ACRNS Analytical Technologies Pvt Ltd

www.acrnstech.com

ACRNS analytical technologies provides services in the area of analytical consultation, laboratory setup, training of analysts in instrumentation and data interpretation to address requirement of skills, expertise, trouble shooting and development of workflows for regulatory submission. Workflows and services: 1. Exploration of suitable analytical strategy customized for molecule type and nature of sample. 2. Establishing a multiple attribute method for evaluation of change in process. 3. Introduction of customized workflows for testing of in-process samples using hyphenated techniques such as CE-MS, 2-D LC-MS. 4. Introduction of mass-spectrometry based methods in quality control laboratories for routine in-process testing, investigative studies and process optimization, scale-up studies. 5. Implementing advanced applications of mass spectrometry for higher order structure comparison between innovator and bio-similar as well as between biosimilars before and after process change. 6. Support to regulatory submissions and handling of queries from regulators in case of high-end characterization involving rare expertise or difficult to investigate a structural modification. 7. Support to physico-chemical characterization for biosimilarity demonstration through use of techniques such as LC-MS/MS, ICP-MS, FTIR, CD, DSC, Fluorescence, AUC, DLS and other biophysical tools. 8. Support to data processing and interpretation. ACRNS analytical technology is also an official distributor of Protein metrics software (PMI) which is a state-of-art tool for interpretation of mass spectrometry data for proteins and peptides.

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ACRNS analytical technologies provides services in the area of analytical consultation, laboratory setup, training of analysts in instrumentation and data interpretation to address requirement of skills, expertise, trouble shooting and development of workflows for regulatory submission. Workflows and services: 1. Exploration of suitable analytical strategy customized for molecule type and nature of sample. 2. Establishing a multiple attribute method for evaluation of change in process. 3. Introduction of customized workflows for testing of in-process samples using hyphenated techniques such as CE-MS, 2-D LC-MS. 4. Introduction of mass-spectrometry based methods in quality control laboratories for routine in-process testing, investigative studies and process optimization, scale-up studies. 5. Implementing advanced applications of mass spectrometry for higher order structure comparison between innovator and bio-similar as well as between biosimilars before and after process change. 6. Support to regulatory submissions and handling of queries from regulators in case of high-end characterization involving rare expertise or difficult to investigate a structural modification. 7. Support to physico-chemical characterization for biosimilarity demonstration through use of techniques such as LC-MS/MS, ICP-MS, FTIR, CD, DSC, Fluorescence, AUC, DLS and other biophysical tools. 8. Support to data processing and interpretation. ACRNS analytical technology is also an official distributor of Protein metrics software (PMI) which is a state-of-art tool for interpretation of mass spectrometry data for proteins and peptides.

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City (Headquarters)

Mumbai

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Employees

1-10

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Founded

2018

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