Diagnostics

Small and medium-sized biotechnology businesses frequently have to make hard decisions concerning whether the materials and methods they utilize should be for good manufacturing practice (GMP) compliance or research use only (RUO). 

The acquisition of raw materials and starting materials to the implementation of quality management systems are only a few of the many obstacles and challenges to overcome while designing biologic manufacturing processes for diagnostic products. As a result, our goal at Cell Culture Company is to be a dependable partner to biotech companies and help them prepare strategies for using RUO and GMP materials and products in the development of biologics studies and processes.

GMP and Non-Classified RUO Production

GMP, or good manufacturing practices, is the term for a system that makes sure every product is manufactured in a way that provides quality and traceability. For biotech businesses, it refers to the rules and regulations that oversee how medicines and other treatment modalities are produced in a way that is regulated, repeatable, and adheres to quality standards. In other words, GMP specifies the best practices that a business should adhere to when developing and manufacturing products.

The label ” Research Use Only” (RUO) in laboratory products indicates that the product is not intended for use in diagnostic procedures. It indicates that the products are hardly ever subject to any regulatory oversight. Because of this, they are popular substitutes for more expensive and time-consuming in-vitro diagnostic products.

Cell Culture Company offers GMP and unclassified RUO manufacturing options with reasonable prices scaled based on project size and requirements. We offer solutions for a special supply agreement structure with fixed pricing, safety stock, and just-in-time shipment for all GMP and Non-Classified (RUO) products that your business requires.

Why Choose Cell Culture Company

Cell Culture Company offers more than 40 years of experience with more than 2,500 different cell lines and 1,700 researchers. Our operations, innovation, and experience are concentrated on increasing yields, ensuring batch consistency, and reducing manufacturing costs to help biotech companies in their research and diagnostics.

Our main goal has been to help research through commercialization by offering the best solutions. We support medicinal, pre-clinical, animal health, food safety, genomics, diagnostic, and genomic-based businesses. With our GMP-compliant, ISO 9001:2015 Certification manufacturing facility, you’ll have peace of mind knowing you’re working with a reliable and trustworthy GMP and Non-Classified RUO production company.

Contact us today for your diagnostic production needs.