Vaccine Manufacturing: Process Development and Expertise
Vaccine Development and Manufacturing Capabilities
Vaccines are among the most cost-effective health interventions against pathogens and other infectious diseases, saving millions of lives annually while improving quality of life for countless others. Growing global demand, however, poses severe challenges for vaccine manufacturers. Each new pathogen or outbreak adds to the variety of vaccine types and manufacturing methods needed, preventing establishment of robust processing templates that could improve overall effectiveness, safety, and affordability.
From a manufacturing perspective, many factors are critical to accelerating vaccine production and meeting performance goals. These include predictable scale-up, optimal upstream productivity, robust impurity removal, maximized downstream recovery, speed to clinic, patient safety, and regulatory compliance. Achieving process improvements can drive success for all of the vaccine development platforms described below, but innovative technologies and a high level of application expertise are required.
VACCINE MANUFACTURING PLATFORMS
Virus-Based Vaccines
The process to manufacture attenuated virus-based vaccines is complex, consists of multiple steps and must maintain the infective potential of the attenuated virus.
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Virus-like Particle (VLP) Vaccines
Manufacturing of VLPs involves cell-based expression of the virus-shell protein. VLPs can be expressed in several heterologous expression systems including mammalian cell culture, baculovirus / insect cell culture system, microbial fermentation and plants.
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Viral Vector Vaccines
While the manufacturing process for vaccine vectors is fairly templated, some challenges may arise, since several different viruses with varying properties can be used.
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Plasmid DNA Vaccines
pDNA manufacturing presents several challenges. Production suffers from low productivity of microbial fermentation. Additionally, the purification process is complicated by the fact that the bacterial lysate is highly viscous and contains contaminants with properties similar to pDNA, leading to low resolution separation.
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mRNA Vaccines
Development and manufacturing of mRNA vaccines is comparatively simple, scalable and extremely rapid. mRNA is produced by in vitro synthesis through an enzymatic process, there is no need to remove cells or host cell proteins, and it allows GMP facilities to switch to a new protein target within a very short period of time.
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Protein Subunit Vaccines
Protein subunit vaccines use purified, recombinant fragments of viral proteins as antigens to stimulate the immune system and create protective immunity. Because viral protein fragments are incapable of causing infection, recombinant protein-based vaccines are considered to be safer than use of live attenuated or inactivated viruses.
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Related Articles
- Cost Modeling Vaccine Manufacturing: Estimate Production Costs for mRNA and other Vaccine ModalitiesA custom-designed cost model is used to explore the economics of vaccine manufacturing across several different modalities including mRNA. The model enables greater process understanding, simulates bottlenecks, and helps to optimize production efficiency.
- Attenuated viral vaccines are created through passage and harvesting from foreign cells or hosts. This technical article describes the manufacturing process of these viral vaccines.
- Influenza vaccines are commonly made using egg-based and cell-based manufacturing strategies. Find step-by-step information on the manufacturing process for each method.
- This technical article breaks down the adenovirus vaccine manufacturing process and provides a case study on developing an accelerated and cost-effective single-use adenoviral vector vaccine.
- This technical article breaks down the steps of upstream and downstream bioprocessing and formulation of virus-like particle vaccines.
- Get a step-by-step overview of the plasmid DNA manufacturing process and the challenges in pDNA downstream purification. Read our free pDNA downstream purification eBook for mRNA, plasmid-based DNA Vaccines, and Viral Vector applications.
- See All (6)
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Highlights
Related Resources
e-Book: Enabling Capabilities & Solutions for all Vaccine Platforms
Brochure: Vaccine Bioprocessing Handbook
Brochure: Enabling Vaccines Production - Solving Challenges Together
Brochure: Flexible Manufacturing of Vaccine
Biopharmaceutical Applications Guide
Strategies for Ensuring Biomanufacturing Resilience for Biologics
Emerging BioTalk Blog
Webinar: Collaboration to develop modular facility proof-of-concept for multi-modal bioprocessing activities
White Paper: Developing an Accelerated and More Cost-Effective Single-Use Adenoviral Vector Vaccine Manufacturing Process
White Paper: How Pandemics and Outbreaks Have Influenced the Adoption of Single-use Vaccine Manufacturing
White Paper: Vaccine Manufacturing - Collaboration Helps to Overcome Vaccine Process Challenges
Collaboration - Featured Announcements
Merck and Baylor College of Medicine Collaborate to Advance a Vaccine Manufacturing Platform to Fight Covid-19
Merck Boosts Commercial Viral Vector and Gene Therapy Manufacturing Capacity
Merck Supports Jenner Institute to Reach First Milestone in Covid-19 Vaccine Manufacturing
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