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Biosafety Testing Laboratory

Name: Biosafety Testing Laboratory
Brand: Minaris
Availability: MadeToOrder

Certificates:ISO/IEC 17025:2017 accreditationFDA drug establishment registrationEMA GMP certificatesPMDA GMP certificates+2 more

MARTANDAYA MINARIS PRIVATE LIMITEDNorth West Delhi, DL

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Brand Minaris

Price on request

MOQ 1 1 dayCurrency INR

Estimated delivery by 9 Jul 2026

Customization for this product

null

BharatSeal order protection

Secure payments

Every payment is processed via Razorpay with PCI-DSS data protection and SSL encryption. We never see your card details.

PayUPIVisaMCAmexRuPayNet BankingWalletsPay Later+ more

Money-back protection

Claim a refund if your order doesn't ship, arrives damaged, or doesn't match the agreed spec. Disputes resolved within 7 working days.

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Service

1-day production

Standard lead time once order is confirmed.

Highlights at a glance

✓Brand: Minaris
✓Category: Services
✓Made in North West Delhi, DL, India
✓Minimum order: 1 units
✓Lead time: 1 day
✓Certified: ISO/IEC 17025:2017 accreditation, FDA drug establishment registration, EMA GMP certificates

About this item

Comprehensive biosafety, viral clearance, and potency testing for mAbs, viral vaccines, and advanced therapies.
Over 40 years of biosafety expertise, providing GMP-compliant sterility, mycoplasma, endotoxin, adventitious agent and replication-competent virus testing.
Risk-based strategies tailored to viral vectors, plasmids and packaging systems.
Results are audit-ready and regulator-accepted, supporting IND, IMPD and BLA submissions worldwide.
ICH Q1-compliant stability programs, including long-term, real-time, accelerated and ongoing studies.
Global leader with 3,000+ studies and zero regulatory rejections in viral clearance studies aligned with ICH Q5A(R2), FDA, EMA and WHO guidelines.

Description

Comprehensive biosafety, viral clearance, and potency testing for mAbs, viral vaccines, and advanced therapies.

Analytical Development

Our analytical scientists design, optimize and validate assays across the full lifecycle, from early-phase methods to commercial readiness. Services include potency, purity, identity and stability testing, aligned with ICH Q2 and global regulatory expectations. Integrated with development and manufacturing, we ensure reliable GMP performance across all modalities.

Assay Transfer

Smooth assay transfer ensures continuity and reliability across sites and studies, maintaining consistency and accuracy. We deliver structured, data-driven transfers, including gap analysis, bridging studies and qualification/validation, in accordance with ICH Q2. Methods are supported across viral vectors, gene-edited cells, monoclonal antibodies (mAbs), proteins and vaccines, ensuring seamless readiness for lot release, stability and comparability studies.

Biosafety Testing

With more than 40 years of biosafety expertise, Minaris provides GMP-compliant sterility, mycoplasma, endotoxin, adventitious agent and replication-competent virus testing. Our specialized focus on CGT ensures risk-based strategies tailored to viral vectors, plasmids and packaging systems. Results are audit-ready and regulator-accepted, supporting IND, IMPD and BLA submissions worldwide.

Cell Line Characterization

We provide comprehensive, regulatory-compliant characterization of Master, Working and End-of-Production Cell Banks, including sterility, mycoplasma, endotoxin, retroviral and identity testing. Our services align with the guidelines of the ICH, FDA, EMA and PMDA, enabling the faster release of GMP cell banks and seamless integration into development and manufacturing workflows.

Lot Release

A reliable lot release ensures that therapies reach patients without delay. Minaris provides a comprehensive GMP testing panel across various modalities, including sterility, identity, potency, purity, residuals, RCL/rcAAV and more. With thousands of batches tested, our validated assays support global submissions and commercial approvals, minimizing risk and accelerating patient access.

Potency

Potency is a critical quality attribute. We design and validate custom assays, ranging from cell-based functional studies and reporter gene assays to ELISA, PCR and transduction efficiency tests. All assays meet ICH Q2 standards, providing meaningful biological insights that satisfy regulators and support product release and lifecycle management.

