Delegates and speakers at the DiPIA meeting agreed that the use of label-free approaches is now more frequent in discovery of biotherapies and vaccines. However, techniques such as SPR have also shown promise in improving many downstream analytical tests, including ADME/Tox screening, bioprocessing, and QC applications.
According to Dr. Maasch, Noxxon plans “to use SPR later in development work such as pharmacokinetic analysis using an anti-PEG antibody to track Spiegelmers. As Spiegelmers are pegylated, this will require less assay development time if we use SPR.”
Many academic groups have been able to link bioreactors to SPR methods to provide real-time analysis of mAb production and this could be used in pharmaceutical manufacturing.
“To ensure that Biacore instruments could make the transition from being analytical lab machines to being used in a GMP environment, we have a clear link between paper and electronic records. We also have trained personnel that will help to document everything—because the FDA’s view is unless it’s documented it never happened. SPR assays are already being used in batch-release applications by some biopharma companies. We expect that over the next few years other companies will follow and start implementation of label-free assays in this key area,” Sundberg said.
SPR assays are already being used in batch-release applications by some biopharma companies. We expect that over the next few years other companies will follow and start implementation of label-free assays in this key area,” Sundberg added.
In short, label-free technologies are going from strong to stronger in the development and manufacture of biotherapies and vaccines. “When the pharmas and biotechs start trying to gain approval for their biosimilar products, multiple independent technologies such as SPR, ITC, ELISA, and LC/MS, will provide a sea of protein data.
“If the biosimilar is very well characterized and its protein profile compares well with the existing antibody or protein therapy, then regulatory authorities may allow the company to perform smaller numbers of clinical trials to get their biotherapeutics to market. This could significantly reduce the clinical development costs of the therapy and is a good reason to characterize a biosimilar very thoroughly,” Sundberg concluded.