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Single-Use mAb Development and Production
Creating a comprehensive and scalable mAb program is a difficult challenge, with many molecules failing to meet the rigorous safety and efficacy benchmarks necessary to reach the commercialization stage. Given this context, building workflows that offer consistency, scalability, flexibility, and high performance can help prepare for success and limit the time it takes to bring a successful drug candidate to market. Whether you are in a development or production cycle, our team of scientific specialists has a proven track record of process support acting as a dedicated partner to meet your needs.
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Explore each stage of mAb development and production:
Process development
The early stages of mAb development focus on gathering scientific evidence supporting the safety and efficacy of the molecule of interest. Finding ways to generate a robust molecular profile early on can help increase efficiencies in later phases of development. With small-scale platforms optimized for high performance, our single-use bench scale solutions offer consistency and reliability supported by a team of experts well-versed in planning for movement into future clinical stages.
Ideal bench scale solutions for process development
The Thermo Scientific GXCore Bioprocess Controller and TruBio Software system is built for bench-scale operations, and provides a compact, cost-effective controller solution to your mAb development process that will grow with you during scale-up.
Consistent automation and control
Increase development optimization and streamline tech transfer with consistency in bioprocess control and automation platforms, created with simplified solutions for PD and with cGMP compliance in mind.
Virtual 3D workflow tour
Explore each unit operation in the mAb process playbook virtual tour to learn how single-use standard and modular single-use manifolds can increase efficiencies in later phases of development.
3D Product Tour: Benchtop Bioprocessing Solutions
Thermo Scientific bioprocess equipment, automation, and control systems are designed to optimize your process from the laboratory bench to full cGMP manufacturing. Our innovative platform combines a flexible operating system with scalable, modular hardware for strategic and streamlined bioprocess control.
Clinical phases
Clinical phases of molecular development require automated platforms with the ability to scale up while maintaining quality control monitoring consistency. These platforms can help ensure that comprehensive data capture and tracking can help support tech transfer efficiencies and process optimization. With supply chain reliability from a trusted supplier, our single-use solutions help mitigate supply chain risks to protect the continuity of your processes.
Sized right single-use bioreactors to optimize yields
The Thermo Scientific DynaDrive Single-Use Bioreactor (S.U.B.) streamlines seed-train process and offers optimized turndown ratio for improved volumetric flexibility regardless of scale.
Build a personalized mAb process with standard single-use designs
Leverage our mAb Process Playbook to implement efficiency savings across the workflow while improving process flexibility from small to large scale operations.
Nalgene platinum certified clean bottles and carboys
Choose the level of clean required for your application to enable quality and regulatory compliance.
Thinking beyond sterility—a tiered approach
Approximately 90% of industry experts surveyed are concerned about particulates, yet only 41% are familiar with USP <788>. Read this e-Book to gain a better understanding of clean parameters, the value of vendor relationships, and how to identify the right level of clean for your mAb manufacturing.
Commercial manufacturing
Your successful commercial manufacturing demands consistent product availability, quality, and performance. We offer both consumable availability and service maintenance support programs to help alleviate any unforeseen downtime in operations. Our industry leading products support optimum productivity in both upstream and downstream bioprocessing and are backed by service support programs to help keep your processes running seamlessly.
Global single-use manufacturing network
Elevate your supply chain resiliency with a globally harmonized manufacturing network to enhance your productivity and assist in decreasing the time it takes to bring products to market.
Production scale bioprocessing equipment
Our industry-leading bioprocess equipment and single-use consumables help provide improved process efficiency, minimized operational complexity, and optimize liquid handling within production-scale manufacturing.
Labtainer Pro BioProcess Container (BPC) with BioTitan Retention Device
Designed with improved handling for better ergonomics and to help eliminate the risk of leaks and failures at the connection point
Protect your process against downtime with Thermo Scientific Bioprocess Integrated Services
Thermo Fisher Scientific is a trusted partner for your automation and single-use bioprocess equipment needs. We understand the importance of maximizing your operational efficiencies and minimizing downtime throughout your manufacturing processes. As a way of protecting your equipment performance throughout its lifecycle, we offer our Thermo Scientific Bioprocess Integrated Services.