Experience our world-class infrastructure
Our R&D Center
Aryastha Life Sciences is a beacon of end-to-end solutions, global proficiency, and strategic collaboration in the Contract Research Development and Manufacturing Organization (CRDMO) landscape. We offer holistic solutions, international expertise, and strategic synergy. With trust, communication, and collaboration as pillars and steer the journey from concept to market. Our integrated approach ensures an efficient drug development voyage. Our services span Discovery and Preclinical Development, Formulation Advancement, Analytical Evaluation, Clinical Trial material, Commercialization and Manufacturing, and Regulatory Assistance.
Drug Discovery and Development Services
Discovery Chemistry Lab
Aryastha’s Discovery Chemistry Lab excels in hit identification, lead optimization, and preclinical candidate selection. We combine computational modeling, AI-driven design, and cryo-EM and X-ray crystallography structural insights to guide hit-to-lead progression. Leveraging organ-on-a-chip models, microfluidic platforms, and advanced imaging techniques, we enhance ADME/T profiling and safety assessment.
Analytical Chemistry Lab
Drug Substance Characterization, Control, and Compliance
Analytical Method Development & Validation
- Tailored methods for drug substance characterization
- Compliance with ICH Q2(R2) and regulatory standards
Structural Elucidation & Characterization
- Spectroscopic techniques (NMR, FTIR, MS, XRPD)
- Solid-state characterization for polymorphs and salts
Impurity Profiling & Control
- Identification and quantification of process-related and degradation impurities
- Support for ICH Q3A/Q3B impurity guidelines
Stability Studies (Drug Substance)
- Forced degradation and stability-indicating method development
- ICH-guided accelerated and long-term stability studies
Chiral & Enantiomeric Purity Testing
- Advanced HPLC/UPLC and chiral separation platforms
Residual Solvent & Elemental Impurity Analysis
- GC/HS-GC for solvents (ICH Q3C)
- ICP-MS for elemental impurities (ICH Q3D)
Reference Standards Qualification
- Characterization and qualification of in-house and pharmacopeial standards
Infrastructure
Our analytical laboratories are equipped with advanced platforms for Drug
- HPLC, UPLC, LC-MS/MS, GC-MS
- NMR, XRPD, DSC, TGA for solid-state characterization
- ICP-MS, FTIR, UV/Vis
- GMP stability chambers (ICH zones I–IV)
- Fully compliant with 21 CFR Part 11 and global data integrity standards
Our specialized lab offers a comprehensive suite of services
DMPK Lab
Aryastha’s Drug Metabolism and Pharmacokinetics (DMPK) Lab is harnessing the potential of pharmaceutical compounds. Our specialized lab offers a comprehensive suite of services spanning in vitro ADMET, in vivo pharmacokinetics, regulatory DMPK, and beyond. With a focus on accuracy and reliability, rapid evaluation of drug properties and toxicity is essential for successful preclinical and clinical development
Biology Lab
Our biology platform integrates seamlessly with your research goals, covering assay development, target validation, in vitro and in vivo pharmacology, biomarker discovery, and more. Whether you’re exploring oncology, neuroscience, or infectious diseases, our approach combines scientific rigor with creativity to de-risk your programs and accelerate the journey to clinical candidates.
Aryastha Life Sciences is a beacon of end-to-end solutions, global proficiency, and strategic collaboration in the Contract Development and Manufacturing Organization (CDMO) landscape. We offer holistic solutions, international expertise, and strategic synergy. With trust, communication, and collaboration as pillars and steer the journey from concept to market. Our integrated approach ensures an efficient drug development voyage. Our services span Discovery and Preclinical Development, Formulation Advancement, Analytical Evaluation, Clinical Trial material, Commercialization and Manufacturing, and Regulatory Assistance.
