The impact vaccines can have on quality of life has fuelled an ever increasing demand for yet more advanced vaccine products, ranging from new agents for treating seasonal flu and cancer, through to products that will avert the threats presented by emerging diseases and bioterrorism.
A full continuum of centrifuge-related products is being offered by Beckman Coulter to aid the development and production of improved vaccines. Beckman Coulter can provide the ideal centrifuge to meet the needs of your laboratory, ranging from preliminary cell clarification through to inactivated viral splitting or purification.
With over 60 years’ experience, Beckman Coulter has a comprehensive centrifugation portfolio that offers high-speed and quality separations. Whether bacterial, viral or cell-based vaccines are the focus of your laboratory, this product range delivers advanced technology, improved yield and the ability to meet challenging development and production targets. In addition, complementary solutions for the vaccine environment are offered by Beckman Coulter such as flow cytometry solutions, automated cell viability analyzers and protein characterization systems. Figure 1 and Figure 2 show the Avanti JXN 26 and the Optima XPN 100 offered by Beckman Coulter.
Figure 1. Avanti JXN 26
Figure 2. Optima XPN 100
Beckman Coulter has adopted a modular approach, which helps address the issue of cross-contamination by providing lot-to-lot comparability. This accelerates the time-to-market, reduces development costs and ensures dose efficacy, all while delivering the long-term commitment and reliability you would expect from Beckman Coulter. With our rotors, tubes, instruments, adapters and bottles all designed to work together as a comprehensive system, Beckman Coulter offers products designed with the consumer in mind as researches want faster speeds, improved control of temperature and vacuum systems, larger capacities and increased ease-of-use, thereby affording researchers great reliability, high throughput and good reproducibility of separations.
Compliance with Standards
The electronic and traceability run records of the Optima XPN and Avanti JXN software support the requirements of GLP/GMP environments and 21 CFR Part 11. A comprehensive list of usage histories, run parameters and rotor cycles can be tracked using the embedded software.
Flexibility and High Productivity
Beckman Coulter offers a comprehensive range of advanced centrifuge and rotor systems, meaning researchers can select the best fit for their vaccine-related needs. Offering an extensive range of centrifuge instruments, tubes, rotors and accessories, the systems offered by Beckman Coulter deliver a high degree of versatility and customization, to ensure all processes are efficient, productive and safe. As a global leader in the field, the centrifuge solutions offered by Beckman Coulter help vaccine facilities across the globe deliver high productivity, compliance and efficiency.
Figure 3. Workflow screen capture from Optima XPN.
The easy-to-use and intuitive instrument software provided by Beckman Coulter enables simple programming of the centrifuge runs that can be carried out in the laboratory or even remotely. The Optima XPN/Avanti JXN software features a touch screen format that operators can use to access large digital displays, a detailed set of help options, printable run reports and user programmed workflows. These software systems are consistent with each other, making it is easy for users to alternate between the two. Also, the system features an ergonomic system design to enhance the comfort, productivity and safety of operators.
Clean Room Suitability
The pharmaceutical-grade sterilizing filter system integrated into Beckman Coulter’s centrifuges means concerns over contamination of the vaccine product environment can be alleviated.
These sterilizing systems are made in a controlled environment where they undergo extensive integrity testing. The filter components meet the biological tests specifications listed in the latest revision of the United States Pharmacopeia (USP) for Class VI-121°C plastics and bacterial retention, in compliance with the requirements of the FDA Guideline Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.
In addition, the system is subjected to cleanliness tests in compliance with Title 21 of the U.S. Code of Federal Regulations (CFR) parts 211.72 and 210.3 (b) (6), oxidizable substances, pH, and pyrogens.
Figure 4. JCF-Z reorienting gradient rotor for high-throughput virus and cell isolation
Widely recognized for delivery excellence, quality and good customer service, Beckman Coulter is the company that biological facilities across the globe turn to for solutions to their centrifugation challenges.
Beckman Coulter’s vaccine technology is manufactured to meet or support the exacting standards required of the biologics environment. The technology is backed by Beckman Coulter's ISO 9001 Certified Field Service Organization, a team of highly trained engineers that offer a service operation with a reputation yet to be matched in the industry. Furthermore, the company offers Installation Qualification and Operational Qualification (IQ/OQ) and our experienced customer service representatives ensure that requests are handled quickly and effectively so that facilities continue to run efficiently.
