Home » Development Services » Large Molecule Biologics Development How can our biologics experts help you accelerate development and unleash your discovery’s potential? Comprehensive development and clinical manufacturing biologics solutions Over the past 10 years, global demand for biologics has increased to 42 percent of the total clinical pipeline. The $5 billion high growth in biologics is growing at 8-10 percent and a combination of robust demand and limited capacity is driving the need to invest in expanding capacity. To address the needs of this growing market, Thermo Fisher Scientific is continuously investing in state-of-the-art technology and capacity expansions across our Pharma Services global network.1 In addition to investing in capacity, Thermo Fisher employs a vast network of biologics experts that bring deep scientific expertise and offer you the flexibility and speed needed to ensure the success of your molecule. Our strong reputation in successfully transferring complex molecules and proven track record of scaling up biologics, help ensure the gain of cost and time savings at every stage of the development process. You have access to end-to-end, fully integrated services for both drug substances and drug products, delivered on time and on budget—and a simplified supply chain that accelerates development and keeps you ahead in the rapidly changing and growing world of large molecule biologics. Play Video Need help with your next biologics project? Contact us. » Meeting our customers’ unique molecule needs We understand the challenges and the need for flexibility and speed for meeting important milestones and can provide you with the strategic guidance and flexible solutions that are custom built on comprehensive capabilities and experience. Our team of experts are driven by science and bring expertise along with a proven track record of scaling up biologics, to help ensure you gain cost and time savings at every stage of your drug development process. From preclinical to commercial production, our global network of experts understands the long and complex large molecule journey and are committed to help speed your molecule through early phase trials and prepare you for commercial success, faster. Quick to Clinic™️ solution for first-in-human biologic clinical trials The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic™ program, we can deliver your large molecule drug product for first-in-human studies in as little as 14 months. To help reduce the time it takes to get your discovery to patients who need it, our Quick to Clinic™ for Biologics is made with speed in mind. Process development experience and expertise Applying our deep process development skills to significantly increase the batch yield and reduce processing time for your molecule is what we do. Applying Design of Experiment (DoE) methodology to both upstream and downstream development, we define the CPPs and CQAs that enable robust processes, maximize yields, and optimize throughput. We bring more than 20 years of process development experience, including more than 240 biologic development programs, and we know how to transform your discovery into a drug substance via a sustainable process designed to scale from preclinical development to commercial manufacture. We’ll give you access to fed-batch, perfusion and XD® processes technologies and purification processes leveraging single-use, disposable technologies. We offer: Full process development capabilities for mammalian recombinant proteins including monoclonal antibodies Significant experience with CHO (Chinese hamster ovary) and other commercial cell lines Bioprocessing capability at scales up to 2,000 L, across multiple single-use platforms Fed batch and perfusion cell culture processes Time and cost-saving technologies, including XD™ high density cell culture Proven, reliable cGMP biologics manufacturing Cost modeling to develop biomanufacturing strategies We have: Fast, complete solutions for FIH trials Process development optimization for cost and quality Proven technology transfer experience Scalability to commercial manufacturing Strong regulatory track record With a fully integrated global network of cGMP facilities across Europe, North America, and Australia, and offer the flexibility to adapt to market changes and shifts in your product development strategy. After process development, our award winning Tech Transfer team will move your project to one of our cGMP operations for scale-up and production of your development and commercial materials. We are leaders in manufacturing monoclonal antibodies and other mammalian recombinant proteins using single-use technologies. Our expertise spans multiple commercial cell lines including CHO, also specialize in fed-batch and perfusion cell culture processing up to 2,000 L. Analytical capabilities Our analytical capabilities include rapid identification and characterization of your recombinant protein or antibody, development and implementation of cGMP methodologies and data generation for regulatory submissions. Both development and manufacturing analytical methods are created by the same team to avoid delays and errors created by hand-offs. Our breadth of analytical services and capabilities include: glycan profiling, ELISA assays for product and impurity assessments, gel and capillary based electrophoresis, gel and capillary based isoelectric focusing, residual DNA detection, cell-based bioassays, immunologic and colorimetric assays, chromatography, and mass spectrometry. Work with one partner for both drug substance and drug product manufacturing at the development and commercial scale. Our knowledge of formulation development and bioprocessing ensures that your molecule is “formulation ready” regardless of your current stage. Technology transfer expertise and proven track record Technology transfers, either for a scale-up or a move to another facility, are part of the normal course of business. Even when the transfer is urgent, our team has a proven track record of quick, effective executions to get your project back on track and preserve product supply. In 2017 alone, we completed 185 technology transfers: 44 drug substance, three development and 138 commercial. In all cases, we are driven by your deadlines, flexible in our approach and determined to get it Right-The-First-Time, every time. In late clinical phases, and as part of the establishment of your commercial supply, Thermo Fisher Scientific provides a complete validation package according to regulatory and cGMP guidelines, which includes: BLA/PPQ enabling process characterization and validation activities Validation of analytical methods ICH stability studies Container shipment studies CMC documentation in CTD format Delivering global excellence Our client-focused mindset and global expertise implement a best-in-class integrated offering to position your molecule for greater therapeutic and financial success. Our experience guiding new and emerging clients through each phase of drug development has resulted in saving time and cost. Our integrated network of technical, quality, and customer engagement teams are ready to support your drug development journey. The Pharma Services network has 55+ sites across five continents and employs approximately 3,500 scientists, technicians, and engineers with deep technical expertise all working together to ensure the success of your molecule. We currently offer manufacturing locations in the United States, Europe, and Australia, which provides you with simplified logistics and R&D tax advantages. We offer a broad range of solutions that include: Clinical labeling services Clinical supply optimization Clinical trial packaging and storage Cold chain storage and logistics Distribution and logistics Clinical ancillary management 1 $170M invested in CapEx program from 2018-2023 across our St. Louis, MO and Groningen, NL facilities. Download our biologics overview fact sheet to learn more. 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