BIRAC-Call For Proposal

Special Call for Proposals on Biosimilars - 17th Batch

Introduction

Biotechnology Industry Partnership Programme (BIPP), an Advanced Technology scheme approved by the Government is a unique initiative of the Department of Biotechnology (DBT) to nurture R&D and innovation in Biotech Industry. DBT invites proposals from Indian Companies working on Biosimilars under BIPP. Proposals are invited in the field of Biosimilars with emphasis on overcoming cloning, fermentation and purification complexities to maximize yield and commercial viability. Proposals may include one or more of the following, but not limited to:

• Product Development

ü Establishment and Maintenance of Master and Working cell banks.

ü Cell Culture Media Optimization

ü Protein Expression

ü Final and In process product characterization techniques : e.g. charged species , isoforms, glycoforms, product

ü Formulation

ü Protein Purification

ü Bioanalytical assay development including in-vitro and in-vivo bioassays, immunogenicity assays etc

ü Virus filtration and clearance methodologies and challenge tests - method establishment and validation

ü 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

• Scale up

• Product or Process Validation

• Comparability Studies

• Stability Studies

• Pre-Clinical and Clinical Evaluation for Efficacy and Safety

• Any other innovation involved during development of Biosimilar (s)

KEY FEATURES OF THE CALL

Supports
- Large, medium, small scale industry, start ups on cost sharing basis
- High risk, discoverylinked 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.

WHO CAN APPLY?

A single or consortia of Indian company (ies) - Small, Medium or Large having DSIR* recognized in-house R&D unit(s). An Indian Company is defined as one which is registered under “The Indian Companies Act, 1956” and in which 51% (or more) of the ownership is held by Indian citizens (including NRIs).
The proposals can be submitted:
•        by an Indian Company alone; or
•        by an Indian Company along public sector R&D institution(s), organization(s), laboratory (ies), university (ies) etc.; or
•        by a consortium of Indian Companies; or
•        by a consortium of Indian Companies along with public sector R&D institution(s), organization(s), laboratory (ies), university (ies) etc.

(*Companies 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)

HOW TO APPLY?

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

Log on the BIRAP website (www.birapdbt.nic.in)
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.
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.
Once you login, you would be navigated to the page displaying BIPP link.
Click on the BIPP link under Programmes and the active call would be highlighted.
Click on the new call and proceed towards proposal submission.

Further details on How to submit a proposal would be available in the BIPP User Guide available on the website.
The proposals should be submitted on or before 31st October, 2011 (midnight).

Company User Registration is open round the clock.

Online Proposal Submission would begin from 01st October, 2011. No Hard Copy to be submitted, Proposals submitted online only would be considered.

Last date for Submission of Proposals: 31st October, 2011
For further details, please contact:

Dr. Renu Swarup,
Advisor Incharge-BIPP, Department of Biotechnology,
Block No: 2, 7th Floor, CGO Complex, Lodi Road, New Delhi – 110 003, India;
E-mail: swarup@dbt.nic.in

**For any queries related to Online submission of proposals, please write to bipp.dbt@nic.in

Detailed guidelines for the scheme including eligible project categories to be supported are available at
http://dbtindia.nic.in/uniquepage.asp?id_pk=680 ; http://www.birapdbt.nic.in/programmes.php

ANNOUNCEMENT DATE | LAST SUBMISSION DATE

Announcement Date: 01-10-2011
Last Submission Date: 31-10-2011 12:00 AM

Special Call for Proposals on Biosimilars - 17th Batch

Introduction

KEY FEATURES OF THE CALL

WHO CAN APPLY?

HOW TO APPLY?

ANNOUNCEMENT DATE | LAST SUBMISSION DATE

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