CDMO Spotlight

A Conversation with CATUG

April 2024

Welcome to the April edition of our CDMO Spotlight Series! In this series, we interview CDMOs with the goal of understanding more about their business and their specific differentiation within their sectors.

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It was a pleasure interviewing Sadie Armstrong, Business Consultant at CATUG.  CATUG Biotechnology provides novel CRDMO services focusing on mRNA vaccines, therapeutics, and gene and cell therapy (GCT). Plasmid, mRNA, LNP, Fill and Finish, and analytical QC are their fundamental technology platforms. CATUG aims to provide end-to-end solutions to its clients in the life cycle of mRNA therapeutics and GCT product development. The company customizes unique services and creative solutions to fit each client's needs and timeline.   Hear from them in their own words what sets them apart in this competitive space. 

  1. What are your organization's core capabilities?
    Driven by focus, speed, and flexibility, CATUG Biotechnology has helped over 150 clients reach their milestones since CATUG’s founding in 2021. CATUG will make your mission our own as we help guide your mRNA based therapeutics and gene and cell therapy products through the development journey to final commercialization. Led by our experienced team of over 200 full time employees, our state of the art R&D and GMP facilities are carefully engineered and designed to provide end to end solutions for mRNA therapeutics and gene and cell therapy products under one roof, from R&D to commercial manufacturing. Therefore, no matter which phase of the journey you are in, partnering with CATUG is guaranteed to accelerate your path from development to patient, while ensuring quality, compliance, and efficiency.

    Plasmid DNA R&D and Manufacturing 
    CATUG’s strong knowhow and world-class technology allows your team to customize your DNA construct and successfully screen for host cells. We aim to provide the most optimal pDNA product and manufacturing processes to our customers. 

    RNA Therapeutics R&D and Manufacturing 
    CATUG’s industry leading synthesis techniques also allow for custom mRNA, saRNA, and circRNA synthesis, which can be delivered as fast as 4 weeks. 

    mRNA LNP Drug Product R&D and Manufacturing 
    Determining a lipid nanoparticle (LNP) formulation that will ensure successful delivery of your mRNA can be quite a complex process without efficient screening methods and knowledge of process parameters. Our experts collaborate with your team to provide a customizable LNP formulation suitable for your application. 

    CatPure™ mRNA Catalog 
    If you are aiming to conduct your own internal pre-clinical studies, CATUG also maintains a catalog of high quality research-grade mRNA and mRNA encapsulated LNPs developed using their proprietary CatPure™ mRNA technology. 

    Since 2021, CATUG has rapidly built a client-first organization on expertise, flexibility, and innovation that has solved difficult challenges in the mRNA space for clients such as Moderna, Regeneron, Pfizer, BeiGene, and the Cystic Fibrosis Foundation, to name a few. Undoubtedly, we have outfitted our facilities with the most advanced equipment and qualified staff to ensure the highest quality partnering experience, deliverables, and drug products. By working together, we are confident we can make groundbreaking advancements in mRNA therapeutics, leaving a lasting impact on patients globally. 

  2. What sets your organization apart from its competitors? 
    CATUG incorporates decades of experience, strategic vision, advanced technology platforms, and efficient operations to help you achieve your milestones for your mRNA therapeutics and cell and gene therapy products. Partnering with CATUG will assure you a more straightforward and faster timeline from development to the clinic while also working with leaders in the field who always prioritize your goals and requests. 

    All Under One Roof 
    CATUG is uniquely positioned to provide a comprehensive service to clients focused on mRNA vaccines and therapeutics as well as gene and cell therapy.  

    Commitment to Innovation 
    Innovative and technology-driven, CATUG has established in-house proprietary technologies that enable improved drug product characteristics and manufacturing processes. 

    CATUG 4F1Q 
    CATUG operates under our 4F1Q principle in that we ensure Quality through core values of Focus, First, Flexible, and Fast. 

  3. What can a potential client expect from the onboarding process? 
    Once you have decided CATUG is the best fit for your project, our streamlined and focused onboarding process will build the foundation for our successful collaboration. With our 4F1Q principle at the forefront, a kickoff meeting will allow for both of our teams to introduce themselves, identify key contacts on both sides, and discuss project goals specific to your needs. We will clearly outline deliverables, timelines, and specific requirements, assuring a shared understanding of the project objectives and milestones. To ensure a quick and smooth transition, we will also develop a technology transfer plan that will include information on transferring knowledge, previously used processes, product specifications, and other relevant documentation for your specific case. To ensure the best possible outcome, regulatory requirements, quality assurance, and how we will address mid-project modifications will also be discussed. Finally, we will implement an exit plan in the case that the collaboration needs to be terminated for any reason. 

  4. What is your organization's standard communication protocol? 
    When working with CATUG you are sure to have a clear line of communication with CATUG team members from the very beginning of the partnership. We will use a quality agreement to lay the foundational responsibilities and expectations of both parties during the project. We will schedule regularly occurring meetings to ensure both parties are aligned on project objectives and timelines throughout the project. This time will also be used to distribute project progress reports and openly discuss any issues that may need to be addressed. If any questions arise, our global project management team will be there 24/7 to guarantee a response to your query as quickly as possible.  To provide document confidentiality and protection, CATUG has a comprehensive and secure data management system that safeguards information at every stage of the data life cycle. Moreover, we also utilize good documentation practices (GDP) to ensure accurate and traceable documentation of all activities, including communication records, project plans, etc. 

  5. How do you handle and address mid-project adjustments? 
    As projects move forward, it is inevitable that an adjustment of some variety will occur. CATUG navigates these adjustments with effective communication, flexibility, and speed. We can discuss the proposed adjustments and dissect their impact to the project scope during the regularly scheduled project meetings; however, we also welcome these discussions as soon as they are evident and will schedule additional calls as needed.  A risk assessment between both parties will provide the best way forward so that the project still achieves quality, budget, and timeline objectives. CATUG will also accommodate the changes as needed for each client by reallocating resources, including adjusting equipment usage, workforce, and scheduling. Additionally, we will develop new approaches as needed to deliver custom solutions for the project. Any agreed changes to the project plan will be documented appropriately with clear justification. If adjustments impact any aspects of the regulatory process, CATUG will work with the client to ensure any necessary regulatory submissions or notifications are prepared and submitted. 

Thanks to Sadie for taking the time to talk with us! We hope this has given you a helpful introduction and insight into CATUG Biotechnology and has enhanced your ability to make informed decisions for you and your business. Be sure to check out CATUG SciRank's page and visit their website to learn even more.