Advanced quality GMP Grade mRNA raw materials for therapeutic manufacturing

Roche fit-for-purpose and GMP Grade mRNA raw materials and reagents

Safety and security at the heart of every product

For over 30 years, we have been a valued partner of therapeutic manufacturers, completing 150 projects to develop and produce enzymes, proteins and other raw materials for diagnostic and biopharmaceutical production. Always abreast with market developments, we are a key player in enabling a new generation of mRNA therapeutics.

Our guiding tenet is to minimize variation of products built on our raw materials by ensuring best quality, high performance within narrow tolerances, and reliable delivery at the right scale across the globe. Our multitiered approach to quality makes every reagent a building block for secure production and strengthened patient safety.

A core commitment to quality, safety and efficacy - ISO 13485:2016

Our manufacturing processes and product quality controls operate under a Quality Management System (QMS) compliant with ISO 13485:2016. This framework establishes stringent requirements across our entire value chain—encompassing product development, manufacturing, management oversight, and transparency—that are relevant for the specific regulatory demands of the in-vitro diagnostic (IVD) and medical device industries.

Materials management procedures are available, including supplier management
Documents, specifications, and records are controlled
Deviation Management, Corrective and Preventative Actions system, and Change Control procedures
A complaint handling tool and procedure is in place
Activities which may impact product quality are performed by qualified and trained personnel only
Production operations are performed in buildings and facilities suitable for the activities
Measuring equipment is calibrated on set intervals
Raw materials used for manufacturing are traceable
Process equipment is qualified, including computerized systems, and subject to maintenance activities
Storage and distribution activities are subject to written procedures
Each final product batch is subject to release procedures by an independent quality control unit

ISO 13485:2016 certificate for Roche Diagnostics GmbH in Penzberg, Germany

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mRNA reagents with GMP Grade

At CustomBiotech, Good Manufacturing Processes represent more than a baseline for regulatory adherence; they are a commitment to excellence in every phase of production. This approach ensures our operations harmonize the design, monitoring, and control of processes and facilities according to high quality and validation standards.

Validated cleaning procedures are established or single use equipment is used
Analytical quality control methods for release testing are validated
Manufacturing processes, which cannot be subsequently verified, are validated
Procedures are established and maintained for monitoring and control of process parameters for validated processes to ensure that the specific requirements continue to be met

Fit-for-purpose aligns material to its intended use

A final quality tier, our fit-for-purpose requirements for raw materials set and control property tolerances based on the sensitivity of their intended use to those specific attributes. Beyond meeting standards of consistent performance and material purity, our reagents for mRNA synthesis are produced under stringent conditions and undergo additional scrutiny.