-system injectable technologies provide alternatives to traditional compounding-filling in stainless steel or glass-lined vessels. The capabilities for single-use compounding-filling suites need to handle oxidation-prone compounds that are not compatible with traditional stainless-steel mixing vessels and transfer lines.

Ascendia manufactures sterile, injectable clinical trial materials in its Class 100 (ISO 5) clean room, and can also conduct aseptic processing.

Using isolator systems, Ascendia is able to minimize personnel involvement and separate the external cleanroom environment from the aseptic processing line. Ascendia also specializes in the production of sterile, dispersible dosage forms, including suspensions, nano-particles and nano-emulsions.

Injectable Formulation Development and Manufacturing

Ascendia Pharma has a proven track record in developing drug formulations for injectables. Implementing its BEST (Brilliant technology, Excellent service, Superior quality, and Trust) philosophy, the Ascendia team utilizes its proprietary nanotechnologies, cGMP manufacturing, and experienced scientists to meet your most difficult parenteral drug formulation challenges. Contact us today to see how we can become your Partner of Choice.