Hyderabad-based Hetero Biopharma has embarked on a working relationship with Transcell and Quantiphi to explore the integration of the Digital Animal Replacement Technology (DART) into its operational processes. Transcell and US-based Quantiphi have collaboratively developed an innovative solution known as DART which harnesses human Microphysiological Systems and employs artificial intelligence (AI) 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 stage. 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. DART is one of the fascinating areas that the Hyderabad-based startup Transcell is working on with an aim to replace the need for live animal testing in parts of the drug and vaccine development and manufacturing process.

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