Specialist CDMO · Carlsbad, California · Est. 1996
From bench
to batch.
A thirty-year specialist CDMO for ELISA, lateral flow, DFA, and fill-finish — development, scale-up, and manufacturing on the same floor.
The Translator
Most CDMOs are good at development.
We're good at all three.
Most CDMOs fumble the transfer to manufacturing, but ivd Research handles development through scale to manufacturing. We translate lab-stage assays into products that can actually be made at scale.
What separates us is not what we do — it is where we sit in the lifecycle. Development. Scale-up. Manufacturing. Bench to batch. One partner, all the way through.
Bench to batch. One partner, full lifecycle.
96-Well ELISA Plate — Positive Read
lateral flow, DFA, fill-finish
through to batch release
How we work. What you get.
Every engagement routes back to one of these four commitments. Every deck, every page, every conversation.
01
The full arc, one partner.
Bench, transfer, batch, lifecycle. One team through every stage — no handoff risk, no institutional knowledge lost in translation. We wrote the development report. We run the manufacturing floor.
02
Your science, our production.
Customers bring the assay. We bring the floor, the QMS, and the scale. Your IP stays yours. Our job is to build a process that holds — lot to lot, year to year.
03
Designed for production.
Every development decision made with manufacturing in mind from day one. We do not develop first and ask manufacturing questions later. That is where most transfers fail.
04
Capacity that grows with you.
Backed by broader manufacturing relationships. Whether you need early-stage batches or full commercial volume, the scale is there when you are ready for it.
Formats
Four formats.
One specialist team.
ELISA
Enzyme-linked immunosorbent assay development and manufacturing. From antigen-antibody selection through coating chemistry optimisation to validated, repeatable commercial production. Plate to plate. Lot to lot.
Lateral Flow
Point-of-care and near-patient diagnostic strip development, scale-up, and high-volume manufacturing. From membrane chemistry and conjugate optimisation through to finished cassette assembly and fill-finish integration.
Fill-Finish & Kitting
Full kitting and assembly services — configured, labelled, and shipped to your specification. Controlled environment. Documented traceability.
DFA — Direct Immunofluorescence Assay
Direct immunofluorescence assay development, scale-up, and manufacturing. Fluorescent antibody conjugation, substrate optimisation, and validated lot-to-lot production for clinical and point-of-care diagnostic applications.
Quality System
For thirty years, ivd Research has built diagnostic products for some of the most demanding buyers in human health — and not one of them has ever had to explain their requirements twice.
ISO 13485 is not a certificate on the wall. It is the way the floor runs. Design controls, change management, CAPA — built into every process, not bolted on.
Consistency is not a marketing claim. It is the product.
13485
Floor
Team
ivd Journal
Thinking in public.
Featured · November 2018
Scripps Research licenses urine dipstick test for river blindness to IVD Research
"IVD Research, Inc., a contract development and manufacturing (CDMO) firm in Carlsbad, California has licensed a novel biomarker for onchocerciasis—better known as river blindness—from Scripps Research in La Jolla, California. The reagent, developed in the laboratory of Kim Janda, PhD, a professor of chemistry at Scripps Research, will allow clinicians to monitor active infections of onchocerciasis."
Read moreRegulatory
Lateral flow test kits – What are they and how do they work?
"Lateral flow immunoassays have become increasingly popular point-of-care diagnostic tools because they are versatile, easy to use, and provide quick, accurate results without the need for laboratory testing..."
Read moreLearn
What is Fascioliasis? FAQs: Symptoms, diagnosis, treatment, and prevention
"Found in over 50 countries where people engage in sheep and cattle production, fascioliasis is caused by two types of parasitic flatworm..."
Read moreStanding Behind Our Statements
Built around quality.
Not the other way around.
We take our quality policy very seriously — in fact, we've built our entire business model around it. Our vision for the future of ivd Research is to continue to grow upon our existing product offerings, as well as to enter into new markets around the globe by expanding on our already comprehensive quality systems. We strive to improve patient care while developing the next generation in diagnostics.
