Contamination Detection Assays & Impurity/Residual Testing Services
From preclinical lots through routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of your biologic before it’s approved for use in animals and humans. The characterization of the purification process for the removal of impurities and testing for possible residues from process steps are also key parts of the chemistry and manufacturing controls (CMC) section of regulatory filings.
Viral Contamination Detection
Using High-throughput Sequencing (HIT)
HTS is an extremely sensitive test providing a broad range of detection for viral contamination of biological products.
Charles River's impurity testing services offer a portfolio of compendia assays for the detection of mycoplasma and bacterial contaminants and also in vivo, in vitro, and biochemical viral detection assays. Our experts can design and develop the appropriate contamination testing plan for your biologic, with a selection of available and customized assays that suit your specific needs. We support testing of all process stages for impurities, including residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin, and host cell proteins.
Charles River's Impurity Testing Offerings
- Microbiology Testing
- Mycoplasma Testing
- Sterility Testing
- Pyrogenicity, Endotoxin, and Monocyte Activation Testing
- Viral Safety Testing
- Next Generation Sequencing
- Host Cell Protein Assays
- Process- and Product-Related Impurities – HPLC-ELSD, HPLC-CAD, HPLC-MS, ELISA
- Residual DNA Testing
With a range of state-of-the-art equipment we provide thorough client-specific analysis of impurities and raw materials testing. Additionally, we offer transfer or method development and validation for customized, product-specific methods
Frequently Asked Questions (FAQs) About Contamination Testing
Why is contamination testing important?
Quality Control (QC) is essential to the pharmaceutical industry. Drug manufacturers must thoroughly test materials, processes, equipment, techniques, environments, and personnel in order to ensure their final products are consistent, safe, effective, predictable, and free of contaminants.
What is raw material testing?
Raw material testing refers to the purity, quality, and identity testing of all individual components of a product before it’s officially manufactures. Testing is conducted as described in the USP, EP, JP, etc., and ensures that any of the components used in the production and manufacture of pharmaceutical products are suitable for their intended use.
Where can biologics contamination testing regulatory guidelines be found?
Here are some regulatory guidelines for ensuring the safety of your products: