Manufacturing

MANUFACTURE OF CLINICAL TRIAL MATERIALS

Ascendia offers a wide array of pharmaceutical development capabilities for manufacturing and analyzing drug product dosage forms. We specialize in providing contract manufacturing services to emerging and specialty pharma companies that need expertise to outsource manufacture and release of small scale clinical batches.

Whether the program is for a novel injectable product, a tablet or capsule for oral administration, or topical delivery of a poorly water soluble drug, Ascendia can be your manufacturing partner. We are rapid, comprehensive and flexible with our clients - work with Ascendia to access efficient advancement of your drug development project to first-in-man clinical testing.

ORAL DOSAGE FORMS

Ascendia can manufacture cGMP batches for orally administered dosage forms - both tablets and capsules within our Class 100,000 suites.

PARENTERAL DOSAGE FORMS

We provide cGMP manufacture of sterile, injectable dosage forms for Phase I/II clinical studies with our Class 10,000 (ISO 7) through Class 100 (ISO 5) clean rooms, and Class 100 biological-safe laminar flow hood. We are capable of conducting both aseptic or terminal sterilization.

STABILITY STUDIES

Ascendia maintains ICH stability chambers to conduct stability testing in accordance with ICH guidelines.

 

ANALYTICAL SCIENCES

We provide the analytical method development/validation and quality control testing and release services needed to advance your program compliant to cGMP regulations.

 

DOSAGE FORM DEVELOPMENT

Ascendia can conduct formulation design and testing for tablet, capsule, parenteral, topical, and lyophilized dosage forms.

 

FACILITY & EQUIPMENT

Our facility has a broad array of equipment needed to address most pharmaceutical projects, including an isolation hood for working with cytotoxic molecules.
Sign Up Now For Updates