NABI Bio
North American Biomedical Institute
NABI Bio is a leading institute in India specializing in agri-food and biomanufacturing. They offer expertise in biocompatibility testing for various applications.
The National Agri-Food and Biomanufacturing Institute (NABI Bio) is a prominent research institution in India dedicated to advancements in agri-food and biomanufacturing. As a key player in the field, NABI Bio provides specialized services in biocompatibility testing, crucial for ensuring the safety and efficacy of various products and materials. Their commitment to innovation and research makes them a valuable partner for organizations seeking expert testing solutions in the biomanufacturing sector. NABI Bio's focus extends to cutting-edge research and development, fostering a collaborative environment for scientists and researchers. The institute's infrastructure supports a wide range of scientific disciplines, contributing to its robust capabilities in specialized testing services like biocompatibility. Their work is essential for industries that require stringent quality control and regulatory compliance.
About
**Who they are**
NABI Bio is an institute in India specializing in agri-food and biomanufacturing, offering expertise in biocompatibility testing for medical devices.
**Expertise & scope**
* Conducts biocompatibility assessments as part of overall medical device safety evaluations, adhering to ISO 10993 standards.
* Provides comprehensive pre-clinical testing and consulting services for medical devices.
* Offers expertise in Biological Evaluation Plans (BEP) to determine potential risks and establish testing strategies.
* Performs various cytotoxicity tests, including MEM Elution, Direct Contact, Agar Diffusion, MTT Cytotoxicity, XTT Cytotoxicity, and Neutral Red Uptake.
* Specializes in Chemical Characterization and Toxicological evaluation.
**Reputation / proof points**
* Operates modern laboratories.
* Focuses on providing cost-effective solutions.
NABI Bio is an institute in India specializing in agri-food and biomanufacturing, offering expertise in biocompatibility testing for medical devices.
**Expertise & scope**
* Conducts biocompatibility assessments as part of overall medical device safety evaluations, adhering to ISO 10993 standards.
* Provides comprehensive pre-clinical testing and consulting services for medical devices.
* Offers expertise in Biological Evaluation Plans (BEP) to determine potential risks and establish testing strategies.
* Performs various cytotoxicity tests, including MEM Elution, Direct Contact, Agar Diffusion, MTT Cytotoxicity, XTT Cytotoxicity, and Neutral Red Uptake.
* Specializes in Chemical Characterization and Toxicological evaluation.
**Reputation / proof points**
* Operates modern laboratories.
* Focuses on providing cost-effective solutions.
Additional information
NABI Bio's biocompatibility testing services are designed to meet the requirements of ISO 10993. They emphasize the importance of a Biological Evaluation Plan (BEP) in demonstrating device safety and compliance. The BEP process involves assessing raw materials, packaging, and production conditions to define the appropriate biological testing strategy. Specific cytotoxicity tests, such as MEM Elution and Direct Contact, are detailed with sample requirements and turnaround times of approximately 4 weeks. Buyers should be prepared to provide specific sample quantities and dimensions based on the test method.
Key Highlights
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Specializes in biocompatibility testing for agri-food and biomanufacturing applications.
Source
“NABI Bio is a leading institute in India specializing in agri-food and biomanufacturing. They offer expertise in biocompatibility testing for various applications.”
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Offers comprehensive pre-clinical testing and consulting services for medical devices.
Source
“We offer comprehensive pre-clinical testing and consulting services of medical devices.”
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Conducts a broad range of cytotoxicity tests including MEM Elution, Direct Contact, and Agar Diffusion.
Source
“Cytotoxicity MEM Elution Direct Contact Agar diffusion MTT Cytotoxicity XTT Cytotoxicity Neutral Red Uptake”
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Provides expertise in developing Biological Evaluation Plans (BEP) in accordance with ISO 10993-1.
Source
“Biocompatibility testing data is always required for medical devices with direct and indirect contact. ISO 10993-1:2018 through the Biological Evaluation Plan (BEP) allows to determine the potential risk...”
Certifications & Trust Signals
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Operates modern laboratories.
Source
“We have our own laboratories that are among some of the most modern in all of Europe”
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 biocompatibility testing.
- Companies seeking expertise in Biological Evaluation Plans (BEP).
How engagement typically works
- Consulting and laboratory testing services.
- Focus on cost-effective solutions.
Typical deliverables
- Biocompatibility test reports.
- Biological Evaluation Plans (BEP).
- Cytotoxicity test results.
- Chemical characterization reports.
- Toxicological evaluation reports.
Good to know
- Best when specific sample requirements can be met for testing.
Pricing
Model:
Per project
HQ:
India
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Japan, Europe
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Extractables and Leachables Testing, Toxicological assessments, Biological reactivity tests, Cytotoxicity (MEM Elution, Direct Contact, Agar Diffusion, MTT, XTT, Neutral Red Uptake), Sensitization (GPMT, LLNA, Buehler), In vitro irritation, Intracutaneous reactivity, Animal Irritation Test.
Sample Requirements:
120 cm² (test item < 0.5 mm thick); 60 cm² (test item ≥ 0.5 mm thick); 4 grams; 5 ml
Rush Available:
Yes
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-5
Test Types Offered
Cytotoxicity (MEM Elution, Direct Contact, Agar Diffusion, MTT, XTT, Neutral Red Uptake), Chemical Characterization, Toxicological evaluation
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 4-8 weeks
Quote SLA
4 weeks
Pricing Model
Per project
