ACRNS analytical technologies headed by Dr. Dipak Thakur who has a global experience in the field of analytical and protein characterization. He is ably supported by talented team of expert scientists with industry experience.
Dr. Dipak Thakur obtained M.Sc. in Chemistry from Mumbai University and PhD in analytical chemistry from Barnett Institute of Chemical and Biological analysis at Northeastern University, Boston, MA, under the guidance of Prof. Barry L. Karger. During his doctoral studies he has worked on development of sensitive, high performance analytical methods for comprehensive characterization of proteins and glycoproteins from the samples of clinical and biopharmaceutical importance. Following completion of his doctoral studies, he had worked as a scientist/analytical lead in technical development group at Novartis vaccines and diagnostics. In 2013, he returned to India and joined Wockhardt R&D group to setup high end protein characterization and comparability laboratory which supports the development of processes and formulations of biopharmaceuticals. Since June 2018, he has founded ACRNS which provides consultancy and distributorship to help bring analytical technologies to analytical and product developers. Specifically, ACRNS consultancy and distributorship will contribute in following areas:
- Setting up of facility: The company will provide consultancy services to train people in analytical instrument operation, experiment planning and data interpretation. Design of experiments to demonstrate biosimilarity involves QTTP (Quality target product profile) identification through comprehensive characterization of innovator product, development of orthogonal methods for each quality attribute, implementation of state-of-the-art technologies to characterize protein, method development, qualification, data interpretation and statistical evaluation.
- Support to investigational studies to address regulatory queries, batch failures, process and product developments. During investigational studies, a good understanding of the products & processes and suitable methods are required to draw a conclusion for addressing questions posed during the investigation. We provide analytical expertise to design
experiments and to draw conclusion based on interpretation of the data. We offer our expertise based on sample preparation strategies, use of appropriate analytical techniques and generation and evaluation of analytical data. Workflows and services:
- Exploration of suitable analytical strategy customised for molecule type and nature of sample.
- Establishing a multiple attribute method for evaluation of change in process.
- Introduction of customised workflows for testing of in-process samples using hyphenated techniques such as CE-MS, 2-D LC-MS.
- Introduction of mass-spectrometry based methods in quality control laboratories for routine in-process testing, investigative studies and process optimization, scale-up studies.
- Implementing advanced applications of mass spectrometry for higher order structure comparison between innovator and biosimilar as well as between biosimilars before and after process change.
- 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.
- Support to physicochemical 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.
- Support to data processing and interpretation.