The Importance of Making Clean and Safe Vaccines
Pharmaceutical companies mass producing vaccines to help the fight against COVID-19 will culture, produce, formulate and transport the vaccine under stringent regulations and guidelines. One for which is the Good Manufacturing Process (GMP) and current Good Manufacturing Process (cGMP) a set of guidelines created and enforced by the Food and Drug Administration (FDA) ensuring products like vaccines are safe, pure and of the highest quality. “cGMP’s provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities”1. Making vaccines is a technically difficult and highly regulated process to ensure safety. For the COVID-19 (SARS CoV2) specifically, the biopharma industry is using an innovative technology that has been in use for the past 20-25 years and it is essential for the COVID-19 vaccine to be reproducible and effective. Pharmaceutical manufacturers have plans to make anywhere from 1 to 2.5 billion doses of COVID-19 vaccine in 2021 and up to 3 billion doses in 20222. Some of the larger pharmaceutical manufacturers have claimed that it takes 6 to 7 months to make the vaccine. The process, design and planning for developing a vaccine requires more people and program management to support operations to enable quick production.
The vaccine manufacturing process (based on multiple pharmaceutical manufacturing sites) and the Personal Protective Equipment (PPE) necessary at each stage is outlined below. A vaccine is produced to protect the people who receive it so it’s imperative that the whole manufacturing process is clean and stringently controlled, one of the biggest risks of contamination is from pharmaceutical personnel, it’s also important that pharmaceutical personnel are protected from hazardous chemicals and biological substances which may be harmful to their health so for their safety and for the safety of the vaccine it’s essential the right PPE is worn, including;
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Disposable Gloves |
Solid front |
Scrub suits, or coveralls with sleeves that fully cover the forearms |
Head coverings |
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Shoe covers |
Eye protection |
Risk assessment should inform the use of respiratory protection (fit-tested particulate respirator, e.g. EU FFP2, US 6 NIOSH-certified N95 or equivalent, or higher protection) |
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Each stage of the vaccine manufacturing process has a designated biosafety level and requires different levels of PPE. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from the various risk groups.3,4
Biosafety Level 1 |
Biosafety Level 2 |
Biosafety Level 3 |
Biosafety Level 4 |
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Basic |
Basic |
Containment |
Maximum Containment |
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Stage in Manufacturing |
Process Description |
Biosafety Level |
Typical PPE |
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Culturing5 |
No longer egg-based. Using mammalian cells in-vitro cultures, culturing to develop antigens using raw material. DNA plasmid production so there is a library of the genetic instructions. |
BS-3 |
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Production |
Bioreactors - mRNA produced from the DNA template using enzymes in a bioreactor.
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BS-4 |
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Formulation |
Producing the lipids needed and combining the mRNA with those to create lipid nanoparticles. |
BS-4 |
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Purification and Freeze Drying |
Removes impurities and concentrates the active ingredient- combine the LNPs with the other components of the formulation (phosphate buffers, saline, sucrose and such) and fill those into vials. |
BS-3 |
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Quality Control |
Automated visual inspection of liquid and freeze-dried vaccine vials and syringe purity followed by fill and leak inspections of packaging for batch release. Around 500 items per minute are inspected for container closure integrity as part of the final inspection (Mirasol, 2020). |
BS-3 |
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Cold Chain Transport |
-80 to -60°C (Pfizer-BioNTech) and -25 to -15°C (Moderna) |
N/A |
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Ansell offers a wide range of solutions that comply with the World Health Organizations guidance regarding infection prevention and control. The primary focus for protection shifts to the product to ensure there is no risk of contamination during the manufacturing process, with facilities either operating in clean or aseptic/sterile environments using PPE with validated sterility levels, cleanliness levels and chemical permeation levels. Identify hazards and reduce workplace injuries with a no-cost AnsellGUARDIAN® assessment.
1. FDA, 2020
2. WHO, 2021
3. www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/
4. Risk Group 1 (no or low individual and community risk) A microorganism that is unlikely to cause human or animal disease
5. Risk Group 2 (moderate individual risk, low community risk) A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.
6. Risk Group 3 (high individual risk, low community risk) A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.
7. Risk Group 4 (high individual and community risk) A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.
8. CDC guidelines specify for virus isolation in cell culture and initial characterization of viral agents recovered in cultures of COVID-19 specimens should
only be conducted in a Biosafety Level 3 (BSL-3) laboratory using BSL03 practices.