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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.

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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
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 Modalities
A 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.
Cell-based Vaccine Manufacturing Processes for Creating Attenuated Viral Vaccines
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.
Egg-based and Cell-based Influenza Vaccine Manufacturing Methods
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.
Adenovirus Vaccine Manufacturing Process
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.
Virus-like Particle (VLP) Vaccine Bioprocessing and Formulation Steps
This technical article breaks down the steps of upstream and downstream bioprocessing and formulation of virus-like particle vaccines.
Plasmid DNA (pDNA) Manufacturing Process: Downstream Purification
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.
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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

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Virus-like Particles (VLPs) Vaccine Manufacturing

VLP vaccine manufacturers must optimize upstream productivity with reliable scale-up, achieve yield and efficiency goals with robust impurity removal, maximize downstream recovery, and ensure patient safety. MilliporeSigma’s integrated portfolio, regulatory and applications expertise can help address these process challenges.

Virus-Based Vaccine Manufacturing

Manufacturing viral vaccines is complex and there is no templated approach. Each process must be tailored to the shape, size, nature, physico-chemical behavior, stability, and host specificity of the virus. Learn all about this core platform technology and how expertise—empowered by collaboration— can overcome manufacturing challenges.

Viral Vector Vaccine Manufacturing

A relatively templated manufacturing process can be used to produce live vector vaccines. Challenges exist, however, and include yield loss due to sterile filtration, vector aggregation and scaling adherent cultures. Learn all about this core platform technology and how expertise—empowered by collaboration— can overcome manufacturing challenges.

Plasmid DNA Vaccines Manufacturing

Manufacturing plasmid DNA (pDNA) vaccines is challenging due to low productivity of fermentation and the large size and negative charge of the plasmid. The lysate can also be highly viscous with contaminants similar to pDNA leading to low resolution separation. Learn all about this core platform technology and how expertise—empowered by collaboration— can overcome manufacturing challenges.

mRNA Vaccine Process Manufacturing

Development and manufacturing of mRNA vaccines is relatively simple, scalable and extremely rapid. A range of technologies are available to increase process productivity, maximize yield, recovery and impurity removal. Learn all about this new platform technology and how expertise—empowered by collaboration—can refine mRNA approaches.

Related Product Categories

Bioprocessing Mobius^® Single-Use Bioreactors

The Mobius^® Bioreactor family includes the bench scale (2 mL and 3 L), pilot, clinical and commercial manufacturing (50 – 2,000 L) single-use bioreactors that enable cell culturing capabilities from early process development through commercial batch production.

Upstream Process Chemicals

Our portfolio of upstream process chemicals provides biopharmaceutical manufacturers with high-quality raw materials for every stage from research to commercial application, backed by supply chain transparency, reliable sourcing, and best-in-class regulatory support.

Virus Inactivation

Our virus inactivation offerings provide biopharma manufacturers with improved options for HTST pasteurization, low pH and chemical/detergent treatment, ensuring virus-free products while simplifying compliance and documentation.

Bioprocessing Liquid Cell Culture Media & Buffers

We offer the industry’s highest quality sterile liquid capabilities, supplying ready-to-use cell culture media, buffers, CIP and SIP products from GMP facilities worldwide to optimize your biopharma production.

Bioprocessing Cell Culture Media

Our off-the-shelf and customizable bioprocessing cell culture media (CCM) products enhance productivity in upstream mAb, vaccine, gene/cell therapy processes.

Clarification Filter Holders and Systems for Bioprocessing

Our flexible hardware and systems for disposable depth filters are ideal for clarification at pilot and process scales, featuring the modular Pod device that enables scale-up and scale-down within the same footprint.

Downstream Process & Formulation Chemicals

Our broad portfolio of downstream chemicals simplifies raw material specification with optimized quality attributes for all your applications – while providing industry-leading support and documentation to help navigate regulatory challenges, manage risks, and improve processes.

Single-Use Mixers

Our complete range of Mobius^® single-use mixing solutions can meet your needs for mixing pharmaceutical ingredients from intermediate to final drug products, as well as preparation of process solutions such as buffers and media.

Collaboration - Featured Announcements

MilliporeSigma and Baylor College of Medicine Collaborate to Advance a Vaccine Manufacturing Platform to Fight Covid-19
MilliporeSigma Boosts Commercial Viral Vector and Gene Therapy Manufacturing Capacity
MilliporeSigma Supports Jenner Institute to Reach First Milestone in Covid-19 Vaccine Manufacturing

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