Custom ELISA Kit Development & cGMP Manufacturing
From first feasibility study to CE-IVD-ready commercial production – SeamlessBio delivers full-service ELISA kit CDMO under ISO 13485, backed by in-house biological raw materials and 15+ years of immunoassay expertise.
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One Partner. Research Through Regulated Production.
Developing and manufacturing a custom ELISA kit demands more than assay science – it requires a partner who understands raw material sourcing, regulatory strategy, and scalable production under a certified quality management system.
SeamlessBio is uniquely positioned to take your project from concept to commercial launch. As an established supplier of biological raw materials – including certified human plasma, serum proteins, and BSA for ELISA coating – we control the quality of your key reagents from the first development lot onwards.
Our ISO 13485-certified quality management system and cGMP-capable manufacturing infrastructure allow us to transition seamlessly from research-grade feasibility batches to IVD-compliant commercial production without changing your supplier.
See Our Development ProcessFrom First Discussion to Market-Ready Kit
Every project follows a structured, documented development pathway – giving you full transparency and a clear regulatory paper trail at every stage.
Feasibility & Project Definition
Analyte, matrix, dynamic range, cut-off definition, regulatory intent (RUO / IVD)
2–4 weeksAssay Development & Optimisation
Antibody & antigen sourcing, capture/detection pair screening, blocker & stabilizer optimisation
4–12 weeksAnalytical Validation
Precision, accuracy, linearity, interference, cross-reactivity, stability studies per ISO 17511 / CLSI EP
4–8 weeksTechnology Transfer & Scale-Up
Process transfer to cGMP environment, equipment qualification, batch record generation
4–8 weekscGMP Production & Lot Release
Commercial manufacturing, QC release testing, CoA generation, regulatory documentation package
OngoingELISA Kit Development & Manufacturing Services
Modular service packages – engage us for a single phase or hand the entire project over. We adapt to your team's capabilities and timeline.
Assay Development
Custom sandwich, competitive or indirect ELISA development for any protein, hormone or small molecule analyte.
- Antibody/antigen sourcing & pair screening
- Plate coating & blocking optimisation
- Buffer, blocker & stabiliser selection
- Detection system (HRP, AP, TMB, MSD)
- Calibrator & control matrix development
- Hook-effect & interference studies
cGMP Kit Manufacturing
Commercial-scale production of your validated ELISA kit under full ISO 13485 QMS and cGMP conditions.
- Batch sizes from pilot (50 kits) to commercial scale
- Automated plate coating & reagent dispensing
- In-process controls & release testing
- Full batch record documentation
- Certificate of Analysis (CoA) per lot
- Compliant labeling & packaging (CE-IVD, RUO, ASR)
Regulatory & Quality Support
Comprehensive documentation packages to support your IVD submission – EU IVDR, Health Canada, or FDA 510(k).
- Technical file compilation (EU IVDR Annex II)
- Risk management documentation (ISO 14971)
- Performance evaluation & clinical evidence
- Design history file (DHF)
- Supplier audit & qualification support
- Post-market surveillance strategy
Technology Transfer
Transfer your existing assay into a cGMP-compliant manufacturing process without losing performance.
- Incoming assay characterisation & gap analysis
- Scale-up & process lock
- Equivalence studies vs. donor protocol
- Equipment & process validation (IQ/OQ/PQ)
- Interim supply continuity during transfer
Raw Material Supply Integration
Leverage SeamlessBio's certified biological materials as kit components – removing a key supply chain risk.
- Human serum/plasma for calibrator & control matrix
- BSA (Fraction V, IgG-free) for coating buffers
- Human Serum Albumin (HSA) for blocking
- Species-specific sera for secondary detection
- Full CoA, CoO, TSE/BSE documentation
OEM & White-Label Production
Need an ELISA kit under your own brand? We manufacture, label, and ship – you sell.
- Custom labeling & packaging design
- Your brand, your artwork, our quality
- Kit insert & IFU authoring support
- Drop-shipment & fulfilment options
- Scalable MOQ from 50 to 10,000+ kits/run
Our ELISA Manufacturing Infrastructure
cGMP-capable equipment, controlled environments, and a fully documented quality system – ready for your project from day one.
Analytes & Application Areas
We develop ELISA kits for virtually any protein analyte – if it can be measured by immunoassay, we can build and manufacture the kit.
Cytokines & Inflammation
IL-6, TNF-α, CRP, IL-1β, IFN-γ, calprotectin, ferritin
Cardiovascular Markers
Troponin I/T, NT-proBNP, BNP, D-Dimer, FABP
Oncology Biomarkers
PSA, CEA, CA-125, AFP, HER2, VEGF, PD-L1
Infectious Disease Serology
IgG/IgM seroprevalence, antigen detection, neutralisation
Hormones & Endocrinology
TSH, T3/T4, insulin, cortisol, estradiol, testosterone
Drug Monitoring (TDM)
Biologics TDM, anti-drug antibodies (ADA), small molecule drugs
Veterinary Diagnostics
Canine, feline, equine, bovine – species-specific assay development
Food & Environmental
Allergen detection, mycotoxins, pesticide residues, contaminants
Built for Regulated Markets
ISO 13485:2016
Certified QMS for design, development, and manufacturing of in vitro diagnostic devices
EU IVDR 2017/746
Technical file and performance evaluation support for CE-marking under the new IVDR framework
Health Canada / FDA Compatible
Documentation packages structured for Canadian MDEL/IVD and US FDA 510(k) or De Novo pathways
The Integrated Advantage You Won't Find Elsewhere
Most ELISA CDMOs source their biological raw materials from third-party suppliers – introducing a dependency that affects lot consistency, documentation quality, and lead times. SeamlessBio eliminates this gap.
