Your ELISA.
Built to Perform.
Krishgen BioSystems develops high-performance custom ELISA, immunoassays, ADA, and PK assays for pharma and biopharma — validated to FDA guidelines, delivered on time.
Custom Assay & ELISA Development Services
End-to-end immunoassay development across a wide range of technologies, species, and matrices — tailored to your exact research needs.
Custom ELISA Development
Full assay design and development for novel or uncommon targets. Sandwich, competitive, and indirect ELISA formats. We source antibodies, develop proprietary diluents, and optimize signal-to-noise ratios.
Core ServiceELISA Optimization & Re-Validation
Improve sensitivity, specificity, or adapt an existing assay to a new sample matrix or automation platform. Rapid turnaround — re-optimizations delivered in as little as 15 days.
Fast TurnaroundAnti-Drug Antibody (ADA) Assays
Immunogenicity testing for biosimilars and novel biologics. Validated ADA and neutralizing antibody (NAb) assays designed per FDA/EMA immunogenicity guidance and ICH M10.
Regulatory-ReadyPharmacokinetic (PK) Assays
Krishgen holds the world's largest range of ELISA for PK studies of monoclonal antibody drugs — spanning 350+ targets. Custom PK assays developed to your specifications.
350+ mAb TargetsMatrix & Species Adaptation
Adapt any ELISA to a new sample matrix — serum, plasma, tissue homogenate, cell culture supernatant — or to a new species. Includes diluent reformulation and cross-reactivity assessment.
Any Matrix / SpeciesBioassay Validation & Transfer
Pre-validation and full validation per US FDA ICH M10 and EMA bioanalytical guidelines. Complete technology transfer packages with documentation to your specifications.
FDA ICH M10Sample Testing Services
Run your study samples through our validated assays. Suitable for large multi-site clinical studies requiring consistent assay performance over time. Full data and reporting included.
Results in 90–120 DaysELISA Kit Manufacturing
Once your assay is developed, we manufacture it as a complete ELISA kit — in any lot size required — for ongoing use in your lab or commercial distribution.
ScalableThe Krishgen Advantage
A complete solution partner — from initial feasibility to tech transfer — with transparency at every step.
Total Solution Architects
From total tech transfer to targeted optimisation — we adapt to your needs across any species, sample type, or regulatory requirement.
Transparent Milestone Pricing
Competitive costs with a 50% upfront structure and milestone-based payments. No hidden fees. Detailed proposals including feasibility assessment and realistic timelines.
Proprietary In-House Solutions
Our diluents and blocking solutions — developed and perfected over 13+ years — deliver optimal signal-to-noise ratios and robust, reproducible ELISA results.
Regulatory-Ready Documentation
Validation reports, tech transfer packages, and final data reports prepared to your specifications and in line with FDA ICH M10 requirements.
State-of-the-Art Lab Infrastructure
Four application labs plus an ISO 13485 certified production lab. Equipped with Dynex automated ELISA processors, Luminex multiplexing, Tecan readers, and more.
"The advantage of using services from Krishgen is that they are old players in this industry and have developed hundreds of unique immunoassays. They are able to offer expert solutions for every concern."
— Vice President, Major Biosimilar Company
Assay Technologies We Work With
Simple, Transparent Workflow
From first contact to final tech transfer — here's exactly how your project progresses with Krishgen.
Initial Discussion
Our team reaches out promptly. A brief intake form helps us understand your project context before we dive in.
Technical Consultation
A detailed call with our senior scientists to map your assay requirements, species, matrix, and regulatory needs.
Proposal & Agreement
Full scope, cost breakdown, and timeline. 50% advance to begin — no hidden fees, no surprises.
Development
Pilot runs and full assay development commence. We update you at each defined milestone.
Milestone Reporting
Raw data, progress updates, and feedback windows at every stage before we proceed.
Final Report & Transfer
Validation report, all data, and complete tech transfer package delivered to your specifications.
Custom Assay Case Studies
Real projects. Measurable outcomes. See how Krishgen has accelerated development timelines for pharma clients worldwide.
Degarelix ELISA — US-Based Pharma Company
A US pharma company needed a Degarelix ELISA validated to FDA guidelines for plasma, for biosimilar lot comparison. No commercial kit existed.
Delivered in <90 daysEculizumab ELISA — Spanish Pharma Company
A Spanish pharma required greater sensitivity in their existing Eculizumab assay plus reagent optimization for their automation platform.
Re-optimized in 15 daysDaratumumab ELISA — US CRO
A US CRO needed Daratumumab ELISA calibrated to a unique, viscous sample matrix — requiring custom diluents and alternative buffers.
Calibrated in 60 daysNovel Marker ELISA — US Nano-Medicine Company
A nano-medicine pharma company developed a brand new biomarker with no commercial assay available. Multiple validated kit lots needed over 24 months.
Multi-lot delivery, 24 monthsReady to Build Your Custom Assay?
Send us a brief overview of your project — our team will respond within one business day with a tailored proposal.
Request a Free Proposal