Intertek ASG Laboratory, Manchester, UK

Biopharmaceuticals:

Process and Product Related Impurity Analysis

A well-characterized biopharmaceutical product is defined during its development by identification and quantification, if possible, of both process-related and product-related impurities. Process and product related impurity testing can be used to show purity, batch to batch consistency and where certain impurities are removed during the process.

Intertek ASG offers highly sensitive analytical solutions to enable detection and measurement of process related impurities at very low levels and detailed analyses of product variants.

Process related impurity analysis

Recent studies have included isolation and detection of process related impurities including host cell proteins, inducers (IPTG), antibiotics (kanamycin, chloramphenicol), and those related to downstream processing (dithiothreitol, DCA, heavy metals and TCEP) from diverse matrices. This has been achieved using a range of in-house analytical techniques and instrumentation including GCMS, HPLC with UV detection, LCMS/LCMSMS, NMR, ICP-MS and UV assay.

Intertek ASG is highly experienced in the development, verification and validation of methods for process related
impurity analysis, in accordance with ICH Guidelines Sections Q2(R1) and Q6B. All work is subjected to internal QA audit/review upon request and is performed by technique experts in a GLP/cGMP accredited laboratory using state of the art, qualified instrumentation.

Product related impurity analysis

Intertek ASG has built a strong track record analyzing product related impurities relating to proteins, peptides and oligonucleotides. Product related impurities have been characterized and quantified using an array of separation techniques including ion exchange, size exclusion and reverse phase chromatography. The high specificity and sensitivity of UV and mass spectrometer detectors has allowed for detailed characterization and quantitation of low level impurities.