The Biotechnology Industry Partnership Programme (BIPP), under the Department of Biotechnology (DBT), has invited proposals in the field of biosimilars with emphasis on overcoming cloning, fermentation and purification complexities to maximize yield and commercial viability.
BIPP, a unique initiative of the government to nurture Research and Development (R&D) and innovation in biotech industry, is also an advanced technology scheme approved by the government.
Under this programme, the stress will be on product development which include establishment and maintenance of master and working cell banks; cell culture media optimization; protein expression; final and in process product characterization techniques: e.g. charged species , isoforms, glycoforms, product; formulation; protein purification; bioanalytical assay development including in-vitro and in-vivo bioassays, immunogenicity assays etc; virus filtration and clearance methodologies and challenge tests - method establishment and validation; and delivery device development that are intimately associated with biologics e.g. prefilled syringes, disposable cartridges, pens, inhalers, etc.
Besides, the focus of the programme will be on evaluation in suitable cell-culture and animal model systems; scale up; product or process validation; comparability studies; stability studies; pre-clinical and clinical evaluation for efficacy and safety; and any other innovation involved during development of biosimilar(s).
A single or consortia of Indian companies--- small, medium or large---- having DSIR recognized in-house R&D units, an Indian company alone or by an Indian company along public sector R&D institutions, organizations, laboratories, universities, etc or by a consortium of Indian companies or by a consortium of Indian companies along with public sector R&D institutions, organizations, laboratories, universities, etc are eligible to participate in the programme.