MilliporeSigma

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
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.

Graphic of a Virus-Like Particle (VLP)
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.

Graphic of a Virus-Like Particle (VLP)
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.

Graphic of a DNA strand
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.

Graphic of split DNA
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.

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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