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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
Anchored to the MCA registerCIN U23999DL2023PTC420901
Brand Minaris
Price on request. Ask the factory for a quote.
MOQ 1 1 dayCurrency INR
Estimated delivery in about 6 days
Customization for this product
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Key attributesAll specs
Category
Biosafety
Brand
Minaris
Min. order
1 units
Lead time
1 day
Place of origin
North West Delhi, DL, India

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

CategoryServices
BrandMinaris
Place of originNorth West Delhi, DL, India
Minimum order1 units
Lead time1 day
Dimensions1.23 × 1.23 × 1.23 null
Weight1.23 kg

Packaging & delivery

Carton size1.23 × 1.23 × 1.23 null
Gross weight per unit1.23 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

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Know your supplier

MARTANDAYA MINARIS PRIVATE LIMITED
Unverified<1 yr on BharatSealNorth West Delhi, Delhi
Year founded
2025
Certifications
7

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