Call For Proposal

Special Call for Proposals on Biosimilars-8th Batch

Department of Biotechnology (DBT) invites proposals from Indian Companies working on Biosimilars under Biotechnology Industry Partnership Programme (BIPP), a Government partnership with industry for support on a cost sharing basis for development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities. BIPP has been initiated under Biotechnology Industry Research Assistance Programme (BIRAP), a unique initiative of DBT being implemented in partnership with ABLE and BCIL to nurture R&D and innovation in Biotech Industry. Biotech Consortium India Limited (BCIL) is the BIPP Management Agency and will ensure maintenance of strict confidentiality of the proposals as per DBT norms.

For the first time under BIPP, proposals are invited exclusively in the field of Biosimilars, which may include one or more of the following innovative element(s), but not limited to:

  • Product Development
    • Establishment and Maintenance of Master and Working cell banks
    • Cell Culture Media Optimization
    • Protein Expression
    • Final and Inprocess 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
    • Viral clearance methodologies and challenge tests - method establishment and validation
    • Delivery device development that are intimately associated with biologics e.g. prefilled syringes, disposable cartridges, pens, inhalers etc.
  • Evaluation in suitable cell-culture and animal model systems
  • Clinical Trials and safety
  • Scale up
  • Technology Transfers
  • Product or Process Validation
  • Quality unit setup
  • Comparability Studies
  • Stability Studies and,
  • Any other innovation involved during the development of Biosimilar(s)

Supports:

  • Large, medium, small scale companies; start-ups on cost sharing basis
  • High risk, discovery linked innovation
  • Accelerated technology development
  • Evaluation and validation of biotech products
  • Indigenous discovery, innovation and technology to products
  • Products of national relevance or public benefit
Varying models of grants, loans or grant + loan available

A single or consortia of Indian “for profit” biosimilar company (ies) - Small, Medium or Large having DSIR* recognized in-house R&D unit(s).  An Indian Company is defined as one in which more than 51% of the ownership is held by Indian citizens (including NRIs).


The proposals can be submitted:

  • solely by an Indian Company; or
  • jointly by an Indian Company and National R&D Organizations or Institutions; or
  • by a group of Indian Companies along with National Research Organizations etc.

(*The companies who are in the process of obtaining DSIR recognition may also apply along with the proof of application to DSIR. However, the final decision on such applications would be subject to their getting DSIR recognition.)

Proposals are required to be submitted online only. To submit a proposal online, please follow the following steps:

1.      Log on the BIRAP website (www.birapdbt.nic.in)
2.      If you are a registered user, log-on using the credentials, else you need to register your company with by clicking on New User Registration.
3.      In case of new user registration, a computer generated password would be sent to the email-id provided at the time of registration. The password can be changed later.
4.      Once you login, you would be navigated to the page displaying BIPP link.
5.      Click on the BIPP link under Programmes and the active call would be highlighted.
6.      Click on the new call and proceed towards proposal submission.
7.      Further details on How to submit a proposal would be available in the BIPP User Guide available on the website.
8.      The proposals should be submitted on or before 15th September, 2010.
Company User Registration is open round the clock.
Online Proposal Submission would begin from 1st August,2010
No Hard Copy to be submitted, Proposals submitted online only would be considered.

Last date for Submission of Proposals: 15th September,2010

For further details, please contact:
Dr. Renu Swarup, Advisor Incharge-BIPP, Department of Biotechnology, E-mail:  swarup@dbt.nic.in

Detailed guidelines for the scheme
including eligible project categories to be supported are available at
:Dr. Renu Swarup, Advisor Incharge-BIPP, Department of Biotechnology, E-mail: swarup@dbt.nic.in
:Dr. Renu Swarup, Advisor Incharge-BIPP, Department of Biotechnology, E-mail: swarup@dbt.nic.in

Announcement Date: 01-08-2010
Last Submission Date: 16-09-2010 12:00 AM

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