Vaccine development and manufacturing

Viral vaccine production

Manufacturing approaches for novel vaccines to address rapid viral responses can include vaccines that are bacterial, virus, protein polysaccharide or DNA-based. Each process requires cell culture, purification, fill and finish, and analysis, though each vaccine has specific workflows. The challenges are similar for all: speed, efficacy, process economy, and risk management. Solutions and resources are provided below to help you solve these challenges.

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Product development support

Resolve specific biomanufacturing challenges and grasp opportunities for upstream and downstream process improvements at every stage of development. Our Fast Trak team of industry-trained experts combine their applications knowledge to solve challenges and optimize your bioprocess. We work with complete transparency and empower you to solve challenges too. Tap into industrial knowledge gained all over the world.

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Topic	Resource	Description
Product development	Article: Accelerated manufacturing of subunit vaccines for a rapid pandemic response	To support the United States government mission to protect the United States and its military personnel by quickly responding to novel threats, scientists from Cytiva's Fast Trak Services and a team of partners worked with the US Department of Defense to develop a platform for rapid manufacturing of critical protein-based therapeutics that are essential for the military.
Product development	Article: Utilizing external collaboration to accelerate vaccine development	One of the most consistent demands for any project is development speed. Janssen Biotherapeutics Development successfully utilized an external collaboration approach to accelerate the process development and production of an HIV vaccine booster. This was essential to reduce both risk and the time needed for delivery of clinical supplies.
Product development	Application note: Accelerate flavivirus vaccine production with modern bioprocess tools and solutions	For a more efficient response to market needs, cell-based vaccine production has become an industry necessity. Technological challenges can dominate vaccine production. An overview of modern products and services that can help solve many challenges is discussed.

Manufacturing and purification

Bringing a vaccine to market isn’t easy. There is a large diversity of vaccines to consider, from viruses and bacteria, to polysaccharides and proteins, with a resulting downside: there is no standard platform. Innovators and manufactures can leverage technologies and support from single-use manufacturers to gain an edge in this rapidly changing field.

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One cGMP operator sampling large scale bioreactor

Topic	Resource	Description
Upstream processing	Application note: Adenovirus production in single-use ReadyToProcess WAVE 25 bioreactor system	Robust production of adenovirus demonstrated in HEK293 suspension cells grown in CDM4HEK293 medium using the ReadyToProcess WAVE 25 bioreactor system. Similar cell growth and productivity was achieved in three bioreactor runs, indicating process robustness.
Upstream processing	Application note: Adenovirus production in single-use Xcellerex XDR-10 bioreactor system	Production of adenovirus demonstrated in HEK293 cells cultured in HyClone CDM4HEK293 culture medium. Scale-up production of adenovirus in single-use XDR-10 bioreactors is shown to have culture performance comparable to shake flasks, indicating a robust and scalable adenovirus production process.
Upstream processing	Application note: Evaluation of HEK293 cell growth and adenovirus productivity in HyClone CDM4HEK293 medium	Growth and adenovirus productivity demonstrated in HEK293 cells grown in shake flasks in CDM4HEK293 medium or in a reference medium. The results show improved cell growth and infectious virus productivity in CDM4HEK293 medium as compared with the reference medium. Scalability of the CDM4HEK293 cultures was demonstrated with cultures grown in an XDR-10 bioreactor system. The results show similar performance between the culture systems, confirming the suitability of using CDM4HEK293 as a platform medium for HEK293 cell culture applications.
Process	Webinar: Optimizing the workflow for therapeutic viral vectors – upstream and downstream	On-demand webinar with industry leaders which discusses key challenges with viral vector production and identifies major bottleneck steps.
Process	Video series: Viral vectors	In this tutorial series on viral vector production, insights on virus production and how to scale up and tackle viral vector manufacturing challenges are shared.
Process	Article: Manufacturing of viral vectors	Robust and cost-effective scale up of viral vector processes is key. This case study is based on adenovirus and the results show a cost-efficient production at all investigated scales and scenarios, making it feasible for industrial production of adenovirus.
Downstream processing	Application note: Downstream scale-up purification of influenza virus using single-use bioprocessing equipment	Purification of influenza virus using single-use bioprocessing technology is described. Total process time for the downstream purification was 3 days and the overall scale-up process resulted in production of influenza virus with the same yield and purity as obtained in the laboratory scale.
Downstream processing	Article: Production of cell-based influenza vaccine	A case study which shows that single-use equipment can replace traditional equipment, including stainless steel bioreactors, user-packed chromatography columns, and ultracentrifuges, for the production of vaccines with high purity.

