High-Quality Chemicals for mRNA Manufacturing
High-quality raw materials and excipients are essential for successful drug manufacturing. Challenges such as enzymatic degradation and instabilities induced by impurities can hinder production efficiency and impact product safety.
Our comprehensive range of high-quality chemical raw materials and excipients, including endonuclease-free chemicals and Emprove® Expert chemicals with specified bioburden and endotoxin limits, is designed to address these critical challenges. Products include key reagents such as dithiothreitol (DTT) and spermidine, buffers, stabilizers, surfactants, bulking agents, cryoprotectants, and synthetic lipids.
Leverage our integrated offering and minimize risk throughout your mRNA manufacturing process, empowering you to focus on innovation and patient outcomes.
What’s in it for you:
- Comprehensive portfolio: From raw materials for plasmid production and in vitro transcription (IVT) to excipients for final formulation, our offering supports every stage of your pDNA and mRNA manufacturing process.
- Endonuclease-free: A broad portfolio of products tested for the absence of RNase and DNase activity to minimize risk of enzymatic degradation.
- Low in bioburden: Our Emprove® Expert portfolio of excipients with specified low endotoxin and microbial levels is particularly well suited to support your risk mitigation efforts in high-risk applications.
- Quality you can trust: Leveraging our global quality systems and the Emprove® Program, we provide extensive documentation and regulatory support, facilitating your risk assessment efforts.
Endonuclease-free chemicals
In mRNA production, maintaining the integrity of nucleic acids is paramount. Naked mRNA is particularly vulnerable to endonuclease degradation. Contaminants that affect mRNA stability, such as RNases, can inadvertently enter the process through raw materials, making it essential to utilize high-purity, RNase- and DNase-free materials.
Our endonuclease-free chemicals are tested for the absence of endonuclease activity, safeguarding against degradation during critical process steps such as in vitro transcription and downstream processing. Choosing these RNase- and DNase-free products enhances mRNA stability and fosters a more robust manufacturing process, ultimately resulting in higher yields and improved therapeutic efficacy.
Critical components for in vitro transcription (IVT)
The transcription of DNA into mRNA requires essential components: polymerases such as T7 RNA polymerase to catalyze the reaction, nucleoside triphosphates (NTPs) as building blocks, and other components in the transcription buffer that enhance reaction efficiency or prevent mRNA degradation. Our high-quality offering dedicated to mRNA manufacturing includes key chemicals used in the IVT step, such as Spermidine Emprove® Expert and Dithiothreitol Emprove® Essential (DTT).
Synthetic lipids for mRNA formulation
Drug delivery systems, such as lipid nanoparticles (LNPs) are essential for delivering mRNA into target cells while protecting it from degradation. Lipids are key excipients for mRNA formulation, with LNPs utilizing various lipid types. Our synthetic lipids offer consistent, high product quality coupled with tailored support and services, optimal performance for your specific needs.
Find out more about our off-the-shelf and custom synthetic lipid offering
Products
Popular Filters
Products
Emprove® Expert Portfolio: Mitigating risks in high-risk applications
For high-risk applications such as parenteral administration, our Emprove® Expert excipient portfolio is particularly well-suited as it features specified low endotoxin and bioburden levels. Together with comprehensive Emprove® dossier documentation, these products support your risk mitigation efforts, expediting your journey to market.
Our Emprove® Program
Ensuring the compliance of your pDNA and mRNA products involves compiling a vast amount of data, which can require significant time and resource investment. Our Emprove® Program helps facilitate and accelerate your risk assessment continuum, as it offers convenient access to reliable information for our products.
Integrated Offering for mRNA Manufacturing
Interested in finding out more about mRNA stability and scaling up mRNA manufacturing? Explore our dedicated page Advanced strategies for manufacturing stable mRNA products.
Curious to learn more about our complete integrated offering for pDNA and mRNA manufacturing? Discover our products and services for mRNA research, development, manufacturing & formulation, and analytical & quality control.
Related Resources
- Brochure: Chemicals for mRNA Drug Manufacturing
Find a comprehensive overview of our raw materials and excipients tailored to mRNA manufacturing.
- Article: Formulation Strategies for mRNA Vaccines and Therapeutics
mRNA technology offers therapeutic versatility; its delivery systems induce protein production for various applications.
- Article: Manufacturing Strategies for mRNA Vaccines and Therapeutics
Explore technologies to scale pDNA production, mRNA production and mRNA purification for RNA-based vaccines and RNA therapeutics.
To continue reading please sign in or create an account.
Don't Have An Account?