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Accelerating your path, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful BLA and marketing applications.
Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies.
Our in-house analytical approach focuses on qualifying phase appropriate assays for a spectrum of testing including: safety, potency, purity, identity, and extended characterization that enable end-to-end support for:
Our Capabilities
Stability
Offering a full spectrum of services, we support stability studies for drug substance, drug product and in-use testing per ICH guidelines.
Stability indicating assays are identified early on via forced degradation studies performed during process development.
Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.
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