Discussion Group Report  |
Biologics Analysis

Analytical Method Development for Biotherapeutics

By Tia Byer |
09 November 2021
Oxford Global’s Discussion Groups provide a focused networking opportunity for a handful of like-minded experts on a monthly basis. Our October Discussion Group addressing ‘Analytical Method Development for Biotherapeutics’ was a tremendous success. The discussion brought together an exclusive panel of key opinion leaders to address the key factors behind the market’s growth, its priorities, future outlook, and challenges.

Our October group came together for an hour of a specialist discussion about the analytical development for diverse biotherapeutic modalities. This discussion group was a select group of approximately 15-20 key industry leaders working in biotherapeutic and analytical development, representing key opinion leaders from pharmaceutical and biotech companies. The discussion was moderated by Amy Tam, Senior Principal Scientist at Pfizer, and panellists included Rachel Chen, Senior Scientist in Analytical Development at Biogen, and Galahad Deperalta, Senior Scientist at Genentech. The session was attended by senior representatives from AstraZeneca, Takeda, Immunocore, Blau Farmaceutica, and many more.

Amy Tam kicked off the discussion with a brief overview of how biotherapeutics as an exciting class of drug modalities have gained renewed attention within the past few years. During this, Tam delved into the various novel platforms and software that have become available for analytical development, touching on both their promise and the multiple challenges they pose. The summary also delved into future outlooks for the industry. Among its most interesting points touched upon was the possibility for advancements in biotherapeutic characterisation.

In particular, Tam spoke of the exciting developments in AI and ML for improved clinical observations and management, which she deemed “a rapidly growing field”. The opening overview also touched on the prospect of real-time release testing to optimise the evaluation of and ensure the quality of final biotherapeutics drug products.

After Amy’s introduction concluded, the debate began. Rachel Chen opened the floor to discuss the current high interest and industry trend of accelerating timelines during analytical development. Chen spoke about the various technologies available to streamline analytical workflow, such as digitising platforms and implementing post-translational modification procedures. She stated the importance of “early engagement via conducting research analytics during or even before RTD transition to ensure methodical transfer and significantly shorten the development timeline”. An interesting point raised was the cost and financial burden of accelerating the analytical development of biotherapeutics. A vital concern includes the possibility of wear-out behaviour whereby certain acceleration measures result in different elements of the drug candidate possibly ageing or becoming fatigued. This consequence inevitably undermines the efficiency of acceleration and leads to increased costs.

The panel continued with debate over in vitro and in vivo correlation and the extent to which the latter requires monitoring. Whilst some agreed that the importance and value of such correlations had been proven with specific Fc fusion proteins, where their circulation level is critical for clearance and PharmaKinetics, others disagreed. Chen pointed out how currently, for other modifications such as thymine oxidation and deamidation, there is little understanding about the value of in vitro and in vivo correlation. Fellow panellist Galahad Deperalta identified this as a particular interest and commented on how several members of his team at Genentech are working on in-vivo CQA mapping as a strategy to declassify the relationship. Deperalta described the need for CQA mapping as trying “to make the case that it isn’t critical due to the certainty of how post-translational modifications are affected by the human body”. He continued by arguing that this prior knowledge undermines the necessity of monitoring the in vitro and in vivo correlation. Deperalta also pointed out that “the question about whether the regulatory and health authorities accept this case is, however, another issue altogether”.

In response to the various hurdles posed by biotherapeutics optimisation, the discussion turned to future outlooks on automation technologies. For audience member Thomas Halder, R&D Manager Biopharma at Blau Farmaceutica, intuitive technologies are the way forward for ensuring both the efficiency and efficacy of biotherapeutic manufacturing. For Halder, “doing fewer things manually is a good idea if you want to end up with a working multi-attribute method solution”. He continued, by saying “to increase automation is to reduce the human error, and in doing so decrease the level of difference, you’re detecting”. Current trends include AI-based strategies to process large databases and screening programs to usher in quicker, cheaper, and more reliable drug discovery and development methods. Amy Tam attested to the promise of automated and computational technology, deeming them a “powerful vehicle in improving method development and validation of biotherapeutics”.

The discussion group concluded with some final thoughts on the future outlook of analytical development methods for biotherapeutics. With ongoing research and development and numerous exciting pipelines emerging in the field, the future looks bright for the biotherapeutics industry. At Oxford Global, we couldn’t have been more pleased with the turnout for our October biologics discussion group. The conversation was engaging, the debate stimulating, and the industry insights invaluable. We will continue our discussion group series this November to address Bispecific & Multi Specific Antibodies and Therapeutics. Learn more about the Oxford Global discussion group series at our Biologics Portal.

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