MANUFACTURE OF CLINICAL TRIAL MATERIALS
Ascendia offers a wide array of pharmaceutical science 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, an amorphous solid dispersion 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.
- Ascendia can manufacture cGMP batches for orally administered dosage forms – both tablets and capsules.
- We provide cGMP manufacture of sterile, injectable dosage forms for Phase I/II clinical studies.
- Ascendia maintains chambers to conduct stability testing in accordance with ICH guidelines.
- We provide the analytical method development and quality control testing services needed to advance your program.
- Ascendia can conduct formulation design and testing for tablet, capsule, parenteral, topical, and lyophilized dosage forms.
Our facility has a broad array of equipment needed to address most pharmaceutical projects, including an isolation hood for working with cytotoxic molecules.
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