Research Facility : VACCINE DESIGN AND DEVELOPMENT CENTRE
The goal and vision of the VDDC are to build and develop capacity in utilizing a comprehensive end to- end platform for accelerating vaccine discovery and development and bridging the gap between academic and industry to stimulate and strengthen vaccine R & D. VDDC offers pre GMP-like facilities for production of subunit protein-based vaccines and biotherapeutics upto drug substance and comprehensive analytical characterization.
The facility made up of in ~6000 sq ft, is equipped with ready to use state of the art infrastructure to rapidly expand mid-level production of promising vaccine candidates (drug substance). The lab is designed with GLP grade production facility which comprises GMP-like ISO 7 (Class 10,000) clean rooms with following main components to facilitate the process development.
- Culture room
- Up-stream processing (UPS),
- Down-stream processing (DSP)
- Analytical lab
Our major strengths in vaccine drug substance and biotherapeutics production include the following:
- Designing of protein-based vaccine candidates
We design vaccine candidates by using structure vaccinology, deep bioinformatics and A1-based tools and supported by preliminary in vitro and in vivo study.
- Production and characterization of soluble recombinant protein and GMP-compliant cell banks
The clean room facility is equipped with single-use cell bioreactors for production of soluble proteins or biotherapeutics in both bacterial and mammalian cell cultures by using different conditions to maximize the soluble protein expression. Master Cell Banks (MCB), Working Cell Banks (WCB) are produced within the facility and subjected to extensive characterization.
- Pre-clinical and clinical batches drug substance production
Our clean room facility supports vaccine (drug substance) production upto process scale up to 10L scale size in single-use stirred bioreactor. To assure product quality and flexibility, the entire process is dependent on a totally disposable pipeline built on single-use materials and equipment. An excellent combination of filtering and chromatography processes ensures the efficient removal of impurities.
- Comprehensive biochemical, biophysical characterization and Quality control
We employ various in vitro assays (SDS-PAGE, Western blot, ELISA, CD spectroscopy, SEC-HPLC Analysis, DLS, SEM, TEM, Zeta potential analyser, binding assays etc) for in-depth antigen (drug substance) analysis. Through a wide range of interconnected strategies, including the use of cutting-edge laboratory equipment, and the choice of raw materials for each pilot batch and pre-GMP production run, we preserve strict product quality standards.
Name of faculty members and Scientists
The centre/facility is open to providing services to academia and industry. For any queries, contact the following
Dr. Amit Awasthi