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.
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.
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.
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 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.
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
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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