In alignment with the dynamic regulatory expectations placed on pharmaceutical organizations to incorporate Quality by Design (QbD) principles into product development, Laurus Labs consistently utilizes Design of Experiments (DoE) through MODDE® software. This approach allows us to comprehensively grasp the multidimensional effects and interactions of input factors on the output responses of pharmaceutical products and analytical methods. Beyond DoE, we employ various software and simulation tools as integral parts of our development process. For instance, Sarah-Nexus is employed for mutagenicity prediction, while Mirabilis is utilized for purge-factor calculations. These tools play a crucial role in enhancing the precision and efficiency of our development endeavors.

Laurus analytical development labs are a chemists dream with every conceivable technique available in-house & at a click from their ELNs enabling a near absolute characterization of the compounds & finger-printing of the processes. Apart from HPLCs; GCs across multiple makes & models with a choice of detectors; and all required wet-analysis equipment, the AD labs in Laurus have specialty equipment like LCMS, GCMS, LCMS/MS; NMR; High Resolution PXRD; ICP-MS; Ion-Chromatograph; Malvern Particle Analyzers; DSC, TGA, SEM, Optical Microscope; Zetasizer and not to forget insilico/ software tools such as Sarah-Nexus, Mirabilis etc. 

Overall, it can be safely claimed that at Laurus we almost never require third-party analytical services and this makes a great impact on our speed of development.

Laurus R&D is equipped with dedicated suites designed for the development of potent and high-potent moieties, particularly for oncology drugs. These suites ensure complete isolation in compliance with occupational safety standards. The engineering controls incorporated in these potent suites enable us to handle compounds with an Occupational Exposure Band (OEB) of 1ug/m3 TWA 8Hrs, ensuring a high level of safety. Consistent with our other development assets, Laurus possesses seamless scale-up capability, facilitated by our multi-site dedicated potent manufacturing blocks located in Visakhapatnam. This integrated approach allows us to effectively and safely advance the development of pharmaceutical compounds, particularly those with high potency.

The selection of an appropriate separation technique during the development stage plays a pivotal role in determining the cost-effectiveness and commercial viability of a project. Laurus R&D boasts comprehensive small-molecule chromatographic separation capabilities, supported by complementary assets at commercial scale. These capabilities include:

Conventional column chromatography (Normal phase) capability laboratory, pilot-scale Preparatory column chromatography (reverse-phase) of multiple lab-scales to pilot scale Pilot scale Simulated Moving Bed-SMB also called Multi Column Chromatography-MCC (Novasep Varicol) Pilot-scale Super Critical Fluid Chromatography (SFC) setup. Ultrafiltration systems at the development stage, utilizing equipment such as Sartorius Stedim. Centrifugal Partition Chromatography (CPC) facilities at both lab and pilot-scale, employing ROTACHROM rCPC.
In addition to our capabilities for large-scale chiral separations, we routinely engage in the development of enantioselective/asymmetric synthesis. Leveraging our strength in chiral ligand-based induction of asymmetry, we effectively eliminate the need for chiral resolutions and separations. This integrated approach positions us to deliver efficient and cost-effective solutions in separation science.

Since its inception, Laurus Labs has maintained a dedicated team of highly qualified scientists specializing in solid-state chemistry and small-molecule crystallography. Their expertise, coupled with the competence of our process engineering team, positions us to offer robust lab-scale support for polymorph, salt screening, stable morph identification, process design, and manufacture. This team receives comprehensive support from a range of advanced analytical instrumentation. High-resolution PXRD (PANalytical) stands out, allowing in-situ observation of solid form development. Additional ancillary equipment, including DSC, TGA, NMR, DVS, SEM, optical microscopy, and IR, further enhances our capabilities in solid-state chemistry and small-molecule crystallography. This integrated approach ensures the thorough exploration and understanding of solid forms, contributing to effective process development and manufacturing.

