The National Biopharma Mission supports establishment of GCLP, GLP, GMP and Med Tech facilities.
GCLP: Biopharmaceuticals (mAbs and vaccines) development is a time taking and resource intensive process (8-10 years for a product to reach market and estimated cost of $800 million per NME product) with high rate of failure due to lack of efficacy and safety in later stages of development (FDA data shows 50% failure for Phase III products due to lack of efficacy and 30-40% due to safety). National Biopharma Mission aims to fill the current gap of a centralized GCLP compliant facility which will provide services for clinical immunology testing to support conduct of vaccine clinical trials for regulatory submissions. NBM supports establishment of GCLP facilities for characterization and validation of bio therapeutics (therapeutic proteins and monoclonal antibodies).
GLP: Regulatory approval of complex biological molecules involves extensive and advanced analytics including assessment of physiochemical characteristics, efficacy, immunogenicity (antidrug antibody, ADA), contamination, strength etc. The mission has supported establishment of a state-of -the-art advanced analytical characterization facility at Syngene, Biocon Park, Bengaluru. The skilled and experienced staff of Syngene has started providing affordable analytical services/service packages to star-ups, SMEs, and academia.
GMP: NBM supports establishment of GMP compliant facilities to provide services for development of preclinical and clinical batches of biosimilars and novel MABs; generating relevant data (assay for product characterization and release, assays for in process controls, stability testing) and provide support for regulatory documentation towards fulfilling CMC requirements for IND submission.
MedTech Facilities: NBM supports establishment of facilities for design and development of medical devices to help reduce the time and cost of the developmental cycle. To this end, we envisage supporting facilities in the areas of prototyping and testing for medical devices and diagnostics.
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Type of facility |
Name of grantee |
Services Provided/ To be initiated |
Environmental and Health Risk Management Plan (EHRMP) |
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| Facilities supporting biotherapeutics development | ||||
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cGMP Biologics Pilot facility catering to Clinical Grade Drug Substance and Drug Product
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Shilpa Medicare Pvt. Ltd. |
cGMP batch manufacturing of biological products. |
Click Here | |
| Centre for Advanced Protein Studies (CAPS) |
Rate Card
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Analytical characterization services (table with costings). Click Here | Click Here | |
| GLP compliant analytical facility for biotherapeutics | Physico-chemical, structural and functional characterization of biotherapeutic molecules using state-of-the art analytical techniques. | Click Here | ||
| Indian Institute of Chemical Technology (IICT), Hyderabad | Physico-chemical, structural and functional characterization of biotherapeutic molecules using state-of-the art analytical techniques. | Click Here | ||
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Process development lab and GMP manufacturing for biotherapeutic |
M J Biopharm Ltd, Pune |
Development and scale-up of purification process. cGMP manufacturing of clinical trial batches on microbial platform |
Click Here | |
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Gennova Biopharmaceuticals Ltd, Pune & Sanand |
Development and scale-up of purification process. cGMP manufacturing of clinical trial batches on mammalian platform |
Click Here | ||
| Cell Line Repositories |
Microbial |
CSIR-Institute of Microbia Technology (CSIR-IMTech), Chandigarh | Procurement, Characterization and distribution of microbial strains for commercial manufacturing and laboratory testing. Characterization of cell banks as per ICH guidelines and storage services for cell banks. | Click Here |
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Mammalian |
National center for Cell Science (NCCS), Pune | Procurement, Characterization and distribution of mammalian cell lines for commercial manufacturing and laboratory testing. Characterization of cell banks as per ICH guidelines and storage services for cell banks. | Click Here | |
| Facilities supporting vaccine development | ||||
| Good Clinical Lab. Practices (GCLP) Lab. for Viral Assays |
Interactive Research School for Health Affairs (IRSHA), Pune View Website:- https://irsha.bharatividyapeeth.edu/ |
Dengue NS1, Dengue IgM and Dengue PRNT 50 assay (NABL accredited). Assays for Humoral and Cell Mediated responses and Detection and Quantitation of viruses. |
Click Here | |
| Good Clinical Lab. Practices (GCLP) Lab. for Bacterial Assays |
KIMS, Rajya Vokkaligara Sangha, Bangalore |
Estimation of IgG antibody concentration by ELISA and functional antibody titers (opsonophagocytic antibodies) through Opsonophagocytic antibody (OPA) assays. |
Click Here | |
| Facilities supporting medical device development | ||||
| Medical Device Prototyping
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IIT-Kanpur – Mech. Engineering Dept. |
Rapid prototyping of medical devices using metals and electronics. |
Click Here | |
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Yenepoya, Mangalore. |
Rapid prototyping of medical devices using biomaterial and tissue engineering. |
Click Here | ||
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C-CAMP, Bangalore |
Rapid prototyping microfluidics based medical devices |
Click Here | ||
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Netra Accelerator Foundation, Aurangabad GSM, MIT Academy Research |
Rapid prototyping of medical devices using plastics and electronics | Click Here | ||
| Medical Device Testing |
Palamur Bioscience Pvt. Ltd., Hyderabad. |
Pre-clinical testing of invasive medical devices in swine model. | Click Here | |
| EMI/EMC Testing of Medical Devices |
IIT-Kanpur- Elec. Engineering Dept. |
EMI/EMC and electrical safety testing of electronic medical devices | ||
| SAMEER (Society for Applied Microwave Elec Engg & Research), Mumbai | EMI/EMC and electrical safety testing of electronic medical devices | Click Here | ||
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Medical Device Production Facility |
Andhra Pradesh MedTech Zone |
COVID MedTech Manufacturing & Development Strategy CoMMAND Strategy 1. Point of Care diagnostic kit for Covid-19 based on PCR technology 2. Point of care serological test anti-body based 3. Ventilator |
Click Here | |
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Huwel Lifesciences Pvt Ltd |
Molecular diagnosis of COVID 19 multiplex assay along with screening for other related respiratory diseases |
Click Here Click Here |
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