Search

  • Order Status
  • Quick Order
  • Promos

Vaccine Bioprocessing Solutions

On this page:

Powering results across vaccine bioprocessing workflows

Vaccine development and manufacturing demand confident decisions that balance speed, quality, and performance. Thermo Fisher Scientific supports these efforts with vaccine bioprocessing solutions that help teams design, test, and scale processes aligned with shared performance goals, reducing risk and enabling predictable outcomes.

 

Enabling consistent vaccine manufacturing

Connect upstream processing (USP) and downstream processing (DSP) to support consistent vaccine manufacturing from early development through commercial manufacturing. By optimizing cell culture strategies, virus harvest, purification, analytics, and process liquids, teams can reduce variability, maintain control, and scale with confidence as demand grows. This integrated approach helps translate early development decisions into robust, manufacturing-ready processes.

Aligning vaccine workflows from development to manufacturing

Cell culture strategies

Select and design cell culture strategies that align with viral vaccine modality, scale, and downstream requirements. Adherent cell culture systems and suspension-based systems should be evaluated based on cell line behavior, virus yield, and process control needs, as these early decisions directly influence productivity, consistency, and compatibility with downstream harvest and purification steps throughout development and manufacturing.

 

Chemically defined, serum-free, and animal origin–free (AOF) media strategies support vaccine workflows by helping reduce variability and maintain process consistency. Scalable media and supplement selection enables both traditional scale-up and scale-out approaches for adherent and suspension cultures. Using Gibco media and Gibco peptones allows teams to align development conditions with commercial manufacturing expectations, enabling reproducible virus production and downstream compatibility as processes mature. These media strategies are supported by workflow-focused development services and technical specialists who help optimize conditions and carry early decisions forward into manufacturing.

Virus harvest and recovery

Approach virus harvest as a controlled transition from upstream production into downstream processing, where recovery efficiency, process containment, and handling consistency directly influence yield and contamination risk. Harvest strategies should align with culture format and scale, with closed-system approaches used where possible to reduce open manipulations and support operational control from upstream production through downstream processing.

 

Closed and scalable harvest solutions, such as Thermo Scientific Harvestainer Bioprocess Container (BPC), are designed to enable consistent virus recovery across development and manufacturing scales. Integrating harvest and clarification strategies, such as depth filtration and centrifugation tailored to adherent and suspension processes, helps minimize cells and process-related debris while protecting downstream unit operations. Designing harvest and recovery workflows early supports scalable execution and helps establish consistent purification performance.

Purification strategies

Address purification challenges by selecting workflows that account for the diversity of vaccine formats, including viral vector-based vaccines, proteins, messenger RNA (mRNA), and virus-like particles (VLPs), with purification approaches tailored to vaccine modality. Multi-step chromatographic strategies help balance yield, impurity clearance, and process efficiency while accommodating differences in molecular size, surface properties, and stability. Access to purification development support and experienced technical specialists helps teams translate purification strategies into robust, scalable processes aligned with manufacturing needs.

 

Affinity-based purification can reduce multiple chromatography steps and increase the overall yield by selective capture of target molecules across vaccine workflows, including proteins, VLPs, viral vector-based vaccines, and mRNA. An affinity tag can be added and recognized by an affinity resin specific to that peptide sequence. 

 

Affinity capture using CaptureSelect technologies can be paired with ion exchange (IEX), hydrophobic interaction chromatography (HIC), and mixed-mode chromatography (MMC) steps to strengthen impurity clearance and overall process robustness. Anion exchange (AEX) and cation exchange (CEX) approaches support capture and polishing by managing charge-based heterogeneity. HIC offers an orthogonal separation mechanism based on differences in hydrophobicity, while mixed-mode chromatography uses multiple interaction mechanisms for challenging separations.

Formulation strategies

Establish formulation strategies that support product stability, consistency, and manufacturability as vaccine processes move toward fill–finish and release. Qualified buffers, excipients, and cGMP-grade materials help control variability during preparation, transfer, and storage. Flexible packaging options, along with ready-to-use or ready-to-hydrate formats, enable alignment with manufacturing and formulation requirements, improving workflow efficiency and supply continuity as vaccine programs progress.

