CDMO Analytical Services
Ology Bio’s Analytical Services in the Quality Control (QC) laboratories are supported by analysts and scientists with 50+ years cumulative experience.
Analytical services include:
- Method Transfer
- Method Development
- Method Validation
Methods employed for in-process batch release and stability testing will be validated or verified as required by the applicable regulations and Guidances, to a level appropriate for the development stage of the product. Methods in early development phase will be subjected to a limited validation exercise that demonstrates that the method is scientifically sound (specific, sensitive, and accurate), but may not evaluate robustness or ruggedness as described in ‘Guidance for Industry: CGMP for Phase 1 Investigational Drugs’ – July 2008. Protocols and reports will be written by Subject Matter Experts (SMEs) for all development and validation related studies. Development and validation studies will be performed by experienced and trained individuals of Ology Bio QC department.
QC laboratories include Microbiology, Analytical Chemistry, Cell Assay and Stability laboratories. QC is controlled by a series of SOPs which specifically apply to operations that are unique to QC laboratories.
Ology Bio’s Analytical Services support the transfer, development, and validation of standard, as well as customized, methods necessary to characterize and release pharmaceutical and biologic products. Our team’s experience and flexibility in phase appropriate development ensures timely and efficient drug development.
- Release assays
- In-process testing methods
- Characterization assays
- Assay transfer and assessment
- Product characterization
- Process development support