Background: In biopharmaceutical production, antibiotics and other drug residues may be introduced intentionally or unintentionally during upstream processes, particularly for:
– Selection pressure in genetically engineered cells
– Contamination control in fermentation or cell culture
– Additive components in media or stabilizers
These residues must be minimized and monitored as they can pose regulatory, safety, and efficacy risks in the final product. ELISA is the quickest and most convenient method to estimate the same.
EMA
EMEA/CVMP/837/99 – Residue limits in cell culture products
Case-by-case; based on safety assessment
FDA
21 CFR 211.165, 21 CFR 610.13 – Residual testing for biologics and parenterals
Generally requires LOQ < 1 ppm ICH ICH Q3A/B – Impurities in New Drug Substances and Products Sets risk-based impurity thresholds The KRIBIOLISA Bioprocess Assay Kits available enable researchers to estimate and measure the amount of residual analyte left post downstream purification process. These assays can help identify or characterize the residual analyte which is important in early process and final product release. This Assay kit is designed to facilitate the identification and characterization of bioprocess analytes used in production and purification. Assay Features include: – Ready to use protocol with pre-coated breakapart wells for ease of use – Standardisation and High Reproducibility – Lot to Lot Consistency – Accuracy and Precision Validated against seven points for a Gold Ring Standard Quality – the benchmark sign for Krishgen quality. The kits are used for assessing the specific biomarker in samples analyte which may be cell culture supernatant and other biological preparations. Unlike competitor assays available, we offer pre-coated ready-to-use assays to ensure high level of reproducibility and accuracy and also offer custom assay development which is process specific to comply with FDA needs from our ISO13485 certified factory and labs.