The process engineering group at Laurus Labs, comprising a team of chemical engineers, collaborates closely with process scientists to formulate fail-safe, scale-up processes, especially focusing on aspects such as reaction kinetics, fluid dynamics, and crystal formation. Our engineering labs are fully equipped with cutting-edge assets, including Optimax synthesis workstations that facilitate process parameter studies, along with tools such as FBRM (Focused Beam Reflectance Measurement), PVM-Online Microscope (MT), and VisiMix software. This integrated approach ensures a comprehensive understanding and optimization of processes, contributing to efficient and reliable scale-up in our operations.

Each process developed at our R&D, whether it involves API, intermediates, starting materials, or any other required processes, is accompanied by a comprehensive process safety report. These reports play a crucial role in enabling manufacturing operations to design large-scale processes that prioritize safety. Our process safety team, consisting of both engineers and chemists, meticulously evaluates every step of the process. They conduct thorough safety studies, including Hazard and Operability Studies (HAZOP), risk analyses, and provide recommendations to process scientists during development and tech-transfer. The insights and recommendations from process safety studies often result in minor or major reengineering of the manufacturing equipment design, installation, and operation, ensuring a heightened level of safety in our operations. Our process safety team operates from a fully equipped laboratory featuring advanced tools such as RC1e (MT & HEL), Accelerated Reaction Calorimetry (ARC), DSC, TGA, FBRM, PVM-Online Microscope (MT), equipment for testing powder safety, and VisiMix software. This comprehensive setup allows for a rigorous and proactive approach to process safety, reinforcing our commitment to ensuring the well-being of our operations and personnel.

Over the past 5+ years, Laurus Labs has systematically expanded its flow chemistry capabilities, enhancing our ability to handle reactions and conventional batch processes that may be less favorable from a safety standpoint. Our strong commitment is directed towards reducing our carbon footprint, achieved through significant reductions in solvent consumption and the judicious use of certain precious metal catalysts. Concurrently, we continuously reinforce our analytical capabilities, with a specific focus on tools like ReactIR tailored for flow chemistry applications. Chemistries and chemical processes routinely evaluated for continuous-flow applications encompass Gas-Liquid, Liquid-Liquid (homogeneous & heterogeneous), catalytic reactions involving solid catalysts, and reactions involving metal particles such as Grignard. This also extends to processes like hydrogenation using hydrogen gas, which involves the use of catalysts and metal powders with particle sizes below 200 micrometers, ensuring no agglomeration. Our process engineering labs house various types of flow reactors, including:

Micro Channels:  Corning G1, offering seamless scale-up to G4 at our manufacturing facility Chemtrix
Modular Flow: HANU Creaflow
Plug Flow Reactors:
1. Amar EQ Pinched Tube
2. Technoforce PE 200
3. Technoforce PE 800

These plug-flow reactors seamlessly scale up to the Plug Flow Reactors installed in our manufacturing facility.

For High Solids: Agitated Cell Reactor Continuous Stir Tank Reactor
This comprehensive array of flow reactors allows us to tailor our approach to different types of reactions, facilitating efficient and sustainable processes in line with our commitment to environmental responsibility.

In our commitment to making asymmetric synthesis more environmentally friendly, we have delved into enzyme-catalyzed reactions. Our bio-catalysis capability spans from screening a library of enzymes for a specific transformation, identifying the most suitable enzyme, to optimizing the bio-catalytic process for optimal quality and yield. During the tech-transfer phase, Laurus's engineering team collaborates closely with process scientists and manufacturing personnel to design agitators that achieve the desired agitation profile, spargers for optimal air/oxygen distribution (in gas-liquid flow reactions), and ports for the online monitoring of parameters such as BOD, pH, and feed concentration. Through our subsidiary, Laurus Bio, we have the capacity to backward-integrate bio-catalysis capability for the development and manufacturing of enzymes. This integrated approach allows us to harness the potential of bio-catalysis in a sustainable and efficient manner, contributing to greener and more eco-friendly synthesis processes.