Biopharmaceutical Process and Product Related Impurities Analysis

During the drug development process, unknowns often arise from impurities and degradation products that can be formed during the manufacturing process or storage of the new drug. Current United States Food and Drug Administration (USFDA) regulatory guidance requires that studies be conducted to identify the impurities present in a new drug substanceand to characterize their structure.

A well-characterized biopharmaceutical is defined during its development by identification and quantification of both process and product related impurities. Product-related impurities in the drug substance are molecular variants with properties different from those of the desired product formed during manufacture and storage. Creative BioMart has built a strong track record analyzing product related impurities and detailed analysis of product variants.

Content, purity and impurity profile

Protein content: protein assay (Kjeldahl, Lowry, Bradford), absorbance at 280 or 230 nm, HPLC, SDS-PAGE

Purity: HPLC, RP-HPLC, GF-HPLC, HPLC (IE), HPLC (HI), CE, SDS-PAGE

Impurities (process-derived):

• Mycoplasma Detection System
• DNA - threshold, RT-PCR
• Host protein - ELISA
• Leachates - HPLC, gas chromatography
• Protein A - ELISA
• Cell culture components - ELISA
• Antibiotics - etc
• Other residuals - IPTG, Triton-X, antifoaming agents and surfactants, Tween/Polysorbate, DCA, TCEP, inorganic anions/ cations, heavy metals, solvents, enzymes

Impurities (product-derived):

• Aggregates, subunits, fragments, truncation -SE-HPLC, SDS-PAGE
• Oxidized - RP-HPLC, peptide mapping
• Deamidated -RP-HPLC, test kit
• N-terminal cyclisation - peptide mapping, LC-MS, Edman degradation
• Phosphorylation, sulphation - IEF, IE-HPLC, peptide mapping

Our client portfolio includes large, small and virtual pharmaceutical companies who have benefited from our attention to detail and dedication in getting results to them right on time, every time.

To find out more details about our services, contact us today.