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Bioprocess Filtration

Advance filtration from process development to manufacturing

As bioprocesses scale from development to manufacturing, filtration challenges can arise across the workflow as a result of evolving process conditions, tightening impurity tolerances, and increasing performance expectations. Bioprocess filtration should be evaluated at each stage based on process objectives, upstream conditions, and downstream processing (DSP) requirements.

 

Early stages focus on managing cells, debris, and solids load during harvest and clarification. As processes advance and regulatory scrutiny increases, emphasis shifts to controlling residual impurities and bioburden while maintaining operating consistency and system integration to support scalable manufacturing. At Thermo Fisher Scientific, bioprocess filtration solutions are designed to align with these requirements across process development and production.

The role of filtration across the bioprocessing workflow

During harvest, filtration conditions the feedstream by reducing cells and debris prior to downstream processing. In early downstream stages, it helps manage turbidity and impurity load ahead of chromatography and purification. Closer to final preparation, filtration supports particulate and bioburden control as part of a broader contaminant control strategy.
 

How filtration is configured and staged across these transitions can influence process flexibility, scalability, and risk. Integrating filtration decisions within the broader workflow helps connect early-stage process design with downstream performance and manufacturing readiness.

Enhance processes with bioprocess filtration

Filtration is used effectively when evaluated as part of the broader bioprocessing workflow, where decisions made upstream influence downstream performance. Considering filtration in relation to upstream conditions and downstream requirements helps inform the technology, configuration, staging, and assessment of unit operations during process development and scale-up. We support this evaluation by aligning filtration solutions with overall process design and scale-up planning. 

Harvest and clarification

Apply filtration during harvest and clarification to manage cells, cell debris, and soluble impurities early in the workflow. These steps condition the process stream for downstream operations and help reduce the impact of feedstream variability without adding unnecessary complexity.

Chromatography and purification

Protein purification has significant downstream effects, particularly when moving from lab to production, and can be challenging to scale while intensifying the process and achieving high load capacity. Thermo Fisher brings innovative solutions with AEX polishing chromatography that incorporates both a Q-functionalized non-woven fiber and an innovative guanidinium ligand membrane, which combined provide robust viral clearance and host cell protein reduction.

Operating across a wide range of conditions, the Polisher ST Membrane Adsorber allows you to do more with less. We bring expertise in solutions that help you accelerate your speed to market, while intensifying your downstream processes.

Sterile filtration

Apply sterile membrane filtration during processing or as a final control step prior to fill to remove viable microorganisms and provide microbiological control. Performance, regulatory expectations, and integration into single-use and closed workflows are evaluated alongside fluid management.

Designed for scalability, consistency, and control

As volumes, operating conditions, and process requirements evolve, filtration strategies are refined to maintain scalability, consistency, and control. Evaluate filtration performance, configuration, and integration over time supports the consideration of scale-up requirements and helps maintain control as processes progress across stages and facilities. 

Supporting diverse bioprocessing modalities and applications

Filtration requirements vary by modality, process design, and development stage. Differences in feedstream composition, impurity profiles, and downstream process requirements influence how filtration is evaluated and applied.

Monoclonal antibodies and protein clarification

As demand for monoclonal antibodies (mAbs) continues to grow, teams face increasing pressure to achieve higher productivity, consistent quality, and scalable processes. Filtration is applied across monoclonal antibody and recombinant protein workflows to support harvest, clarification, and downstream conditioning, using technologies, such as Harvest RC Chromatographic Clarifier platform, Zeta Plus depth filters, Emphaze AEX Hybrid Purifier, and Polisher ST Membrane Adsorber, as part of integrated upstream and downstream strategies.

Thermo Fisher offers mAb bioprocessing solutions across the full workflow, incorporating filtration alongside cell culture, centrifugation, chromatography, and process liquid management to help evaluate, optimize, and scale processes in alignment with program requirements.

Gene therapy

Gene therapy workflows present filtration considerations tied to viral vector sensitivity, low product concentration, and scale-dependent variability, where small process changes can significantly influence recovery and purity. Filtration is applied during clarification to address cells, debris, and process-related impurities while preparing streams for downstream purification. Depth filtration, chromatographic clarification where applicable, and membrane-based approaches are integrated with downstream steps and assessed in the context of closed processing and scalability as programs move toward manufacturing.

Vaccine manufacturing workflows

Vaccine development and manufacturing require confident decisions that balance speed, quality, and performance as processes move from process development into commercial-scale production. 

 

During harvest and early clarification, technologies such as the Harvest RC Chromatographic Clarifier platform are applied to help manage cells, debris, and process-related impurities. Zeta Plus depth filter capsules are used across clarification and downstream conditioning to address particulate and impurity burden.

 

These filtration approaches are evaluated alongside broader vaccine bioprocessing solutions to inform decisions as workflows are designed and scaled.

Plasma-derived therapeutics

Plasma fractionation and purification involve complex feedstreams and multiple separation steps that require careful management of particulates and impurities across the process. Zeta Plus depth filters come in sheet, cartridge, and capsule formats. Zeta Plus depth filter capsules can fulfill depth filtration needs in an easy-to-use format.

 

Sterile membrane filtration is applied as part of plasma processing workflows to support microbiological control in highly regulated environments. LifeASSURE PDA filters come with advanced pleat technology to increase the effective filtration area with advanced pleat technology to increase the effective filtration area.

Chemical pharmaceuticals

Chemical pharmaceutical manufacturing involves a wide range of chemistries and processing conditions that influence filtration requirements across multiple stages, including active pharmaceutical ingredient (API) manufacturing and sterile filtration. Membrane-based separations and depth filtration are applied for clarification, impurity reduction, and sterile filtration in alignment with process and regulatory needs.

 

Zeta Plus activated carbon filters and Zeta Plus SP depth filter are used to support clarification and impurity management, while LifeASSURE membrane filters are applied where membrane-based separations and sterile filtration are required. Filtration configurations are selected based on process requirements and facility design.

Process insight to support filtration decisions

Process-focused insight supports evaluation of filtration strategies across process development and manufacturing. We bring application experience, technical knowledge, and educational resources to help teams assess tradeoffs and align filtration choices with evolving process requirements.

Sustainability considerations in bioprocess filtration

Evaluate filtration strategies in the context of sustainability goals alongside process and performance requirements. Approaches, such as process intensification, reduced unit operations, and single-use technologies, are considered for their potential to reduce water, energy, and material use in bioprocessing workflows. By examining how filtration choices affect resource use, waste generation, and process design, teams can better understand how early decisions influence long-term sustainability outcomes.

Discover filtration resources

Explore optional resources designed to support a deeper understanding of bioprocess filtration topics and decision-making considerations. Available materials include technical documents, webinars, and educational content that address practical applications, emerging trends, and process challenges across bioprocessing workflows. 

Explore the School of Purification

Gain practical insights into filtration, purification strategy, technology transfer, and emerging therapeutic applications.

 

Whether you are strengthening foundational knowledge or evaluating approaches for process development and manufacturing, the School of Purification supports ongoing learning across bioprocessing workflows.

Intended use of the products mentioned on this page vary. For specific intended use statements, please refer to the Instructions for Use for the product.