Rely on trusted solutions that enable timely vaccine design, development, testing, and production. With proven success in supporting vaccine developers and manufacturers, Thermo Fisher is ready to respond and support customers as they tackle the risks and challenges of vaccine production, including speed to market, improving quality, operational productivity, and reducing total cost of ownership.
Viral vaccine production workflow
Cell culture – from research and process development to large-scale manufacturing
Our peptone supplements chemically defined and serum-free media for virus and vaccine production deliver cell growth and virus production equivalent or superior to serum-supplemented systems while also maximizing consistency and reliability and simplifying downstream purification.
- Reduced-serum, serum-free, and animal origin–free (AOF) media and supplement options in scalable formats
- Gibco peptones, microbial and vaccine media tailored for high-quality vaccine production
- Comprehensive media development services and technical support to optimize your entire vaccine workflow
- Easily scalable for cGMP manufacturing
- Custom production and packaging options of AOF reagents available to convert a process with adherent cells to complete AOF operation
Virus recovery – harvesting virus from cell culture
The Thermo Scientific Harvestainer BPC is a closed system solution for harvesting and separating cell cultures grown on microcarrier beads.
Thermo Scientific CaptureSelect and POROS resin technologies address purification challenges in the vaccine production workflow. We offer a variety of resins for affinity, ion exchange (IEX), and hydrophobic interaction chromatography (HIC) applications.
- Affinity solution for efficient and scalable purification of mRNA
- Affinity solution for the purification of proteins and Virus Like Particles (VLPs) using the C-tag system
- Efficient single-step capturing and polishing of large molecules with POROS Anion and Cation exchange solutions
- Orthogonal purification solutions for hydrophobic molecules with POROS HIC resins
- Affinity platform for the production of viral vectors such as Adeno-Associated Virus (AAV) and Adenovirus (Adv5)
- Experienced field support specialists to help you develop your vaccine purification process
Analytics - contaminant and impurity QC testing
For regulatory approval of the final vaccine product, QC testing must be implemented. We offer rapid molecular methods for contaminant and impurity testing across the vaccine production workflow.
Quantitation of residual host cell DNA testing in vaccine production
Regulatory agencies provide guidance on the maximum acceptable level of DNA per dose of vector. Therefore, rapid and accurate quantification is crucial to vaccine manufacturers. Our resDNASEQ Quantitative DNA solutions are available for popular expression systems, including HEK293, E. coli, Sf9 and baculovirus, CHO, and more. The resDNASEQ Quantitative Systems provide accurate, actionable results in hours, while meeting sensitivity requirements.
Quantitation of residual plasmid DNA from the kanamycin resistance gene in vaccine production
Our resDNASEQ Quantitative Plasmid DNA solution is available for quantitating all common kanamycin resistance plasmids by targeting multiple allele families. Get reproducible, rapid and accurate quantification, while meeting sensitivity requirements set by regulatory agencies.
Mycoplasma detection testing in vaccine production
Per regulatory requirements, vaccine therapies must be free of mycoplasma. Manufacturers have traditionally outsourced testing to labs that specialize in the 28-day culture-based test method. Real-time PCR–based assays provide a viable alternative to the culture-based method and provide results in hours while meeting the required sensitivity. The MycoSEQ Mycoplasma Detection System integrates real-time PCR assays, instruments, and software with optimized sample preparation—delivering results in hours, not days. This enables you to test at multiple points in cell lines, cell banks, and harvest media, increasing your productivity and reducing risk of downstream contamination.
Sf-rhabdovirus quantitation in vaccine production
Regulatory agencies expect all biologics to undergo viral testing to reduce the risk of viral contamination. it is important to have an accurate method for quantitating Sf-rhabdovirus which is a known infectious contaminant commonly found in Sf9/Sf21 cells used in gene therapy and vaccine. Get the reproducible accuracy you need when testing for Sf-rhabdovirus from a kit that is part of a total workflow solution designed to lessen your bioproduction testing challenges.
cGMP Production Chemicals and Custom Packaging Services
Expedited scale-up and scale-out is possible with a selection of the broadest portfolio of cGMP production chemicals, across nearly every chemical class and category.
Outsourcing process liquid and buffer manufacturing through Production Chemical Custom Packaging Services allow customers to select the brand of chemicals, any container type and any weight or formulation to receive ready-to-hydrate (dry powders) or ready-to-use (liquids) that optimize workflow efficiencies and reduce total cost of ownership.
|Cell Culture||Virus Harvest||Purification||Formulation||Analytics|
|Catalog chemicals–custom chemical packaging services–supply chain services|
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