5 Considerations When Choosing a Raw Material Supplier for Your mRNA Program
Scientist
on
June 13, 2024
This blog post was written by TriLink BioTechnologies®, a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services and high-quality readymade and custom materials, including its patented CleanCap® mRNA capping technology. Their services are available on the Scientist.com marketplace.
With a multitude of companies promoting their products or services to support the fast-growing mRNA industry, how do you choose a raw material supplier to ensure you have an efficient and problem-free experience? Consider these 5 points during your search to help you make a decision you will feel confident about.
1. Experience & expertise
Expertise often comes in the form of experience. While newer suppliers may provide quality products, they may be limited in the sourcing capabilities and basic experience in the technical aspects of mRNA therapeutic development. Additionally, while mRNA-based research is not new, the COVID-19 pandemic ignited interest in this modality, driving new suppliers into the marketplace.
Questions to consider:
1. What is their experience in mRNA development and optimization?
2. Does the company have a proven track record of delivering raw materials used for clinical and commercial manufacture of mRNA?
2. Quality
It’s important to remember - just because two companies appear to sell the same product, materials can vary greatly based on manufacturing process, country of origin and sourcing and in-house quality standards. In the case of the development of vaccines and therapies, it is crucial to understand specific requirements of your application – the specific regulatory requirements and standards for your current development phase as well as future ones.
Questions to consider:
1. Does your supplier have a transparent quality policy?
2. Are they ISO 9001 (or higher) certified?
3. What is the quality documentation package provided for raw materials used for clinical and commercial mRNA manufacturing?
3. Secondary services
In today’s fast-moving environment of mRNA-based therapeutics and vaccines, finding a partner offering more than just products is ideal to helping you reach your next milestone and ultimately impact patients’ lives. In addition, suppliers offering customizable manufacturing services, including plasmid production, analytical services, fill volumes and container closure configuration may help to simplify and de-risk your supply chain.
Questions to consider:
1. Are you getting the quality data package for your specific phase of development?
2. Does the supplier offer customizable release testing?
4. Inventory & capacity
The capacity of a supplier is an important factor to consider. It is important to be transparent about your volume needs as early as possible. Most life science suppliers understand quantities will ebb and flow during the development process. However, keeping your supplier informed of changes, especially if projects are accelerated to the next development stage, will make sure you have product when you need it.
Questions to consider:
1. What is their ability to provide you with what you need when you need it?
2. Is the supplier able to produce enough to meet your demand?
3. Can the supplier provide phase- appropriate quality of raw materials at the scale needed for each development stage?
5. Communication
How a supplier communicates with customers is a key consideration, specifically for those in buyer roles. During your vendor selection process ask about their order placement processes.
Questions to consider:
1. Will your account be handled by a sales representative or a dedicated program manager?
2. What cadence and mechanisms are used for communication?
3. If I need technical support, will I be able to meet with technical experts?
About TriLink BioTechnologies
Combining expertise in biology and chemistry, TriLink BioTechnologies® is your ideal partner for nucleic acid products and services.
TriLink has revolutionized mRNA capping strategies with its one-pot solution CleanCap® capping solutions which generates the optimal Cap1 structure with more than 95% efficiency. Available in both RUO and GMP-grades, this co-transcriptional capping process helps to shorten therapeutic mRNA manufacturing processes by nearly a week and has demonstrated a reduction in overall manufacturing costs 20-40% lower than other capping methods, allowing you to meet product development deadlines and cost saving targets.
For more than 25 years, TriLink has been a trusted partner of research institutions, pharma, biotech and diagnostic companies. With our comprehensive nucleic acid product portfolio, we can support you from research and discovery to clinical and commercial phases. TriLink operates an ISO 9001:2015 facility, ensuring your mRNA production materials meet reported requirements for identity, purity and safety. Our stringent quality systems and dedicated team of experts ensure consistency in the product, process and documentation.
With a wide selection of modified nucleoside triphosphates (NTPs), we are able to meet most of your application and development needs. Additionally, we were one of the first to market with a GMP-grade N1-Methylspeudouridine and cap analogs to support your programs as they scale into late-stage developmental phases.