The ADEEP Technology Center (Central R&D Hub) in Hyderabad drives high-potency process development, green biocatalysis, ICH-grade analytical validation, and non-infringing intellectual property for regulated pharmaceutical markets worldwide.
Equipped with cutting-edge synthesis hoods, pressure autoclaves, cryo-reactors, and high-end chromatography suites to handle the most challenging chemical transformations.
24 walk-in high-velocity fume hoods with continuous nitrogen manifolds, inert gas purge, and automated temperature controllers for complex multi-step convergent synthesis.
Specialized hydrogenation autoclave suite capable of operating up to 50 bar pressure for catalytic reduction, debenzylation, and asymmetric stereoselective hydrogenations.
Dedicated enzyme screening and biocatalytic process development laboratory for transaminases, ketoreductases, and esterases, delivering >99.8% enantiomeric excess under aqueous conditions.
Designing cost-effective, non-infringing, robust, and environmentally benign chemical routes that scale seamlessly from grams to commercial metric tons.
Systematic implementation of ICH Q8(R2) Quality by Design guidelines. Defining Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) to establish reliable design spaces.
Independent patent landscape analysis to scout non-infringing synthetic pathways, bypassing innovator claims and granting our partners early-to-market generic launch advantages.
Minimizing the process E-Factor by substituting hazardous solvents with greener alternatives, recycling process streams, and optimizing stoichiometric atom efficiency.
State-of-the-art analytical instrumentation verifying molecular identity, assay purity, chiral enantiopurity, residual solvents, and polymorphic stability.
Validated HPLC, UPLC, and Gas Chromatography methods with PDA, UV, RI, and FID detectors developed under strict ICH Q2(R1) validation protocols.
Stress testing under acid, base, oxidation, thermal, and photolytic ICH Q1A conditions to demonstrate method specificity and stability-indicating capabilities.
Walk-in and reach-in stability chambers continuously monitored with 21 CFR Part 11 compliant data loggers covering long-term, intermediate, and accelerated conditions.
Auditor-grade characterization of process-related impurities, degradation products, genotoxic impurities (GTIs), and nitrosamines meeting ICH and EMA thresholds.
Preparative HPLC isolation of unknown impurities above 0.05% threshold, followed by multi-nuclear NMR, LC-MS/MS, and high-resolution MS characterization.
Comprehensive risk assessments conducted across all synthesis routes, raw materials, solvents, and recovered reagents to prevent NDMA, NDEA, and complex NDSRIs.
Risk-based elemental impurity evaluation covering Class 1, 2A, 2B, and 3 elements via ICP-MS, ensuring compliance with global pharmacopoeial monographs.
Proven tech-transfer protocols transitioning processes from micro-bench testing to 500L pilot reactors and multi-ton commercial manufacturing trains.
Gram-scale feasibility, reaction screening, safety calorimetry (DSC), and initial impurity identification.
Demonstrating process reproducibility, solvent recovery parameters, and preliminary ICH stability testing.
Equipment engineering, filtration kinetics, drying curves, and Technology Transfer Dossier (TTD) generation.
Process Performance Qualification (PPQ) batches, batch manufacturing records (BMR), and commercial release.
Our dedicated intellectual property cell actively patents novel, non-infringing synthetic processes and provides robust Freedom-to-Operate guarantees to our global customers.
From route scouting to commercial validation, ADEEP’s research team accelerates your time-to-market under strict confidentiality and international regulatory compliance.