Stability

We deliver ICH Q1-compliant stability programs, including long-term, real-time, accelerated and ongoing studies. Our methods support all biologic and advanced therapy modalities, with submission-ready data for global regulators. By evaluating shelf life and storage conditions, we ensure that therapies maintain their safety, quality and efficacy throughout distribution and patient use.

Viral Clearance

A global leader with 3,000+ studies and zero regulatory rejections, Minaris designs viral clearance studies aligned with ICH Q5A(R2), FDA, EMA and WHO guidelines. Dedicated viral clearance suites with AKTA systems ensure rigorous validation across vectors, proteins and vaccines, safeguarding patient safety and accelerating regulatory approvals.

Key attributes

Category	Services
Brand	Minaris
Place of origin	North West Delhi, DL, India
Minimum order	1 units
Lead time	1 day
Dimensions	1.23 × 1.23 × 1.23 null
Weight	1.23 kg

Packaging & delivery

Carton size	1.23 × 1.23 × 1.23 null
Gross weight per unit	1.23 kg

Certificates

ISO/IEC 17025:2017 accreditation

FDA drug establishment registration

EMA GMP certificates

PMDA GMP certificates

TGA GMP certificates

MFDS GMP certificates

USDA registration

Reviews

Questions & answers

Ask the supplier — answers are visible to all buyers

No questions yet. Be the first to ask!

Know your supplier

MARTANDAYA MINARIS PRIVATE LIMITED

Unverified<1 yr on BharatSealNorth West Delhi, Delhi

Orders completed

—

On-time delivery

—

Reorder rate

—

Year founded

2025

Staff size

—

Certifications

Company profile More products

Biosafety Testing Laboratory

Certificates:ISO/IEC 17025:2017 accreditationFDA drug establishment registrationEMA GMP certificatesPMDA GMP certificates+2 more

MARTANDAYA MINARIS PRIVATE LIMITEDNorth West Delhi, DL

Storefront →

Brand Minaris

Price on request

MOQ 1 1 dayCurrency INR

Estimated delivery by 9 Jul 2026

Customization for this product

null

BharatSeal order protection

Secure payments

Every payment is processed via Razorpay with PCI-DSS data protection and SSL encryption. We never see your card details.

PayUPIVisaMCAmexRuPayNet BankingWalletsPay Later+ more

Money-back protection

Claim a refund if your order doesn't ship, arrives damaged, or doesn't match the agreed spec. Disputes resolved within 7 working days.

Trade Assurance — not yet enrolled by this seller

This seller has not yet activated Trade Assurance. Pay outside BharatSeal at your own risk — we recommend chatting first to verify.

Only orders placed and paid through BharatSeal can enjoy free protection by 🛡 BharatSeal Trade Assurance.

Service

1-day production

Standard lead time once order is confirmed.

Highlights at a glance

✓Brand: Minaris
✓Category: Services
✓Made in North West Delhi, DL, India
✓Minimum order: 1 units
✓Lead time: 1 day
✓Certified: ISO/IEC 17025:2017 accreditation, FDA drug establishment registration, EMA GMP certificates

About this item

Comprehensive biosafety, viral clearance, and potency testing for mAbs, viral vaccines, and advanced therapies.
Over 40 years of biosafety expertise, providing GMP-compliant sterility, mycoplasma, endotoxin, adventitious agent and replication-competent virus testing.
Risk-based strategies tailored to viral vectors, plasmids and packaging systems.
Results are audit-ready and regulator-accepted, supporting IND, IMPD and BLA submissions worldwide.
ICH Q1-compliant stability programs, including long-term, real-time, accelerated and ongoing studies.
Global leader with 3,000+ studies and zero regulatory rejections in viral clearance studies aligned with ICH Q5A(R2), FDA, EMA and WHO guidelines.

Description

Comprehensive biosafety, viral clearance, and potency testing for mAbs, viral vaccines, and advanced therapies.

Analytical Development

Our analytical scientists design, optimize and validate assays across the full lifecycle, from early-phase methods to commercial readiness. Services include potency, purity, identity and stability testing, aligned with ICH Q2 and global regulatory expectations. Integrated with development and manufacturing, we ensure reliable GMP performance across all modalities.

