Facilities

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.

Type of facility

Name of grantee

Services Provided/ To be initiated

Environmental and Health Risk Management Plan (EHRMP)

Facilities supporting biotherapeutics development

cGMP Biologics Pilot facility catering to Clinical Grade Drug Substance and Drug Product

 

Shilpa Medicare Pvt. Ltd.

cGMP batch manufacturing of biological products.

Click Here
Centre for Advanced Protein Studies (CAPS) Syngene International Ltd. Analytical characterization services (table with costings). Click Here Click Here
GLP compliant analytical facility for biotherapeutics

Entrepreneurship Development Center

View Website:-

https://bioanalysis.in/

View Brochure:-

https://online.fliphtml5.com/laonc/jyhf/#p=1

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

Process development lab and GMP manufacturing for biotherapeutic

M J Biopharm Ltd, Pune

View Brochure

Development and scale-up of purification process. cGMP manufacturing of clinical trial batches on microbial platform

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Gennova Biopharmaceuticals Ltd, Pune & Sanand

View Website:- https://www.gennova.bio/pdl

View Brochure

Development and scale-up of purification process. cGMP manufacturing of clinical trial batches on mammalian platform

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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
 

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

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.

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Facilities supporting medical device development
Medical Device Prototyping

 

IIT-Kanpur – Mech. Engineering Dept.

Rapid prototyping of medical devices using metals and electronics.

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Yenepoya, Mangalore.

Rapid prototyping of medical devices using biomaterial and tissue engineering.

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C-CAMP, Bangalore

Rapid prototyping microfluidics based medical devices

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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

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

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Huwel Lifesciences Pvt Ltd

Molecular diagnosis of COVID 19 multiplex assay along with screening for other related respiratory diseases

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