Looking to take that promising vaccine candidate into production? We can support you through our principals, ThermoFisher Scientific, with products and services aimed at getting you there faster.
Whether it is cell culture media and feeds, buffers, peptones, pharma analytics, purification, or single-use solutions going from cell factory systems to single-use bioreactors, ThermoFisher Scientific has you covered.
Cell culture
From research and process development to large-scale manufacturing, the ThermoFisher Scientific 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
Purification
Thermo Scientific CaptureSelect and POROS resin technologies address purification challenges in the vaccine production workflow. There are a variety of resins on offer 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-tagsystem
- Efficient single-step capturing and polishing of large molecules with POROS Anionand Cation exchange solutions
- Orthogonal purification solutions for hydrophobic molecules with POROSHIC resins
- Affinity platform for the production of viral vectors such as Adeno-Associated Virus (AAV)and Adenovirus (Adv5)
Analytics – contaminant and impurity QC testing
For regulatory approval of the final vaccine product, QC testing must be implemented. ThermoFisher Scientific offers 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. ThermoFisher’s resDNASEQ Quantitative DNA solutions are available for popular expression systems, including HEK293, E. coli, Sf9, CHO, baculovirus, MDCK and Vero cells. Customers working with HEK293 cell lines for vaccine development may want to consider the Applied Biosystems resDNASEQ Quantitative E1A DNA Fragment Length Kit to accurately quantitate residual HEK293 fragments and help ensure the efficiency of downstream process.
Quantitation of residual plasmid DNA from the kanamycin resistance gene in vaccine production
ThermoFisher’s resDNASEQ Quantitative Plasmid DNA solution is available for quantitating all common kanamycin resistance plasmids by targeting multiple allele families.
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.
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.