A Powerful Lineup
As shown in Table 1, Beckman Coulter offers an extensive range of high-performance ultracentrifuges. Highlighted in the table are the four most popular centrifuges for vaccine development and the accompanying rotors that are frequently used in vaccine production. Most of the rotors can be interchanged between the different centrifuges in the series. To enhance the centrifugation of biological material, Beckman Coulter also offers HarvestLine single-use centrifuge bottle liners.
The use of HarvestLine System liners eliminates the need for time consuming manual scraping of harvested solids from labware and also improves safety conditions for the operator. These liners can also be sterilized using gamma irradiation and then frozen, to aid the production process.
Table 1. Beckman Coulter Centrifuges and Accompanying Rotors for Vaccine Production.
Figure 5. Typical workflow for egg-based influenza vaccine manufacturing.
Vaccine Development Workflow and Beckman Coulter
Vaccine development can be classified into egg-based and cell-based. The typical workflow for egg-based influenza vaccine manufacturing is shown in Figure 5.
This upstream process begins with embryonated eggs being obtained from biosecure flocks, which are then inoculated and incubated for a number of days so that the virus can multiply sufficiently. Next, the eggs are candled to make sure no cracks occur. They are then chilled overnight and the next day, they are harvested for allantoic fluid. This fluid is then clarified using the appropriate means of centrifugation, depending on what volumes are required for production. For this workflow step, the Avanti JXN-26 is an ideal complement, providing more than enough speed and ample volume.
Next, the virus is chemically inactivated before being filtered and concentrated. Using zonal centrifugation, the virus is then isolated from other contaminating particles, based on size and shape, in a sucrose solution. Here, the Optima XPN, with its fast speed capability, can be used to ensure proper separation. Detergent is used to recover and split the virus, to solubilize the viral membrane and the virus is clarified again by means of centrifugation so that large contaminants are removed.
At this stage, scientists should take advantage of the Optima XPN. The subunit hemagglutinin and neuraminidase proteins are then isolated, inactivated using a second round of formalin and then ultrapurified and concentrated using filtration.
The majority of egg-based vaccine development protocols require three to five centrifugation steps with varying speeds and volumes, depending on the production demands. The protocol lasts approximately seven days, with additional formulation, validation, quality control and lot release following the purification process.
Beckman Coulter’s centrifuges are suitable for use in both egg- and cell-based vaccine development. Key advantages of cell-based development are the lack of dependence on eggs for worldwide production, increased reproducibility and standardization and a potentially speedier processing time.
The downstream process of cell-based vaccine development is similar to egg-based manufacturing, with rounds of centrifugation, inactivation and filtration being needed. The process begins with culturing small volumes of preserved, frozen cells in an incubator at 37˚C. The culture is scaled up and once a specific cell density is achieved, seed virus is placed in the cell-containing bioreactor, where it infects the cell lines and multiplies. Following this, the virus is harvested and clarified using centrifugation.
Highly advanced instruments are required for cutting-edge researchers to use in vaccine development. As a world leader in novel centrifuge solutions, Beckman Coulter can help your laboratory select the best equipment for generating the most efficient workflow.
- Matthews J T. Egg-Based Production of Influenza Vaccine: 30 Years of Commercial Experience. The Bridge. 17–24: (Fall 2006).
- International Federation of Pharmaceutical Manufacturers & Associations. Cell-Culture Based Vaccine. 2014. http://www.ifpma.org/resources/influenzavaccines/influenza-vaccines/cell-culture-based-vaccine.html
- Dormitzer P R et al. Synthetic Generation of Influenza Viruses for Rapid Response to Pandemics. Sci Transl Med. 5; 185ra68: (2013). doi: 10.1126/scitranslmed.3006368
*BioSafe and BioSafety are terms intended to describe the enhanced biocontainment features of our products.
Beckman Coulter, the stylized logo, Avanti, and Optima are trademarks of Beckman Coulter, Inc. and are registered with the USPTO. HarvestLine is a trademark of Beckman Coulter, Inc. All other trademarks are the property of their respective owners.
About Beckman Coulter
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than a quarter of a million Beckman Coulter instruments operate in laboratories around the world, supplying critical information for improving patient health and reducing the cost of care.
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