Laurus Labs, in line with evolving regulatory expectations in the pharmaceutical industry, actively incorporates Quality by Design (QbD) principles into its product development processes. As part of this commitment, the company regularly employs Design of Experiments (DoE) using MODDE® software. This methodology helps in comprehending the multidimensional effects and interactions of input factors on the output responses of pharmaceutical products and analytical methods.

In addition to DoE, Laurus Labs utilizes various software and simulation tools to enhance its development processes. These include Dissolution software, Sarah-Nexus for mutagenicity prediction, and Mirabilis for purge-factor calculation. These tools contribute to a thorough and systematic approach in ensuring the quality and reliability of pharmaceutical products and analytical methods throughout the development lifecycle.

Complementing the analytical infrastructure of Active Pharmaceutical Ingredients (APIs), Laurus's formulation analytical labs boast a comprehensive range of techniques readily accessible through Electronic Lab Notebooks (ELNs). These resources cover the entire spectrum from prototype formulation development to pilot-bio batch manufacture and beyond.

In addition to standard High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) equipment with multiple makes and models, including various detectors, the Formulation Analytical Development (FDF-AD) labs at Laurus are equipped with a full suite of wet-analysis equipment. Furthermore, these labs have access to specialty equipment such as Liquid Chromatography-Mass Spectrometry (LCMS), Gas Chromatography-Mass Spectrometry (GCMS), LCMS/MS, Nuclear Magnetic Resonance (NMR), High-Resolution Powder X-ray Diffraction (PXRD), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Ion Chromatograph, Malvern Particle Analyzers, Differential Scanning Calorimetry (DSC), Thermo-Gravimetric Analysis (TGA), Scanning Electron Microscope (SEM), Optical Microscope, and Zetasizer (Dynamic Light Scattering), alongside essential in-silico and software tools.

This extensive array of analytical tools ensures a robust and comprehensive approach to quality control and characterization throughout the formulation development and manufacturing processes at Laurus Labs.

Solidifying its position as a forward integration-capable Active Pharmaceutical Ingredient (API) developer and manufacturer, Laurus Labs has ventured into the development of Injectable finished dosages. This expansion includes the formulation of various potent oncology APIs. Notably, there is a heightened emphasis on the development of Long-Acting Injectables (LAIs), which have gained regulatory preference for delivering Anti-retrovirals in specific patient populations. This strategic move demonstrates Laurus's commitment to diversifying its portfolio and addressing evolving healthcare needs.

Although technically an oral formulation, Orally Disintegrating Films (ODFs) have garnered significant attention as a novel delivery aid, particularly when delivery via lingual and buccal routes is desirable and beneficial. At Laurus Labs, dedicated teams of scientists in the ODF lab have successfully developed a novel ODF formulation, specifically for a pediatric Anti-Retroviral (ARV) indication. This achievement is noteworthy as it reflects Laurus's commitment to innovation and responsiveness to healthcare needs, particularly in pediatric medicine. Additionally, the approval received for this ODF formulation underscores its efficacy and regulatory compliance.