Development and validation of activity- and stability-indicating biosensors for the quality control of bio-therapeutics

Medhat Al-Ghobashy, PhD

Lecturer of Bio-analytical Chemistry Vice-director of Biotechnology Centre Faculty of Pharmacy, Cairo University

Background: Biologicals are inherently more complex and sensitive to environmental conditions than small-molecule drugs. They have a highly ordered structure that determines both activity and safety. The impact of any change in structure during the upstream, downstream processing or formulation on therapeutic efficacy and safety should be thoroughly evaluated. Bioassays are considered the gold standard for evaluation of the activity of bio-therapeutics. However, from a pure industry point of view, bioassays are time consuming and are not production-friendly techniques. Since the launch of the Process Analytical Technology (PAT) initiative by the US Food and Drug Administration (FDA) in 2003, PAT was introduced as a concept in GMP-based bioproduction. The main objective was to improve process knowledge via continuous monitoring without affecting product quality. Many tools based on advanced sensing techniques, biosensors and model based software sensors are being trialled. To achieve this objective, modular systems are necessary to improve the robustness of biosensors and integrate them with various production steps. Aim: Development of an automated / semi-automated biosensor platform that indicate activity and stability of biotherapeutics throughout various production steps. Such biosensor will be as reliable as the bioassay but of less variability, high throughput, more economic and capable for continuous monitoring. All methods should comply with the international guidelines of The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), WHO and FDA for testing of biological products.
Outcomes: 1- Establishment of high throughput technologies for continuous monitoring of biotherapeutics. 2- Building in-house capabilities for monitoring the quality of biotherapeutics. 3- Efficient industry-academia partnership that boosts the national biopharma industry.