Choosing the right CDMO partner impacts your current and future drug development projects. Look for a specialized CDMO that offers flexibility, collaboration and innovation services. GFP mRNA is an mRNA expression reagent that expresses the green fluorescent protein (GFP). It is designed to visualize your cell culture in real-time.
If a sponsor is looking to outsource the manufacturing of a therapeutic, they must choose a CDMO with a strong track record in their area of expertise. A well-established partner can provide the knowledge, equipment, and processes to enable the streamlined development of a new therapy for clinical trials and commercialization. A trusted CDMO like Vernal Biosciences has a robust, complex cGMP API synthesis track record, with an experienced team and state-of-the-art equipment. The partner should be able to provide flexibility and support for a wide range of chemistries and sponsors. Choosing a CDMO with experience with multiple product types will help speed the process of bringing a drug to market. The CDMO must have a deep understanding of regulations for each stage of development and manufacture. A CDMO that can provide a holistic view of the process and anticipate issues will ensure that all requirements are met without having to amend an NDA—an expensive and time-consuming endeavor. The CDMO should be able to offer a holistic approach to the production of mRNA vaccines, emphasizing automation to reduce contamination risk, processing times, and costs. Additionally, a CDMO that can use the same tools for manufacturing and analytical development will help streamline data transfer between partners. This will make it easier for sponsors to manage their supply chains and maintain regulatory compliance when utilizing multiple CDMOs.
In the pre-pandemic era, CDMO relationships were often transactional. When a pharma company needed additional capacity or access to a new technology, they engaged the CDMO under a fee-for-service or project-based contract. However, the pandemic demonstrated that a more strategic partnership model is critical to successfully developing and manufacturing advanced therapeutics such as cell and gene therapy (CGT).
For example, when evaluating a potential partner to help develop and manufacture your allogenic CGT product, it’s important to discover if they can perform GMP cellular banking for your cell population of interest. This is essential for establishing a Master Cell Bank (MCB) and Working Cell Bank (WBC) that will be used throughout the production of your product. Another consideration when choosing a CDMO for your eGFP mRNA production is to find out whether they can perform co-transfection with your mRNA. This is commonly required when using a gene editing tool, such as the Clustered Regularly Interspaced Short Palindromic Repeats-associated Protein 9 (CRISPR-Cas9) system, designer nucleases (transcription activator-like effector nucleases or zinc finger nucleases) or transposons, to modify a cell’s genome. Lastly, it’s also important to determine if your potential CDMO can perform fluorescent detection of your eGFP mRNA reaction. This can be done by spotting a small volume of your eGFP mRNA directly onto a white or black 96 or 384-well plate and evaluating with fluorescent imaging equipment or a fluorescent plate reader (ex/em: 482/512 nm). This will allow you to verify that the mRNA has been correctly processed quickly.
A key quality metric for selecting a CDMO is its commitment to international regulatory standards. Look for a CDMO that is ISO 13485 certified, which indicates that its documented processes meet medical device creation and manufacturing standards established by the International Organization of Standardization (ISO). This certification shows that your CDMO will create high-quality medical devices that meet industry requirements and can stand up to third-party audits. A CDMO specializing in biologics should have experience with multiple types of molecules and therapeutic indications. This extensive experience gives them a strong grasp of the specific challenges in bringing complex molecules to market and how to mitigate them through accelerated development timelines. The best biologics CDMOs also understand and comply with cGMP regulations and other global regulatory guidelines to ensure their clients’ products are compliant and safe.
Additionally, a biologics CDMO should stay at the forefront of technological innovation. Implementing new manufacturing solutions can provide drug developers with the specialized capabilities they need for accelerated development and commercialization. This includes utilizing a flexible process that can scale up and down from clinical production to commercial manufacturing. The best CDMOs will be able to demonstrate this flexibility through an extensive portfolio of successful projects. This scalability is one of the key reasons that drug developers choose to partner with biologics CDMOs.
In addition to providing flexibility, collaboration and innovation, the right CDMO should also have the technology and equipment needed for your drug development project. Look for facilities with class 100 clean room suites, laminar flow hoods, biosafety cabinets and isolators critical to high-quality manufacturing. Moreover, the right CDMO should be able to offer formulation services that optimize the physical and chemical properties of your molecules. Choosing a CDMO with broad service offerings, such as raw material supply, cell banking, plasmid manufacturing, mRNA synthesis through in vitro transcription and lipid nanoparticle encapsulation, is also beneficial. This allows you to work with one partner to handle all aspects of your Rese projects rather than multiple vendors. Furthermore, a CDMO that offers a wide variety of capabilities is often better suited to responding quickly and effectively to unexpected events such as materials shortages and transportation shutdowns. The best CDMOs will have an extensive portfolio of experience with a diverse range of molecule types and regulatory submissions, such as Investigational New Drug (IND) applications, NDAs and Biologic License Applications (BLA). They should also be able to demonstrate a strong track record of successfully meeting accelerated timelines. They should be able to offer flexibility and fit with your company’s culture, leadership style and communication.