The National Institute of Standards and Technology (NIST) first created NISTmAb (a standardised monoclonal antibody) in 2016 as a reference tool for biopharmaceutical companies looking to develop their own mAb therapies.
Building on this work, NIST has now made public the steps it took to produce versions of NISTmAb that closely resemble the characteristics of the original reference protein – effectively providing a blueprint for companies to emulate the process necessary to meet the standards required for cell culture and biomanufacturing.
A spokesperson for NIST stated that revealing its process “provides an opportunity to link cell culture and biomanufacturing measurements directly with analytical measurements of product quality.”
The spokesperson continued: “Standardisation of the bioprocess can in principle lead to more consistent manufacturing practices and outcomes. It can also provide a material that can be used for pre-competitive innovation in bioprocess techniques and controls.”
How these could provide companies with a competitive advantage was referenced in the original press release from NIST, which stated that use of the standardised cell line production and the original NISTmAb would allow for companies to ‘benchmark’ their technologies, such as biosimilars, against the originator product. Further suggesting that this could be used as a tool by companies to take their products in front of regulators to prove “efficacy, quality and safety”.
“The use of cell lines could underpin or support new manufacturing process development and downstream purification methods by providing a common platform through which new technologies can be benchmarked”, explained the spokesperson.
With the US Food and Drug Administration recently releasing its Biosimilar Action Plan, the Agency is working to encourage the number of biosimilars in development.
This aim dovetails with the researchers at NIST making its findings to improve mAb production available for public domain research, which could then be used to benchmark production quality in front of the Agency itself.