Expertise @ GeneSys Biotechnology Centre
GeneSys is fully integrated and equipped to perform end-to-end development of biosimilars, including clonal design/cell-line development, recombinant process development, extensive analytical development (in-vitro, in-vivo, characterization techniques, etc.), toxicology & clinical development, and GMP commercial manufacturing of Drug Substance.
Research & Development
R&D is the core strength of GeneSys. The team of researchers and scientists come from multi-disciplinary background, from national & international universities and reputed biotech companies.
A state-of-the-art R&D lab is located at Genome Valley, Hyderabad, which has well equipped molecular biology, Upstream process development, Downstream process development, Formulation development, analytical development, characterization, Bioassay development (cell culture) laboratories.
Our approach for biosimilar development includes systematic development beginning with predefined objectives, emphasizing product and process understanding based on sound science and quality risk assessment. Development would entail QbD principles, design of experiments, Characterization of physico-chemical properties and biological activity by comparability to the innovator product. Post demonstration of high similarity, Safety & Efficacy shall be demonstrated by pre-clinical & clinical studies.
Development team comprises of process and analytical scientists specializing in microbial fermentation processes and methods. Scientifically and technically sound techniques are used for bioprocess optimization in order to generate consistent, highly similar quality and cost effective (optimal titer) insulin biosimilars.
A rigorous science and development steps are taken into consideration to demonstrate that GeneSys products meet the global biosimilarity requirements for all critical quality attributes when compared to reference products.
Driven by process innovation, GeneSys has established proprietary bacterial expression technology that enables speed, success and capable of high yielding product. Thorough understanding of microbial fermentation process sciences together with differentiated and extensive bioanalytical characterization capabilities allows us to accelerate development of right biosimilar.
GMP Manufacturing Facility (Drug Substance)
GeneSys has recently opened its state-of-the-art GMP drug substance manufacturing facility for its biosimilars. Our team has rich experience in manufacturing sciences and is focussed on consistently delivering high-quality biosimilar medicines using robust processes and appropriate control strategy. We have a versatile experience in the complex manufacturing of biologic medicines (recombinant technology) covering both the upstream and downstream to deliver a consistent, high-quality drug substance (active ingredient) at commercial scale.
A quality-oriented approach is in place to adhere to global quality standards. A bioprocess platform technology has been established, which ensures the quality characteristics of the products are maintained during the batch manufacturing.
GeneSys is committed to conduct development and manufacturing of its products with a “patient first” approach and employs Quality Management Systems to ensure adherence to high quality.
GLP based pre-clinical studies have been completed for four of our molecules. Clinical studies for our biosimilar candidates are going to be initiated shortly.
GeneSys has an experienced clinical development team to handle end-to-end execution of clinical requirements, including design and execution of various phases of clinical trials, post-marketing surveillance, pharmaco-vigilance, medical writing, data management, biostatistics and quality assurance.