Manufacturing certainty from advanced quality GMP Grade mRNA reagents
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
- 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
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
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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.