Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC

Biopharmaceutical manufacturers are seeking to expedite the process of taking multi-attribute methodology (MAM) from the development to the quality control (QC) arena and are working with analytics providers and government agencies to help address the challenges involved.

Having shown the effectiveness of the mass spectrometry-based MAM in improving biomolecule characterization, design and development, the push is on to achieve MAM’s potential for reducing the number of assays needed for QC release while increasing the power of the results.

A consortium has been organized to bring the experts in the field together to benchmark on the advancement of MAM in process and product development, and to collaborate on leveraging this advancement to realize its potential in streamlining QC release.

The goal is to strengthen the communication process around the methodology between industry and regulators so that the data can be presented in a common way that makes it most compelling in the context of the individual molecule evaluations.

The MAM consortium participants include: ● the biopharmaceutical companies Amgen, Genentech, Biogen, MedImmune, Pfizer, Just and Regeneron ● equipment and software providers Thermo Scientific, Waters, Agilent, Fujifilm, SCIEX, Genedata, and Protein Metrics, and ● the National Institute of Standards and Technology (NIST) and FDA.

The consortium has been meeting via telecon. The meetings include a presentation by one of the participants followed by discussion.

During 2017, in collaboration with NIST, the consortium is embarking on what is referred to as a “new peak detection round robin.” A monoclonal antibody supplied by NIST will be evaluated by companies and vendors to shed light on how well-synchronized companies and vendors are in the MAM-related analytics and new peak detection.

FDA Office of Pharmaceutical Quality’s New Technology Team, which is helping steer manufacturing and control innovation through the development and regulatory review process, has also been actively consulting directly with new product sponsors on MAM.

The methodology has been a key focus of the team’s attention in the analytics arena – complementing its focus on continuous manufacturing (CM). MAM, in turn, has a significant role to play for CM in the biopharmaceutical area.

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