One standout aspect of DART is its seamless integration into existing workflows, enhancing end-user engagement
The FDA Modernisation Act 2.0 marks a pivotal moment in reshaping the global pharma and biopharmaceutical industry. Additionally, the Indian DCGI has granted authorization for the use of alternative methods to animal testing, such as cell-based assays and computer models. In alignment with this trend, Transcell and Quantiphi have collaboratively developed an innovative solution known as Digital Animal Replacement Technology (DART).
This advancement harnesses human microphysiological systems and employs artificial intelligence and machine learning-powered digital prediction models. These models are integrated into modular assays that predict safety and efficacy concerns of pharmaceuticals and biopharmaceuticals intended for human use. One standout aspect of DART is its seamless integration into existing workflows, enhancing end-user engagement. This empowers users to assess the safety and efficacy of their assets, providing human-relevant data even before clinical trials commence and sometimes during routine batch testing stages.
Within the developmental cycle of biosimilars, a strategic approach involves a progressive evaluation of biosimilarity and efficacy equivalence. This includes the consideration of conducting animal studies when necessary and appropriate, based on remaining uncertainties. This approach aims to efficiently tailor study requirements.
Hetero Biopharma has embarked on a working relationship with Transcell and Quantiphi to explore the integration of the DART advanced technology into its operational processes.
“We have started working with Hetero Biopharma’s young and dynamic leadership team in offering some of the non-animal DART residing modules for human cardiotoxicity and immunogenicity like key assessments. We are sure to add value in supporting their routine testing requirements within their processes and workflow – Advantage in adopting DART, which is anti-thesis to contract testing model”, says Dr S Dravida, Founder & CEO, Transcell group representing DART implementation opportunity.
Dr Bala Reddy, Director, Hetero Biopharma said, “Evaluating the value of animal studies to support regulatory approval of biosimilars is becoming more and more important. In light of guidelines from various regulatory agencies that encourage alternative approaches to animal testing, innovative technologies like Transcell’s human microphysiological systems in combination with AI & ML-based in-silico modeling, provide opportunities to develop better and more predictive scientific tools to safeguard the environment and the health of both humans and animals.”
Asif Hasan, Co-founder, Quantiphi shared “DART embodies our unwavering commitment to propel bio/pharmaceutical research and development with the utmost ethical standards. Employing ethically sourced human stem cells, a sophisticated digital workstation, and the prowess of artificial intelligence (AI), DART forecasts drug safety, efficacy by analysing human microphysiological systems -drug interactions. DART upholds our vision of sustainable drug discovery, development while maintaining a steadfast focus on ensuring both safety and efficacy.”
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