Bioanalytics

In order to bring vaccines to market faster, industry is adopting new development methods, as well as improved and more flexible manufacturing principles, to increase production efficiency while assuring vaccine safety and efficacy. Biacore systems are used throughout the development process, providing a detailed understanding of a vaccine’s properties and characteristics including:

Vaccine design and characterization
Immune response studies
Analyses during the vaccine production process and QC

Biacore 8K and Biacore Insight Evaluation Software

Topic	Resource	Description
Bioanalytics	White paper: Biacore systems in vaccine development and production	Biacore assays are successfully employed to design vaccines and adjuvants with desired properties, to speed up optimization of process parameters, and to perform batch release tests with great accuracy and precision.
Bioanalytics	Application note: Determination of adenovirus concentration using Biacore T200	Infectious virus particle titer is traditionally determined by various cell based assays (e.g., TCID50) that can require more than a week until results. Two SPR based methods for adenovirus concentration determination are described using the Biacore T200 system, providing robust and reproducible results that correlate with estabilished methods, but with less assay and sample prep time.
Bioanalytics	Application note: Biacore biosensor assays for quantitation of influenza virus and HCP	The need for shorter development cycles has also increased the demand for improved analytical tools in vaccine production. Novel methods for quantitation of influenza virus and HCP using biosensor technology are described.
Bioanalytics	Video: Early-stage SPR assays for recombinant subunit vaccine discovery and process development	Sumana Chandramouli (GSK Vaccines) describes how SPR analysis using a panel of monoclonal antibodies that target key epitopes is used to give a comprehensive characterization of the most sensitive sites and properties of antigens. This allows critical quality attributes to be defined as candidates progress from the discovery phase into later stage development.
Bioanalytics	Video: SPR in early discovery and development of vaccine antigens	The need for novel and more complex vaccines puts increasing demands on the discovery, development and manufacturing pipelines. Markus Sack (Pro-SPR) describes a variety of SPR assays to tackle the development of a multi component malaria vaccine, including characterization of pathogen-specific antibodies from semi-immune volunteers in endemic regions and assessment of their immunogenicity.

Strategies for rapid capacity

The gap in manufacturing capacity for viral vectors is growing. To address this increasing demand, rapid and flexible manufacturing technologies are essential to ensure these novel therapies are reaching patients. Viable solutions include single-use technologies, modular biomanufacturing facilities, and standardized production environments.

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Topic	Resource	Description
Scale-up and capacity	Article: Strategies to address the viral vector manufacturing shortage	The costs and complexities of manufacturing viral vectors, as well as the expertise it requires, have ultimately led to significant gaps in capacity to meet current demand. Options for modular manufacturing and single-use technologies that offer rapid scalable platforms are discussed.
Scale-up and capacity	Article: Evaluating the economics of today’s biomanufacturing strategies: Can you afford the cost of failure?	The decision to manufacture in-house or outsource production is unique to each business strategy. Weighing timelines, intellectual protection, and manufacturing staff capabilities along with standard OpEx and CapEx analysis is key to understanding the best path forward. We assessed one case study and offer an economic model to provide insights into essential elements of your analysis.
Scale-up and capacity	Webinar: A pragmatic approach to the buy vs. build manufacturing dilemma	A case study with ArmaGen discussing the buy vs. build financial model. Gain an appreciation of the critical elements in their business model.
Scale-up and capacity	Application note: Process economic simulation for scalable production of adenovirus	In this process economic simulation, the novel adenovirus production process is compared with a reference process, differing in choice of resins for the virus capture and polishing steps. In addition, single-use and stainless-steel process configurations were compared.

Expertise and support

Count on us for extensive experience and expertise, not only when unexpected issues emerge, but from design stage through launch. Our team will help you optimize components, identify the best-suited technologies, and offer invaluable assistance to help get you in-market earlier. Please contact us with any questions that you may have, whether product, service, or support related.