In addition to being registered by the California and Federal FDA and following cGMP, ivd Research also holds an ISO 13485 certification. Our expert team, solid infrastructure, and respected distributors around the world ensure the highest level of quality, accuracy, and customer service.
Additionally, our sister company KVP SafePath® Laboratories is a USDA Licensed Biologics Manufacturer.
Our Quality Policy
"IVD Research and SafePath® Laboratories will develop, manufacture and sell its own line of in vitro diagnostics which meet or exceed the performance of similar diagnostics in the marketplace — and provide contract development and/or manufacturing services which fulfill customer expectations and requirements. We commit to comply with all applicable ISO 13485:2016, statutory and regulatory requirements, and to maintain the effectiveness of the Quality Management System."
Management Team
Leaders in excellence. Since 1996.
Acquired by KVP International in 2026, ivd Research maintains independent expertise, now with the muscle of a global manufacturer behind it.
A graduate of UC San Diego with a BS in Chemistry, Chris has worked in the biotech industry since 2001.
A graduate of UC San Diego with a BS in Chemistry, Chris has worked in the biotech industry since 2001. He oversees the entire operation including Production, R&D, Quality Assurance, and Regulatory Affairs, while actively pursuing new opportunities for growth.
Founder of IVD Research, Dave has over 40 years' experience in the in vitro diagnostics industry.
Founder of IVD Research, Dave has over 40 years' experience in the in vitro diagnostics industry. He holds a BS in Microbiology from Cal Poly Pomona and a Masters in Business from the University of San Diego. Dave remains actively involved in new product development with the company.
Ann Marie has over 30 years' experience in project management, finance, manufacturing, and customer service.
Ann Marie has over 30 years' experience in project management, finance, manufacturing, and customer service. She holds a BA in Business Administration from the University of Redlands and brings experience from larger biotech companies across San Diego.
Jeran holds a BS in Biology from Francis Marion University and has held roles across manufacturing and R&D in the biotech industry.
Jeran holds a BS in Biology from Francis Marion University and has held roles across manufacturing and R&D in the biotech industry. He has led several successful projects from conception through product transfer and is experienced with FDA 21 CFR and USDA 9 CFR design controls. He remains passionate about developing quality products that meet all customer requirements.
Nancy brings more than 10 years of experience in the biotechnology industry. From holding roles in both manufacturing and quality, Nancy has the ability to maintain adherence to FDA, USDA, and ISO guidelines.
Nancy brings more than 10 years of experience in the biotechnology industry. From holding roles in both manufacturing and quality, Nancy has the ability to maintain adherence to FDA, USDA, and ISO guidelines. While overseeing day-to-day production operations and leading cross-functional teams, Nancy supports the company's mission for growth and delivering innovative solutions.
Diego holds a BS in Biology from the University of the Pacific and brings 20 years of laboratory experience with a focus on manufacturing and quality control.
Diego holds a BS in Biology from the University of the Pacific and brings 20 years of laboratory experience with a focus on manufacturing and quality control. He has been with IVD Research for over 15 years in a variety of roles. As QC Manager, he ensures every product meets USDA and FDA regulations — and the highest possible standards — before release to market.
Erica holds a BS in Biology from the University of California San Diego and began her career as a product development bench scientist, with a background in molecular biology.
Erica holds a BS in Biology from the University of California San Diego and began her career as a product development bench scientist, with a background in molecular biology. She has been in the industry for more than 20 years and spent the past 12 years as a quality assurance consultant across the biotech, medical device, and IVD industries. As QA Manager, she owns the quality management system and its alignment to ISO 13485 and FDA QMSR requirements. She is passionate about building practical quality systems that let teams move quickly without compromising compliance.
Get in Touch
Ready to move your assay to manufacturing?
Talk to a specialist. No NDAs required for the first conversation. We work with teams at every stage — from early development through to commercial batch production.
ivd Research, Inc.