Analytics and quality control

Integrate analytical and quality control strategies across vaccine workflows to support stage-appropriate decision-making, product quality, and regulatory readiness. Molecular testing enables timely, actionable data to monitor impurities and contaminants, assess process performance, and inform lot disposition as vaccine processes scale.

 

Regulatory insights offer recommendations and limits for residual DNA per dose, making accurate quantitation important. The Applied Biosystems resDNASEQ Residual Host Cell DNA Kit supports measurement of residual host cell DNA across common vaccine expression systems, including HEK293, E. coli, Chinese hamster ovary (CHO), Sf9/Sf21 (baculovirus expression systems), MDCK, and Vero cells. For vaccine programs using HEK293 cell lines, the Applied Biosystems resDNASEQ Quantitative E1A DNA Fragment Length Kit enables targeted quantitation of residual HEK293 DNA fragments for downstream process monitoring and documentation. Residual plasmid DNA associated with kanamycin resistance genes can be quantified using the Applied Biosystems resDNASEQ Quantitative Plasmid DNA – Kanamycin Resistance Gene Kit.

 

Vaccine production also requires monitoring for adventitious agents. The Applied Biosystems MycoSEQ Mycoplasma Detection System enables rapid detection of mycoplasma at multiple process stages, including cell lines, cell banks, and harvest media, helping reduce downstream contamination risk compared to traditional culture-based methods. Viral safety testing approaches such as the Applied Biosystems ViralSEQ Quantitative Sf-Rhabdovirus Kit enable quantitation of known contaminants in Sf9 and Sf21 cell systems, supporting viral risk assessment for products manufactured using insect cell platforms.

Supporting scale-up and vaccine manufacturing

Advance vaccine programs into commercial manufacturing by aligning workflows, materials, and analytics early in process design. Global supply continuity, qualified materials, and workflow-focused technical support enable teams to maintain process consistency and manage risk as scale and demand increase.

 

Connect with Thermo Fisher Scientific to discuss how vaccine bioprocessing solutions can support your program as it advances.

Frequently asked questions

Integrated vaccine bioprocessing workflows help reduce scale-up risk by connecting cell culture, virus harvest, downstream purification, analytics, and process liquids into a coordinated process design. This alignment helps teams identify sources of variability earlier, maintain control over critical quality attributes, and carry development decisions forward into manufacturing. Improved visibility across unit operations supports more predictable performance as process volumes and operational complexity increase.

Design scalable viral vaccine processes by aligning cell line selection, culture format, and operating conditions with downstream recovery and purification requirements. Early definition of purification strategies helps manage impurity profiles and supports predictable performance at larger scales. Integrating analytical testing early enables monitoring of quality attributes and process consistency, helping teams anticipate scale-dependent effects and prepare workflows for manufacturing readiness.

Purification strategies influence both vaccine quality and operational efficiency by determining how effectively target molecules are recovered while impurities are minimized. Capture steps affect yield and selectivity, while polishing and orthogonal steps enable impurity clearance and process robustness. Well-designed purification workflows help reduce reprocessing and support consistent quality attributes.

Regulatory readiness is supported by analytical and QC testing strategies that monitor impurities, contaminants, and key quality attributes throughout vaccine workflows. Molecular methods for residual DNA, plasmid DNA, mycoplasma, and viral contaminants offer timely, actionable data compared to traditional assays. Applying these methods at appropriate process stages helps teams assess lot readiness and document process performance.

Standardized process liquids and production chemicals help improve reliability by reducing variability introduced during preparation, transfer, and storage. Ready-to-use buffers, qualified raw materials, and consistent packaging formats enable reproducible execution across unit operations. Aligning material strategies early also simplifies scale-up, reduces operational burden, and supports supply continuity as vaccine processes transition from development into manufacturing.

Explore other bioprocessing applications

Apply the same workflow-based approaches across additional therapeutic modalities where scalability, quality, and operational control are critical. From monoclonal antibodies (mAbs) and mRNA to cell therapy, gene therapy, and antibody-drug conjugates (ADCs), integrated bioprocessing solutions help align upstream, downstream, analytics, and process liquids to advance manufacturing readiness across diverse applications.