GLP & GDP Compliant Research & Analytical Infrastructure

Scientific Innovation & Advanced Process Chemistry

With 18,000 sq. ft. of research space, 9 specialized laboratories, and 20+ Ph.D. scientists, Chieron drives cutting-edge synthetic chemistry, biocatalysis, and non-infringing process design.

9 Labs
5 Synthesis + 4 Analytical
20+ Ph.D.
Organic Chemistry Scientists
18,000 Sq. Ft.
Modern R&D Built-up Area
Process Development Scope

10 Core R&D Activities

Delivering robust, scalable, and non-infringing chemical routes from mg-scale scouting to validation tonnages.

1

Develop robust and scalable processes for APIs, Intermediates & Specialty products with the highest grade of quality.

2

Developing non-infringing processes & identifying/exploring patent-fencing opportunities to create IP assets.

3

All analytical activities strictly aligned with international regulatory guidelines or customer requirements.

4

Technology transfer of new processes to Validation scale with complete batch records.

5

Technical Package of new processes and technology containing detailed reaction kinetics & thermal data.

6

Technical reply to regulatory queries from EDQM, US-DMF, and international health agencies.

7

Technical Support to business development and global customers.

8

Complete support for filing DMF (US-DMF, CEP, Canada, Australia) and regulatory dossiers.

9

Identification and isolation of Genotoxic / non-genotoxic impurities in process & method development (TTC approach).

10

Detailed impurity profiling during development and in-house synthesis of all reference impurities and their characterization.

Analytical Excellence

ADL – Analytical Development Laboratory

Conforming to ICH, USP, EP, FDA, WHO, and In-house SOP Guidelines.

1

Analytical Method Validation

Method development and validation for KSMs, in-process, intermediate, API, and cleaning verification samples.

2

Genotoxic & Nitrosamines

Carry-over studies of potential mutagenic impurities, nitrosamine trace analysis (LC-MS/MS), and risk assessments.

3

Impurity Fate Mapping & TPF

Theoretical Purge Factor (TPF) determination and spike-recovery studies across synthetic steps.

4

Compendial Equivalence

Verification of pharmacopoeial analytical methods (USP, EP, IP, JP) & method equivalence studies.

5

Stress & Forced Degradation

Forced degradation studies under thermal, photolytic, humidity, acidic, basic, and oxidation conditions.

6

Indicative Stability Studies

Real-time, accelerated, and photo-stability studies under diverse climatic conditions and packaging types.

7

Reference Standard Management

Primary and working standard qualification using HPLC/GC/TGA and NMR/IR/MS structure verification.

8

Impurity Isolation & Synthesis

Preparative HPLC isolation of unknown degradation products followed by spectroscopic structural characterization.

IP Strategy & Protection

Intellectual Property Management (IPM)

Ensuring complete freedom to operate (FTO) and patent fencing for all synthesized molecules.

Core Roles

Innovation support, Infringement Screening, IP-Validation, Freedom-to-Operate (FTO) Analysis, Patent Drafting, Filing, and IP Alerts.

Databases & Tools

CAS SciFinder, USPTO, European Patent Office (EPO), WIPO, Scopus, PubMed, and global patent registries.

Talent Pool

Registered Indian Patent Agents with Organic Chemistry Postgraduates & Ph.Ds with 15+ years of techno-legal patent experience.

Data Security

ISO 9001 Quality Assurance, strict Non-Disclosure Agreements (NDAs), and Enterprise Data Security Software.

Eco-Friendly Innovation

Green Chemistry Principles & Case Studies

Minimizing consumption of organic solvents, promoting water-based reactions, and employing biocatalysis for high atom economy.

Principle #1

Prevention of Toxic Chemicals

Toxic chemicals replaced with enzymatic biocatalysis

Case Study: Sitagliptin Phosphate (Biocatalysis Process)

Eliminated hazardous heavy metal catalysts and reduced toxic solvent waste by 65%.

Principle #2

Ensuring Atom Economy

Maximizing incorporation of reactant atoms into final molecule

Case Study: Lacosamide & Olmesartan Medoxomil

High atom efficiency, yielding minimal by-products and significantly lower E-factor.

Principle #3

Less Hazardous Chemical Syntheses

Designed synthesis - Replacement of pyrophoric chemicals with simple safe RMs

Case Study: Loxoprofen Acid / Sodium

Eliminated pyrophoric reagents in scale-up, vastly enhancing operator safety and process consistency.

Principle #4

Designing Safer Chemicals & Solvents

Promoted water-based and green EHS-convenient reactions

Case Study: Multiple API Syntheses

Drastically reduced VOC emissions and hazardous organic solvent consumption.

Principle #5

Energy Efficiency, Waste Reduction & Catalysis

Lowering activation energy via homogeneous/heterogeneous catalysis

Case Study: Olmesartan Medoxomil, Loxoprofen Na Hydrate

Optimized reaction kinetics, lowering thermal energy needs by 28%.

Principle #6

Telescopic & One-Pot Approach

Sequential reactions in a single vessel without isolating intermediate streams

Case Study: Lacosamide, Olmesartan, Vildagliptin, Loxoprofen

Reduced solvent wash cycles, lowered cycle times, and maximized batch output.