Method Development & Validation

Building Materials Science Division (BMSD) - Laboratory Testing, Algorithms & Quality Assurance

BMSD operates a dedicated Building Materials Science Laboratory, structured and managed in alignment with the international standard ISO/IEC 17025:2017, which governs the competence of testing and calibration laboratories. The laboratory supports BITRI's research and innovation efforts by providing high-quality, reliable, and standards-compliant testing services to both internal projects and external stakeholders in the construction and materials sectors. Driving innovation in construction with locally sourced materials, circular‑economy processes and accredited testing for reliable performance.

Analytical Development

Jubilant Biosys has a highly experienced team of analytical specialists to ensure all analytical needs are met as part of its broader CDMO specialities. This includes methods to support raw material release, in process/intermediate testing and final product analysis. - All methods are developed with cGMP quality and are suitable for validation at the appropriate phase. - We follow relevant ICH guidelines such as ICH Q2 (R1) or Pharmacopoeial methods/compendia guidance in combination with client-specific protocols. - Analytical method validation (a protocol-guided activity) ensures that a test procedure is accurate, reproducible, and sensitive within a specified range based on the application of the method. - Through close evaluation of performance characteristics against pre-approved acceptance criteria, analytical method validation assesses an analytical method to demonstrate its suitability for the intended purpose.

Process Research & Development-Analytical Capabilities

Method development. Nitrosamines method development & validation. Documentation as per GLP/FDA requirements for Technology transfer. Polymorph characterization. Forced degradation studies & development. Stability studies as per ICH. Centre of Excellence (CoE-Solid State Chemistry). Genotox potential evaluation.

Bioanalysis

At Jubilant Biosys, our bioanalytical group excels in quantitative LC-MS/MS method development, validation, and study sample analysis. The team has extensive expertise in developing sensitive methods for LC-MS/MS, including analysis of multi-analytes, metabolites, pro-drugs, and photo/temperature sensitive, ex-vivo instable compounds and biomarkers We perform GLP-compliant bioanalysis for regulatory studies and routinely validate methods for new chemical entities in various species. Using advanced technology, our experienced team delivers high-quality data promptly to support drug discovery and development. Our GLP bioanalysis includes method development and validation, sample analysis, and detailed reporting, all adhering to the highest quality standards. By offering both non-GLP and GLP bioanalysis, Jubilant Biosys provides a seamless transition from early-stage research to regulatory approval, supporting our clients in achieving successful drug development outcomes with robust and reliable data.

Analytical Method Development/Validation for CMC

HPLC-UV/PDA/ELSD/Chiral methods for in-process materials, intermediates, NCE APIs, and oligonucleotide synthesis. Elemental Impurities/ (ICP-OES/MS) – as per ICH Q3D. ICH compliant stability studies – as per ICH Q1A. GMP Impurities/Assay by HPLC/UPLC – as per ICH Q3. Forced degradation study. Residual solvents analysis by GC as per ICH guidelines.