Maxim BiomedicalInnovation for a
Healthier World

Contract Assay Development & Manufacture

Our structured process is a path to success

We partner with our customers to understand their development and manufacturing needs while planning for the full product lifecycle. Contact us to make your next product launch a success.

Automated Manufacturing


MaximBio 27,000 square foot facility offers OEMs and governmental agencies the latest automated manufacturing capabilities and is completely equipped with an in-house biochemistry lab.

We’re an industry leading and trusted source for assay development and manufacture, enabling many of today’s diagnostic tests. Whether you a single innovative idea or need to scale up manufacturing, we have the experience and ability to help. From concept to commercialization, our world-class team of scientists and engineers bring a wealth of knowledge to be the partner for every stage of your development.


With decades of experience in developing and commercializing diagnostic assays, MaximBio has unique experience in creating products for a wide range of applications and markets, including for the point-of-care (POC) and over-the-counter (OTC) settings.

Our design processes emphasize a deep understanding of the specific market needs and manufacturing scale up to ensure your products are ready for commercialization.

Our specialties include:

  • ​Lateral flow assay (LFA) development and manufacture
  • Single and multiplex assays
  • Qualitative and quantitative assays
  • Visual and fluorescent labels
  • Reader or non-reader based platforms
  • Cassette and dipstick formats
  • Enzyme-linked immunosorbent assays (ELISA) development and manufacture​​
  • Qualitative and quantitative assays
  • Competitive and sandwich tests
  • HRP and AP conjugations
  • Buffer preparations


MaximBio provides turnkey manufacturing services to provide you with a customized solution to fit your needs for cost-effective, low to high volume production processes.

​We offer seamless, flexible, and scalable processes in our FDA cGMP and ISO13485 manufacturing facility. Whether you are looking for small research batches or high-volume manufacturing of millions of units, MaximBio has expertise you need.

Our specialties include:

  • Lateral flow assay (LFA) manufacture
  • Batch and Reel-to-Reel
  • Various nanoparticles and labels conjugation
  • Buffer preparation
  • Assembly and packaging
  • Enzyme-linked immunosorbent assays (ELISA) manufacture​​
  • Automatic plate-coating
  • Various enzymes conjugation
  • Buffer preparation
  • Assembly and packaging

Turnkey Manufacturing Infrastructure

Full scale manufacturing from lots in the thousands to over 4MM devices per week. Flexible service offerings tailored to your needs

Lateral Flow Immunoassays (LFI)

Test Technologies

  • Single and Multiplex Assays
  • Visual and Fluorescent Labels
  • Reader and Non-Reader Platforms
  • Dipstick and Cassette Formats

Sample Types

  • Nasal / Nasopharyngeal Swab
  • Fingerstick Blood
  • Urine
  • Saliva / Oral Swab
  • Venous Blood / Serum / Plasma
Enzyme-Linked Immunosorbent Assays (ELISA)


  • Qualitative and Quantitative Assays
  • Competitive and Sandwich
  • Assays Color Substrate and Fluorescent (CLIA)
  • Assay Buffer Design and Manufacturing
  • Batch and Automated Manufacturing
Buffer Prep & Filling

  • Up to 1,000L Batch Buffer Manufacturing
  • Semi-automated and Automated Filling
  • μL to L Filling Size Capability
  • ISO 5 & ISO 7 Clean Rooms Filling

Let’s Team up and Bring your
innovation to Life!