Custom Manufacturing Services
Custom Manufacturing Services
From milligrams to kilograms, Enzo Life Sciences provides custom manufacturing of antibodies, proteins, ELISA kits, small molecules, and biochemicals. Our FDA-registered, ISO 13485 facility delivers pharmaceutical-grade quality for research, diagnostic, and therapeutic applications.
Manufacturing Capabilities
Comprehensive production services across multiple product categories
GMP Manufacturing
FDA-registered facility with cGMP compliance for production of IVD components, diagnostic reagents, and clinical-grade materials. Full documentation and batch records.
Antibody Production
Custom monoclonal and polyclonal antibody production, purification, conjugation, and formulation. From immunization through final QC release testing.
ELISA Kit Assembly
Custom ELISA kit development and manufacturing — from assay design through scale-up, validation, plate coating, and final kit assembly with QC testing.
Small Molecule Synthesis
Custom synthesis and scale-up of small molecules, enzyme substrates, fluorescent probes, and biochemical reagents to your specifications.
Protein Expression
Recombinant protein expression in bacterial, yeast, insect, and mammalian systems. Purification, refolding, and formulation to your specifications.
Custom Conjugation
Conjugation of antibodies, proteins, and peptides to enzymes (HRP, AP), fluorochromes, biotin, and custom labels. Optimized protocols for each substrate.
Quality Systems & Certifications
Manufacturing Process
Our structured manufacturing process ensures consistent quality and on-time delivery:
- Feasibility Assessment — We evaluate your requirements and provide a detailed technical proposal with timeline and cost estimate
- Development & Optimization — Our scientists optimize formulation, assay conditions, and manufacturing parameters to meet your specifications
- Scale-Up & Validation — Process transfer from development to manufacturing scale with IQ/OQ/PQ validation as required
- Production & QC — Full-scale manufacturing with in-process controls and final release testing per agreed specifications
- Packaging & Labeling — Custom packaging, labeling, and documentation per your branding and regulatory requirements
- Ongoing Supply — Dedicated manufacturing capacity with safety stock management and scheduled production runs
Manufacturing by the Numbers
Customer Testimonials
“Enzo has been our custom ELISA kit manufacturing partner for over a decade. Their quality systems, technical expertise, and reliable supply chain have been critical to our diagnostic product line.”
VP of Operations
“We needed a GMP manufacturer for our clinical-grade antibody conjugates. Enzo delivered on specifications, timeline, and documentation requirements from the very first batch.”
Director of Manufacturing
“The transition from R&D-scale to manufacturing-scale was seamless. Enzo assigned dedicated project managers and scientists who understood both our product and our regulatory requirements.”
Head of Procurement
“Enzo has been our custom ELISA kit manufacturing partner for over a decade. Their quality systems, technical expertise, and reliable supply chain have been critical to our diagnostic product line.”
VP of Operations
“We needed a GMP manufacturer for our clinical-grade antibody conjugates. Enzo delivered on specifications, timeline, and documentation requirements from the very first batch.”
Director of Manufacturing
“The transition from R&D-scale to manufacturing-scale was seamless. Enzo assigned dedicated project managers and scientists who understood both our product and our regulatory requirements.”
Head of Procurement
Start Your Custom Manufacturing Project
Contact our manufacturing team to discuss your project requirements. We provide detailed proposals with pricing, timelines, and technical specifications — typically within 5 business days.