The biotherapeutic QC testing department at AcuraBio is responsible for the sampling, management, and testing of a wide range of materials including raw materials, in-process samples, drug substance samples, drug product samples, stability samples, and environmental monitoring samples.
AcuraBio’s QC staff are highly trained in state-of-the-art analytical techniques.
Our analytical capabilities include:
- Protein Biochemical Analysis
ELISA Testing Service (incl. fluorescence detection)
Host Cell Protein Testing
Fluorescence/Luminescence/Absorbance spectrophotometry
SDS PAGE/Western Blot
- Chemical and Physicochemical Techniques
HPLC (UV/PDA/ELSD)
UV/VIS spectrophotometry
- Anaerobic and Aerobic Bacterial Culture and Analysis
Microscopy (Including Fluorescence – Live/Dead analysis)
- Environment Monitoring
Endotoxin
Total Organic Carbon (TOC)
The Quality Control Leaders
AcuraBio’s QC department performs two distinct functions:
- Chemical, Biochemical, and Microbial analysis
- This includes raw material testing, in-process/intermediate control testing, API/drug substance testing, drug product testing, and stability testing, as well as environmental monitoring testing
- Transfer, Development, and Process Validation of analytical methods
- These processes ensure efficient transfer of analytical methods and setup of new methods to support our client’s projects
