Contract testing laboratory Alphalyse has refined its biologic impurity analysis capabilities with a novel database.
The database, in combination with the company's analytical tools, aims to shorten the development time of advanced biologic therapies, while also improving their quality and regulatory compliance.
This announcement comes off the back of the US Pharmacopeia's guideline extensions, which highlights the best practices which should be employed when performing mass spectrometry (MS) analysis for the quality control of biologics.
According to Alphalyse, its refined method can be incorporated into biopharmaceutical projects in a few weeks, rather than the industry standard of one to two years.
The database, which contains a wide range of analytical MS results, can help biopharma companies to assess the risks associated with their biologic — ensuring that these can be mitigated to meet regulatory requirements.
Could MS become a requirement?
Currently, US Pharmacopeia guidelines state that MS is an important aspect in determining a biopharmaceutical's quality, and Alphalyse believes that it might become part of standardised procedure for developing biologics.
Lars Skriver, Senior Science Officer at Savara Pharmaceuticals, has worked on projects with Alphalyse, and believes that MS-based analysis of biologics "may become a regulatory requirement within a few years".
"Protein impurities are a great source of concern," he continues, "and regulatory authorities are focusing more on drug impurities than ever before."
"Many companies can perform protein analysis, but Alphalyse’s database provides an overview of which specific polluting agents you can anticipate in the production process of various biologics, and this is a major benefit."
As the traditional ELISA method can take more than a year to adapt to a novel drug, Alphalyse's MS tools and database could reduce a pharmaceutical's development time by several months, according to the company.]
"The industry has lacked access to a database like ours. We can now advise clients if and how often we have identified specific protein impurities and give them unprecedented insight into their product," notes Lars.
Considering MS for biologic testing
As pharmaceutical companies take increasing interest in biologics, quality assurance methods must be available to ensure as many effective drugs are making it to patients worldwide.
Through its services, Alphayse hopes to help pharmaceutical companies optimise the development and production of their biologic medicines — facilitating the cost- and time-efficient production of stable and safe drug products.
With the announcement of the new USP method chapter, Alphalyse hopes to strengthen its collaboration with existing and new clients, especially in the US, where the US Food and Drug Administration (FDA) frequently refers to the US Pharmacopeia.
Alphalyse's Thomas Kofoed concludes: "MS analysis can assist pharmaceutical comapnies in quality assurance, risk evaluation and procuction standardisation. It should lead to fewer drugs failing in clinical trials and more products reaching the market."
"By utilising this technology, we could see a growing number of innovative therapies reaching the market much faster than previously."
[Image credit: Alphalyse]