Assay Transfer

Smooth assay transfer ensures continuity and reliability across sites and studies, maintaining consistency and accuracy. We deliver structured, data-driven transfers, including gap analysis, bridging studies and qualification/validation, in accordance with ICH Q2. Methods are supported across viral vectors, gene-edited cells, monoclonal antibodies (mAbs), proteins and vaccines, ensuring seamless readiness for lot release, stability and comparability studies.

Biosafety Testing

With more than 40 years of biosafety expertise, Minaris provides GMP-compliant sterility, mycoplasma, endotoxin, adventitious agent and replication-competent virus testing. Our specialized focus on CGT ensures risk-based strategies tailored to viral vectors, plasmids and packaging systems. Results are audit-ready and regulator-accepted, supporting IND, IMPD and BLA submissions worldwide.

Cell Line Characterization

We provide comprehensive, regulatory-compliant characterization of Master, Working and End-of-Production Cell Banks, including sterility, mycoplasma, endotoxin, retroviral and identity testing. Our services align with the guidelines of the ICH, FDA, EMA and PMDA, enabling the faster release of GMP cell banks and seamless integration into development and manufacturing workflows.

Lot Release

A reliable lot release ensures that therapies reach patients without delay. Minaris provides a comprehensive GMP testing panel across various modalities, including sterility, identity, potency, purity, residuals, RCL/rcAAV and more. With thousands of batches tested, our validated assays support global submissions and commercial approvals, minimizing risk and accelerating patient access.

Potency

Potency is a critical quality attribute. We design and validate custom assays, ranging from cell-based functional studies and reporter gene assays to ELISA, PCR and transduction efficiency tests. All assays meet ICH Q2 standards, providing meaningful biological insights that satisfy regulators and support product release and lifecycle management.

Stability

We deliver ICH Q1-compliant stability programs, including long-term, real-time, accelerated and ongoing studies. Our methods support all biologic and advanced therapy modalities, with submission-ready data for global regulators. By evaluating shelf life and storage conditions, we ensure that therapies maintain their safety, quality and efficacy throughout distribution and patient use.

Viral Clearance

A global leader with 3,000+ studies and zero regulatory rejections, Minaris designs viral clearance studies aligned with ICH Q5A(R2), FDA, EMA and WHO guidelines. Dedicated viral clearance suites with AKTA systems ensure rigorous validation across vectors, proteins and vaccines, safeguarding patient safety and accelerating regulatory approvals.

Key attributes

Category	Services
Brand	Minaris
Place of origin	North West Delhi, DL, India
Minimum order	1 units
Lead time	1 day
Dimensions	1.23 × 1.23 × 1.23 null
Weight	1.23 kg

Packaging & delivery

Carton size	1.23 × 1.23 × 1.23 null
Gross weight per unit	1.23 kg

Certificates

ISO/IEC 17025:2017 accreditation

FDA drug establishment registration

EMA GMP certificates

PMDA GMP certificates

TGA GMP certificates

MFDS GMP certificates

USDA registration

Reviews

Questions & answers

Ask the supplier — answers are visible to all buyers

No questions yet. Be the first to ask!

Know your supplier

MARTANDAYA MINARIS PRIVATE LIMITED

Unverified<1 yr on BharatSealNorth West Delhi, Delhi

Orders completed

—

On-time delivery

—

Reorder rate

—

Year founded

2025

Staff size

—

Certifications

Company profile More products

Biosafety Testing Laboratory

Service

Highlights at a glance

About this item

Description

Analytical Development

Assay Transfer

Biosafety Testing

Cell Line Characterization

Lot Release

Potency

Stability

Viral Clearance

Key attributes

Packaging & delivery

Certificates

Reviews

Questions & answers

Know your supplier

More from Martandaya Minaris

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Biosafety Testing Laboratory

Service

Highlights at a glance

About this item

Description

Analytical Development

Assay Transfer

Biosafety Testing

Cell Line Characterization

Lot Release

Potency

Stability

Viral Clearance

Key attributes

Packaging & delivery

Certificates

Reviews

Questions & answers

Know your supplier

More from Martandaya Minaris

Cell & Gene Therapy CDMO

Similar products from other suppliers

Vmc Machine Job Work

Rapid Prototyping

Online 3D Printing

Design Services

Post Processing

CNC Machining Services

CMM Inspection Services

FRP Lining Services