Regulators are placing greater demands on pharmaceutical companies to ensure safety and efficacy of their products. We understand the challenges pharmaceutical companies face and are committed to helping our clients ensure compliance with regulations and standards. Our innovative in vitro drug discovery services alongside our human tissue models are designed to help pharmaceutical companies determine biomechanistic endpoints, drive formulations towards clinical trials and re-evaluate shelved items for the market.
ImmuONE was engaged by a pharmaceutical company with a pioneering antibody-drug conjugate (ADC) – a unique medicine engineered to selectively target cancer cells with potent chemotherapy agents. The ADC’s innovative feature was its inhaled delivery system, which provided distinct advantages, such as localised drug delivery, enhanced effectiveness, reduced systemic toxicity, and improved patient adherence. However, this novel approach presented several challenges that required careful consideration: potential lung toxicity, ensuring target specificity, precise dosage control, and adherence to regulatory compliance.
(Figure 1) – Illustration of a collaboration with ImmuONE that followed a structured timeline, focused on addressing the client’s research objectives and compliance needs.
What We Proposed
After holding discussions with the pharmaceutical company to understand their objectives and concerns, ImmuONE proposed an in vitro drug discovery service as a more accurate and efficient alternative to preclinical animal studies.
ImmuONE tailored a scope of work that precisely addressed the company’s primary safety concerns. The focus was on assessing off-target toxicity, cytokine release, and the uptake of the ADC into macrophages and epithelial cells.
Utilising our in vitro human models via the tailored services, we provided fast and relevant results compared to traditional animal testing, a process which would typically have taken several months longer.
(Figure 2) – Exploring immune responses and interactions of formulations for drug discovery and development.
By adopting ImmuONE’s in vitro approach, the pharmaceutical company benefited from more accurate data, reduced variability, and faster turnaround times, supporting their research and development efforts with greater efficiency and precision.
About ImmuONE’s drug discovery testing services
In the realm of inhaled drug delivery, ensuring the safety and efficacy of formulations is critical, but conventional animal studies pose challenges such as time consumption, cost, and limited predictability of human responses. These limitations can lead to delays in drug development and potential risks to patients.
ImmuONE offers cutting-edge drug discovery testing services tailored to the pharmaceutical industry’s needs, providing a reliable and efficient solution to these challenges: