Better assay methods to permit process monitoring and product characterization will enable more biosimilar approvals. FDA
and other regulatory agencies will largely rely on analytical data to support conclusions that biosimilar candidates are sufficiently
similar to their marketed reference products to allow generic-like approvals. As such, regulators are likely to look for better
analytic characterization through more combinations of attributes at greater sensitivities with multiple complementary methods.
For drug developers, analytical method development and testing will be less expensive and quicker compared to reliance on
clinical trials to support approvals.
Figure 2: Select new product-development areas of interest (data, reference 1).
Progress in the development of bioprocessing-related assays and analytical equipment, however, has not kept up with industry
demands. Better analytical technologies are being sought by the industry for improving productivity, process monitoring, real-time
product quality control, process optimization, and analytical characterization for biosimilars. These trends are reflected
in a recent BioPlan Associates survey, where more than 32% of biopharmaceutical manufactures and 21% of CMOs expressed demands
for improved analytical assays (see Figure 2). The survey showed that, after single-use/disposable bioprocessing equipment,
more relevant and cost-effective assays and analytical equipment are strong needs. Areas of interest include better probes
and sensors, in-house real-time analyses of process streams, use of biological assays to determine active agent-related quality
(e.g., glycosylation variants), and outsourcing of specialized chemical analysis and biological assays.
Figure 3: Percentage of all biopharmaceutical Industry vendors actively funding assay-related R&D (data, reference 1).
More than one quarter (26.2%) of respondents cited analytical testing and drug-product releases a major factor likely to constrain
their organization's production capacity during the next five years. Respondents identified 26 areas where new and improved
testing technologies are required. More than 40%, cited glycosylation and comparability testing (primarily for demonstration
of comparability between lots/batches of the "same" product, but also to show similarly for biosimilar products). Also, nearly
40% of all respondents cited the need for better host-cell protein assays, biophysical characterization during process development,
and in-process testing and aggregation assays. Figure 3 shows the percentage of vendors funding assay-related R&D.
Eric Langer is president and managing partner at BioPlan Associates and a member of BioPharm International's editorial advisory board.
1. BioPlan Associates, "8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: Survey of
Biotherapeutic Developers and Contract Manufacturing Organizations" (Rockville, MD, April 2011).
2. BioPlan Associates, "Biopharmaceutical Expression Systems and Genetic Engineering Technology: Current and Future Manufacturing
Platforms" (Rockville, MD, 2008).