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mRNA Production services - Let us take care of your GMP mRNA manufacturing needs

At NorthX Biologics, we provide state-of-the-art mRNA development and production services, helping our clients navigate the rapidly evolving landscape of mRNA-based therapeutics. Our range of services encompasses every step of the process from initial development to final aseptic fill/finish, ensuring a consistent, high-quality product, whether for research and development (R&D) or good manufacturing practice (GMP) applications.

Pipette in laboratory

Comprehensive mRNA Development and Production Services at NorthX Biologics

At NorthX Biologics, we provide state-of-the-art mRNA development and production services, helping our clients navigate the rapidly evolving landscape of mRNA-based therapeutics. Our range of services encompasses every step of the process from initial development to final aseptic fill/finish, ensuring a consistent, high-quality product, whether for research and development (R&D) or good manufacturing practice (GMP) applications.

Our mRNA production and development services

With the help of advanced technologies, NorthX Biologics delivers high-quality mRNA that can be used to induce protein expression or gene editing: benefit from custom mRNA synthesis, purification, and characterization for research and clinical applications.

mRNA Process Development

Our team of experts at NorthX Biologics optimizes every stage of the mRNA process development. We strive for maximum yield and purity, ensuring that your mRNA therapeutics are manufactured efficiently and to the highest standards.

In Vitro Transcription (IVT)

NorthX Biologics offers IVT services up to 5L in our standard platform, providing scalability to meet your production needs. Our rigorous process ensures high-quality mRNA products, optimized for downstream applications.

Co-Transcriptional or Enzymatic Capping

We provide co-transcriptional or enzymatic capping services to ensure stability and efficient translation of your mRNA products. This essential modification plays a key role in mRNA stability and protein translation efficiency.

Lipid Nanoparticle (LNP) Formulation

Our team is skilled in LNP formulation, an essential step for the effective delivery of mRNA therapeutics. We design and optimize LNPs to enhance mRNA stability and promote efficient delivery to target cells.

GMP and R&D Grade Production

NorthX Biologics is capable of producing mRNA products suitable for both GMP and R&D applications. Regardless of the scale and purpose of your project, we maintain the highest standards of quality and consistency.

 Aseptic Fill/Finish

We provide aseptic fill/finish services to ensure your mRNA products are appropriately packaged and ready for distribution. Our aseptic processes are designed to maintain the integrity and quality of your product, preparing them for successful clinical use.

Aligned Phase-Appropriate Analytics

At NorthX Biologics, we understand the importance of comprehensive and aligned phase-appropriate analytics. We provide robust analytical services to track the progress of your product throughout its development and production stages, ensuring consistent quality and regulatory compliance.

Choose NorthX Biologics for mRNA Development and Production Services

From initial process development to final fill/finish, NorthX Biologics is your trusted partner for comprehensive mRNA development and production services. Contact us today to discover how our dedicated team can support your mRNA therapeutic project.

As contract service providers, we offer:

  • Process Development;
  • IVT up to 5L in standard platform;
  • Co-transcriptional or enzymatic capping;
  • LNP formulation;
  • GMP and R&D grade;
  • Aseptic Fill/Finish;
  • Aligned phase appropriate analytics;

Learn more about GMP mRNA manufacturing

What is mRNA production?

Messenger RNA, or mRNA, is a type of RNA that carries genetic information from DNA to ribosomes, which are responsible for protein synthesis. The process of mRNA production involves transcription, where DNA is converted into RNA, and translation, where the mRNA sequence is translated into a protein. Understanding the intricacies of mRNA production is essential for developing various therapies, including mRNA vaccines and gene therapies.

NorthX Biologics, a biologics company specializing in GMP compliant mRNA manufacturing, shares their expertise and insights to provide a comprehensive understanding of this complex process.

mRNA production has become a crucial tool in drug development.

mRNA-based vaccines, such as the COVID-19 vaccines, use lipid nanoparticles to deliver mRNA into cells to stimulate an immune response. mRNA therapeutics are also being developed as a new class of drugs that can be used to treat a variety of diseases.

The mRNA is produced using plasmid DNA, which is then transcribed into mRNA and delivered to the cells. This has the potential to revolutionize the field of medicine by allowing for the production of highly specific drugs that can be tailored to individual patients.

What is the mRNA manufacturing process?

mRNA, or messenger RNA, is a type of genetic material that carries instructions from DNA to ribosomes, where proteins are made. In other words, mRNA plays a crucial role in protein synthesis, which is essential for biological processes in our bodies.

To produce mRNA at large scales, NorthX Biologics uses a sophisticated manufacturing process that involves several operations. The process starts with the extraction of raw materials, such as plasmid DNA, from bacterial cultures. The plasmid DNA is then purified and used as a template to synthesize mRNA.

Trust our mRNA development and production capabilities

NorthX Biologics has developed state-of-the-art systems to monitor the manufacturing process and ensure that the final product meets the required specifications. By doing so, the company can guarantee the safety and efficacy of its mRNA products, which are used in various fields, including medicine, agriculture, and biotechnology.

What are factors affecting mRNA production?

Factors that can influence mRNA production include the quality of the starting material, the efficiency of transcription, and the stability of the mRNA product. Here are four key considerations to keep in mind when working with mRNA production:

  1. Quality control is crucial in any mRNA production process. Testing for purity, identity, potency, and sterility are all important steps to ensure the final product is safe and effective.
  2. Lipids play a critical role in mRNA-based vaccines by providing a delivery mechanism to target cells. Choosing the right lipid and optimizing its concentration can greatly enhance the efficacy of the vaccine.
  3. The mRNA manufacturing process involves multiple chemical reactions that must be carefully controlled to ensure optimal yields. Factors such as temperature, pH, and reaction time can all influence the final product.
  4. The purification platform used to isolate the mRNA product can also impact its quality and yield. Choosing the right purification method and optimizing its parameters can help ensure a high-quality and consistent final product.

By considering these factors, you can optimize your mRNA production process to generate high-quality mRNA products that meet your specific needs. Whether you're working on mRNA-based vaccines or other applications, understanding these key considerations can help you achieve your goals with greater efficiency and effectiveness.

What technologies are used by NxBio for their GMP mRNA manufacturing?

mRNA production involves various materials and phases to produce an effective drug substance. By using the latest mRNA technology and adhering to best practices in mRNA manufacturing, biologics companies like NorthX Biologics are able to produce high-quality mRNA constructs that are essential for the development of life-saving treatments and therapies.

  • One of the most common methods is the use of DNA plasmid that contains the mRNA sequence, which is then transcribed into mRNA through a process called in vitro transcription. The mRNA produced is then purified, modified, and formulated into a drug product.
  • Another technology used in mRNA manufacturing is the use of cationic lipids. These are lipids that are positively charged and can encapsulate the mRNA to protect it from degradation. The mRNA-lipid complex, also known as mRNA-LNP drug product, is then delivered through a process called transfection. The cationic lipids also aid in the cellular uptake of the mRNA, allowing it to be translated into a protein.
  • Process testing is also a crucial part of mRNA production. This involves monitoring the entire manufacturing process to ensure the quality and consistency of the mRNA-based vaccines or drug products produced. The mRNA modifications, such as cap and poly(A) tail addition, are also monitored to ensure the stability and efficacy of the mRNA.
With the advancements in technology, mRNA production has become more efficient and reliable, leading to the development of effective mRNA-based vaccines and drug products. 

Glossary about mRNA manufacturing

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