Article

Manufacturing certainty from advanced quality mRNA reagents

Roche fit-for-purpose and GMP Grade mRNA 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

An ISO13485-certified Quality Management System (QMS) governs our production and supply of mRNA raw materials. The system dictates requirements across our operations — from product and manufacturing to management and transparency — that are relevant to the in-vitro diagnostic and medical device industry.

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 are established
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 a regular basis
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

View certificate

mRNA reagents with GMP Grade

Building upon our QMS, Good Manufacturing Process (GMP) at CustomBiotech means more than compliance. It means deploying our production in a way that harmonizes the design, monitoring and control of processes and facilities according to the highest quality and validation standards.

Equipment cleaning procedures are validated, or single use is established
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.

Impurity testing

What we do

Extended impurity testing for endotoxin, bioburden, host-cell DNA, host-cell protein, relevant heavy metals

Why we do it

Reduces the risk of inflammation, genetic integration, immunogenicity and toxicity that can impact the safety profile of your product

Animal-origin-free production

What we do

We strive for an animal-free production for our mRNA reagent portfolio. For details please contact us.

Why we do it

Precludes the risk of TSE/BSE and other adventitious viral agents from animal-derived components, improving the safety profile of your product

Antibiotic-free production

What we do

Employ a production process that, from the cell bank to finish, uses no antibiotics

Why we do it

Eliminates the risk of allergic reactions and improves the safety profile of your product

Regulatory disclaimers are listed on the respective product pages.

You might be interested in

...