| Capability | SeamlessBio | Typical ELISA CDMO | Large CRO / Biotech |
|---|---|---|---|
| ISO 13485 cGMP manufacturing | ✓ Certified | ✓ | ✓ |
| In-house biological raw material supply | ✓ Full portfolio (human plasma, BSA, HSA, sera) | ✗ Third-party only | ~ Partial |
| R&D through commercial scale – one supplier | ✓ Single QTA across all phases | ~ Split between partners | ~ Often split |
| EU regulatory expertise (CE-IVD / IVDR) | ✓ Native EU expertise, Made in Germany | ~ Varies | ✓ |
| Health Canada / North America documentation | ✓ Experience with Canadian IVD requirements | ~ Varies | ✓ |
| Small & mid-size batch flexibility | ✓ MOQ from 50 kits | ~ Often high MOQ | ✗ High MOQ / long lead times |
| Dedicated project contact | ✓ Named project manager throughout | ~ Varies | ✗ Account manager rotation |
| White-label OEM production | ✓ Your brand, our manufacturing | ✓ | ✗ Rarely offered |
"We had an assay that worked beautifully in the lab but couldn't survive the transition to cGMP manufacturing. SeamlessBio fixed the root cause – a raw material variability issue – because they supplied the blocker themselves."IVD Development Director European Diagnostics Company (reference available on request)
ELISA Kit CDMO – Your Questions Answered
What information do you need to provide a project quote?
To generate a meaningful proposal we typically need:
- Target analyte(s) and sample matrix (serum, plasma, urine, etc.)
- Intended use – Research Use Only (RUO), ASR, or IVD (CE marking, FDA, Health Canada)
- Required sensitivity/dynamic range (if known)
- Existing IP, antibodies, or assay protocols you own
- Target batch sizes and annual volume estimates
Don't worry if you don't have all details – our initial consultation is designed to clarify requirements together.
Can you develop an ELISA kit if we already have our own antibodies?
Yes – we regularly work with client-supplied antibodies or antigens. We sign a Mutual NDA and Material Transfer Agreement (MTA) at the outset. Our team will characterise your material, integrate it into our development workflow, and formulate it appropriately for cGMP production. Your IP remains entirely yours.
What is the minimum order quantity (MOQ) for cGMP kit production?
We offer flexible batch sizes starting from 50 kits per run, which is ideal for clinical evaluation, early commercialisation, or market seeding phases. For commercial supply, standard run sizes range from 200–2,000 kits per batch. Larger volumes are available on request with lead time planning.
How does SeamlessBio support CE-IVD marking under EU IVDR?
Our quality system is ISO 13485:2016 certified – the prerequisite for CE-IVD manufacturing. We support technical file compilation (IVDR Annex II/III), performance evaluation documentation, risk management files (ISO 14971), and clinical evidence packages. For Class C/D devices, we can facilitate the Notified Body interface. We are not a Notified Body ourselves but work closely with accredited NB partners.
We are a Canadian company. Can you comply with Health Canada requirements?
Yes. Health Canada's IVD licensing framework (under the Medical Devices Regulations, SOR/98-282) recognises ISO 13485 as the basis for the Quality Management System requirement. Our cGMP manufacturing and documentation standards are aligned with Health Canada IVD Class II/III requirements. We have experience supplying Canadian diagnostics companies and can provide a free-sale certificate issued by German competent authorities (BfArM-equivalent) as part of the documentation package.
Do you offer raw material supply as part of the kit manufacturing agreement?
Yes – this is one of our key differentiators. SeamlessBio supplies certified biological materials (human plasma, serum, BSA, HSA, species-specific sera) that can be embedded directly into your kit as calibrator matrix, diluent, or blocking components. All raw materials come with full CoA, CoO, TSE/BSE documentation, and are sourced under our ISO 13485 QMS. This eliminates a supply chain dependency that often causes lot-to-lot variability in competitor kits.
What is the typical timeline from project start to first commercial lot?
Timelines depend heavily on assay complexity, starting point (novel vs. existing assay), and regulatory target. As a general guide:
- RUO kit (existing assay, technology transfer only): 12–18 weeks
- Novel assay development to RUO release: 6–9 months
- Full development + CE-IVD technical file: 9–18 months
We provide detailed Gantt charts and milestone plans at project kickoff.
Can SeamlessBio also help with multiplexed or automated platform ELISA?
Yes. In addition to standard 96-well plate ELISAs, we have experience with MSD (Meso Scale Discovery) electrochemiluminescence multiplex assays and can advise on format migration from standard ELISA to automated platforms (e.g. BRAHMS KRYPTOR, LIAISON, VIDAS). Contact us to discuss your specific platform requirements.
Integrated Raw Material Supply for Your ELISA Kit
Ready to Discuss Your ELISA Kit Project?
Whether you have a fully developed assay ready for GMP transfer, or just an analyte and a market in mind – our team is ready to map out the path forward.