CDMO Lab
Process Development Lab, Kilo Lab, Small Pilot Plant & Manufacturing Plant
- Process Development Lab
- Exploration of novel routes and suitable starting materials
- Route scouting experiments to identify the most efficient, safe, and scalable approach
- Process development from milligrams to kilograms, and robust large-scale production
- Identification and isolation of potential impurities to maintain product purity
- Production of drug candidates for non-GLP and GLP toxicology studies
- Seamless technology transfer to GMP facilities
- Quality by Design (QbD) principles, integrating analytical and risk-management methodologies throughout the manufacturing stages
Route Scouting
- Identifying a safe, efficient, and cost-effective process for large-scale production
- Key questions encompass safety considerations, raw material availability and affordability, patent implications, intermediate stability, purification methods, environmental concerns, and alternative routes
- Regulatory compliance is also weighed, shaping decisions that optimize time, cost, and quality.
- Our approach integrates these crucial aspects to formulate an optimized route.
Route exploration and process development
- Designing the Route
- Retro-synthetic Analysis
- Evaluation for Yield Enhancement
- Safety Management through Thermodynamic Studies
Aryastha Life Sciences stands as a trusted global partner in the Contract Development and Manufacturing Organization (CDMO) landscape. We provide end-to-end, solutions that take your innovation from concept to commercialization with speed, compliance, and quality.
Drug Substance Development
- Process chemistry and scale-up for NCEs, generics, and potent drug substance
- Comprehensive analytical method development, validation, and impurity profiling
- ICH-aligned stability and solid-state characterization (salts, polymorphs, hydrates)
Formulation & Drug Product Development
- Novel dosage forms, complex generics, biologics, and advanced delivery systems
- Pre-formulation through to clinical-ready drug product manufacturing
Analytical Sciences & Quality Control
- End-to-end analytical support for drug substance and drug product
- GMP release testing, stability studies, bioanalytical support
- Regulatory, CMC documentation for IND, NDA, ANDA, and global filings
Clinical Trial Supply
- GMP manufacturing of clinical trial materials (Phases I–III)
- Packaging, labeling, and logistics to global sites with full compliance
Commercial Manufacturing
- Scalable DS and drug product manufacturing under GMP standards
- Flexible production platforms to support launch, lifecycle management, and market expansion
Regulatory & Strategic Support
- CMC strategy, gap analysis, and dossier preparation Support across FDA, EMA, MHRA, PMDA, DCGI and other global agencies
Drug Substance Manufacturing Infrastructure
Pilot-Scale Facilities
- Multi-purpose pilot plant designed for early development and scale-up
- Reactor capacity: 5 L – 50 L (glass-lined and stainless-steel reactors)
- Operating temperature range: -78°C to +250°C
- Pressure capability: Up to 10 bar (suitable for hydrogenation, high-pressure chemistry)
- Dedicated fume hoods, cryogenic systems, and inert atmosphere setups (N₂/Ar)
- Salt screening, polymorph studies, crystallization development
- Analytical support for in-process monitoring and method development
- Safety systems for handling hazardous and high-energy chemistries
GMP Manufacturing Facilities
- 1. Reactor suites with cGMP-compliant stainless steel and glass-lined reactors
- 18 Reactors (12 SSR and 6 GL)
- Total reaction capacity of 60 KL
- Reactor capacities of 250 L to 5 KL
- 2. Suitable for both commercial as well as pilot scale activities
- 3. Multi-step synthesis and scale-up to kilogram scale
- 4. Controlled environments (HVAC, AHUs) to meet regulatory GMP standards
- 5. Separate areas for potent compound handling (oncology APIs, HPAPIs)
- 6. Crystallizers and filtration/drying equipment for isolation and purification
- 7. Cleanroom-compliant material and personnel flows to prevent cross-contamination
- 8. Stability chambers (ICH-compliant) for DS shelf-life and forced degradation studies
- 9. QA/QC labs with HPLC, LC-MS/MS, NMR, XRPD, DSC, TGA, ICP-MS for release and regulatory testing
- 10. Documentation aligned with FDA, EMA, and ICH guidelines (21 CFR Part 11 data integrity compliance)
