Custom Manufacturing Center

Quality Microbial Growth and Preservation
Lexington, KY

We have extensive custom manufacture capabilities for bacteria/fungi, parasites, phage, and nucleic acids in virtually any form. Our versatile manufacturing capabilities allows us to design and produce customized solutions that alleviate your unique challenges.These bio-materials are available in a variety of formats, concentrations, strain combinations and applications. In addition, we also provide clinical isolates for your proficiency testing needs.

Learn more about our Lexington services:

Certifications and Registrations

ISO Certified and FDA Registered

We provide services and manufactured products in
accordance with a sound quality management system.
Registration with the FDA provides evidence that
Microbiologics adheres to all Current Good
Manufacturing Practices (CGMP.)

ISO 13485:2016 (Registration # MD19.8005, The National Standards Authority of Ireland (NSAI))

  • Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
  • The principal standard for manufacturers of medical products, devices and components.
  • A testament to the manufacturer's quality management system and their ability to consistently design, develop, produce and distribute in-vitro microorganism preparations of the highest quality.

Food and Drug Administration Establishment (Registration #: 1050138)

  • Applies to the facility, methods and controls used for the design, purchase, manufacture, packaging, labeling, storage and distribution of in-vitro medical diagnostic products.
  • Ensures that finished products are safe, effective and in compliance with Federal Food and Drug and Cosmetic Act.

Contact the Lexington Team

We’re ready to answer your questions.

Microbiologics Custom Manufacturing Center
1040 Manchester Street
Lexington, KY 40508

USA Toll Free: +1.800.599.2847
businessdevelopment@microbiologics.com

Contact Us

We are the world’s leading experts and go-to collaborators for biological products and services.

Learn more about our capabilities and areas of expertise at each of our locations.