Formulation Development Approach
AI‑guided, DoE‑driven workflow that screens a 100‑excipient library to arrive at optimal formulations in weeks, not months.
The formulation development approach consists of two elements: a library of up to 100 different regulatory well-established and employed excipients and a rational development approach which employs statistical software and self-learning algorithms as well as state of the art design of experiment (DoE) matrices. By utilizing the artificial intelligence elements, Leukocare is able to specifically combine excipients leading to stabilizing formulations tailored to the drug product’s needs.
Step 1
Focus on TPP alignment, analytical transfer and a basic characterization of the drug substance to identify hotspots and main degradation pathways.
Step 2
Virtually unlimited design space by infinite excipient combinations
A.) Rational database-driven approach
Tailored pre-selection of excipients from Leukocare´s excipient database.
B.) Algorithm-based formulation selection
Applying state of the art Design of Experiment (DoE) matrices and software-based evaluation by linear and non-linear statistics.
C.) Iterative formulation optimization in subsequent accelerated aging studies
Leading to optimization of pre-selected formulations. Furthermore, no HTS is needed since our algorithms help to select the right combination of excipients in advance.
Step 3
Final optimization and identification
Final optimization and identification of best performing formulations in a confirmatory stability study
Step 3 encompasses a confirmatory stability study at relevant/target temperatures. Such a study is performed to optimize and identify the best performing formulations and to comply with regulatory requirements.
