Infographic: Accelerate Your Path to IND Submission

A successful IND starts long before purification. While upstream development builds the foundation, downstream processing determines whether your harvest becomes an IND-ready product. Early decisions can reduce risk, minimize rework, and create a process that scales with confidence. This infographic explores five key downstream considerations and practical solutions to help support efficient process development. Viral inactivation Capture chromatography Polish chromatography The world leader in serving science 5 downstream decisions to help accelerate your path to IND Key choices in downstream development that can influence scalability, product quality, and manufacturing readiness. Decision guide Thermo Fisher Scientific Solutions Optimizing column performance 2 Which column format streamlines your downstream workflow? Considerations Consistent performance High reproducibility in packing quality is key for reliable yield and purity. Operational footprint and labor Manually preparing and packing columns takes up critical personnel time. Speed to market Minimizing system setup and lead times accelerate development timelines. Thermo Scientific™ GoPure™ Small-Scale Columns • Simplify early process development • Maintain consistency with matched bead heights • Available in convenient 1 mL and 5 mL formats Thermo Scientific™ MiniChrom Columns • Scale down with confidence • Replicate process-scale performance • Ideal for method development and optimization Thermo Scientific™ GoPure™ Preparative Columns • Streamline downstream purification • Improve efficiency with ready-to-use formats • Easily scale to largervolume applications Prepacked chromatography columns Thermo Fisher Scientific Solutions Screening Tools • Speed up resin selection and process development • Run multiple conditions in parallel Resin Selection Tool • Find the best resin for your application • Streamline workflow decisions Selecting the right resins 1 Which resin and approach can best support your molecule and future manufacturing needs? Protein A vs alternative affinity resins Protein A is a well-established solution for monoclonal antibody capture. Alternative affinity resins can provide selective, single-step capture of advanced antibody formats, recombinant proteins, and viral vectors. Dynamic binding capacity A high dynamic binding capacity offers efficient processing of high-titer feedstocks, increasing productivity. Resin lifetime Maximizing reuse cycles can help reduce long-term costs. Considerations These resins are available as bulk formats for high-performance, large-scale processing, and as prepacked columns for simplified process development and scale-up. Explore single-use AEX polishing alternatives for downstream purification. Thermo Scientific™ MabCaptureC Protein A Resin • Maximize antibody yield with high binding capacity • Achieve consistent results with excellent alkaline stability • Enable efficient, reproducible antibody capture Thermo Scientific™ CaptureSelect™ Affinity Resins • Simplify purification of complex biologics • Recover advanced antibody formats, recombinant proteins, and viral vectors with confidence • Deliver reliable, consistent performance Thermo Scientific™ POROS™ Chromatography Resins • Increase productivity with rapid mass transfer • Achieve higher throughput with high dynamic binding capacity Thermo Fisher Scientific Solutions Building data-driven process understanding Do you have the analytical data required to ensure regulatory compliance for your purification process? 4 Considerations Impurity tracking Controlling process- and product-related impurities is vital to supporting safety and meeting strict regulatory standards. Process characterization Mapping the relationship between process parameters and quality attributes helps establish the reliable operational boundaries needed for a successful scale-up. Comparability readiness A solid foundation of analytical validation and data consistency is critical to proving product sameness when transitioning across manufacturing scales. Analytical HPLC columns • Achieve rapid in-process monitoring • Accelerate data-driven decision making Purity and safety testing solutions • Deliver rapid and highly sensitive molecular testing • Detect impurities and identify contaminants with confidence Analytical services • Leverage comprehensive support • Enable confident assay implementation, instrument validation, and regulatory compliance Thermo Fisher Scientific Solutions Planning for manufacturing readiness 5 Will your process scale when clinical demand arrives? Considerations cGMP chemicals • Secure traceable, regulatory-grade raw materials • Available in scalable volumes Raw material supply Partnering with a global supplier helps support consistency and quality standards to keep production timelines on track. Resin or filter scalability Scalable chromatography resins or AEX membrane adsobers support process consistency from development through cGMP manufacturing, helping minimize process redevelopment. GMP readiness Transitioning smoothly to clinical manufacturing requires fully documented, regulatory-compliant materials. Scalable buffer solutions • Ensure consistent quality with Gibco™ cGMP buffers and process liquids • Available as ready-to-use solutions or concentrates in standard and customized formats Manufacturing support • Support single-use system maintenance, fluid transfer designs, and secure chemical sourcing and storing • Scale operations and protect supply chains For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals. © 2026 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. INFG-15026950 Learn more at thermofisher.com/bioprocessforbiotech Downstream solutions designed to help you scale with your process. Thermo Fisher Scientific Solutions Designing an efficient polishing strategy 3 How can you achieve target quality with minimal process complexity? Considerations Aggregate removal Leverage highly selective resins for strong aggregate removal and high monomer yields. Orthogonal purification Combining complementary chromatography modes helps to ensure comprehensive impurity clearance. Step reduction opportunities Multi-modal resins and functionalized membranes combine steps, streamlining purification. Polishing resins Thermo Scientific™ Poros™ Ion Exchange (IEX) Resins • Maintain high dynamic binding capacity • Deliver superior resolution and high throughput Thermo Scientific™ Hydrophobic Interaction Chromatography (HIC) Resins • Achieve exceptional selectivity for trace impurities • Deliver recovery across different biomolecules with tunable selectivity Mixed-mode chromatography • Reduce impurities in flow-through mode • Achieve high monomer recovery Thermo Scientific™ Polisher ST Membrane Adsorber • Provides single-use AEX polishing with robust impurity removal, enabling process compression and scalable, cost-efficient manufacturing