The US Pharmacopeia will soon have a chapter on mass spectrometry- (MS) based analysis of biologics for impurity control in the biopharmaceuitcal industry.
On December 1, the chapter will be available in the US Pharmacopeia, providing biopharma developers with suitable guidelines for mass spectrometry-based quantification of host cell protein (HCP) impurities.
According to Alphalyse, MS can provide developers with detailed and informative data than the current widely used methods.
The chapter hopes to reduce the prevalence of unwanted side effects of biologics, allowing companies to create safe and high quality therapeutics.
Combatting host cell protein impurity
HCPs are impurities often found in biotherapeutic medicines such as vaccines, antibodies and gene therapies which need removing to ensure the drug's efficacy.
They have also previously been linked to side effects in patients, meaning that their removal is necessary.
Enzyme-linked immunosorbent assay (ELISA) analysis may not catch certain protein impurities, so regulatory authorities are cracking down on this issue by encouraging drug manufacturers to use mass spectrometry to control and document product impurities.
Senior Scientist with the US Pharmacopeia, Derrick Zhang, commented: "Mass spectrometry is now able to detect tiny amounts of impurities, so the US Pharmacopeia wanted to standardise its use in the industry."
Danish contract research organisation, Alphalyse, specialises in MS-based HCP analysis and has implemented many of the methods described in the novel USP chapter.
"We’re facing a breakthrough in the pharmaceutical industry. Mass spectrometry is a quick and effective method that can identify tens of thousands of different host cell proteins while detecting their respective amounts, allowing the targeted removal of harmful impurities in drugs." added Ejvind Mørtz, co-founder of Alphalyse A/S.
"This method is also suitable for complex products such as cell and gene therapies for the treatment of cancers, Alzheimer’s and genetic disorders. The recognition of mass spectrometry as a complementary method opens the door for us to support biopharmaceutical developers in getting their drugs approved for clinical trials and patient treatment."
Besides increasing biologic drug quality, mass spectrometry also offers a much faster development pathway than conventional methods. Process-specific ELISA analysis requires up to 24 months to develop, while an MS-based HCP analysis can be carried out in under three months.
"This means we can compare analytical results and use our experience across projects to help biologics developers improve their products. We hope the new method chapter from the USP will lead to increased knowledge and control of impurities across the industry, allowing companies to work together to make better, cleaner and safer drugs." concluded Mørtz.