About Us

Check out our new website at www.floridabiologix.ufl.com.

Florida Biologix® is a non-profit biopharmaceutical development and manufacturing service provider that fills the biotechnology industry's unmet need for cGMP biopharmaceutical production and testing. We provide process development, clinical trial material production, and many support services to the biotechnology industry and biomedical research institutions.

Our primary focus is to produce cGMP compliant clinical trial material on time and at a reasonable price.

We offer a full range of manufacturing and testing services in a state-of-the-art facility. Our new, 23,000 sq. ft. validated, multi-product facility has been designed and built with best-in-class process and support equipment to provide timely, low cost, high-quality, cGMP compliant Phase I and Phase II contract manufacturing and testing services.

"We have partnered with Florida Biologix in developing, manufacturing and testing several banks and Phase I clinical lots over the past eighteen months. They have adapted quickly to meet the changing needs of the project as it progressed. Their technical expertise and effective communication have enabled us to get past a few potential hurdles. We have a great working relationship and will continue to partner with Florida Biologix for future projects." -- Biotech client from CA

"This was a difficult project and we appreciated the help" --Dan Orenzuk, Pharmacist

Our services include (but are not limited to):

  • Cell line engineering
  • cGMP cell banking
  • Upstream and downstream processes design
  • Process and assay development
  • cGMP production of proteins expressed in mammalian cells (including monoclonal antibodies, recombinant proteins, enzymes, vaccines and other biomolecules)
  • Purification
  • Aseptic filling (including small molecules, nucleic acids and proteins)
  • Cell therapy products
  • Product testing and regulatory support.

Flexibility in scheduling and production
At Florida Biologix, we are very conscious of your budget and time constraints. Our facility was designed from the ground up for the manufacture of multiple products. This enables us to have flexibility in scheduling so that your project can be started and completed on time. We are equipped to produce cGMP Phase I and II biopharmaceutical clinical trial material as well as non-cGMP products.

The most experienced team to manage the project every step of the way
Our technical managers have over 100 years of combined biopharmaceutical manufacturing experience. Simply put, we can deliver. The expert knowledge of our cGMP manufacturing team allows us to give you the product you specified, on time and within budget.

Highest quality at a competitive price
Quality is paramount in our business, and you will find it at every level of our organization. Our in-house Quality Control and Quality Assurance teams means that your product will be appropriately characterized tested and released for use in the clinic. We also support CMC and DMF preparation. Our operational model, location and affiliations help to keep costs low and we pass this savings to you.

We encourage you to visit our facilities, meet our staff, see our capabilities and audit our processes

We meet your outsourcing needs quickly and cost-effectively; accomplishing your goal of moving biologics from bench to clinic.

Click here for a video walk-through of our facility

Florida Biologix is NOT just another University Affiliated cGMP facility. Learn Why.