Facility Design for Vaccine Manufacturing—Regulatory, Business, and Technical Considerations and a Risk‐Based Design Approach

The trade-off between inventories, lead time and capacity: application to vaccine supply chain design

“…In such case, the total recovery time can take several years. This is also in line with the "process equals product" view: variations due to process changes need to be submitted to external authorities (Ekambaram and Shamir (2014)).…”

“…For vaccines, the biological processes (bulk) of the vaccine supply chain are subjected to the "process equals product" view. Ekambaram and Shamir (2014) highlight that the aseptic processing technology used for formulation, filling and packaging of vaccines is not significantly different from other classes of sterile drug products. However, the chemical industry entry in Table 3.6 does not refer to such supply chains, but to petrochemical, liquid oxygen, polystyrene, acetic acid supply chains or is not further specified.…”

“…To ensure control of the vaccine product, the process needs to be strictly controlled in terms of equipment and process parameters. Ekambaram and Shamir (2014), Rader (2008) and Ball et al (2009) mention that this view is often expressed as "process equals product". Therefore it follows that the manufacturing facilities need to ensure that the vaccine is produced in a consistent manner and is free of contamination.…”

“…MacCarthy and Atthirawong (2003) investigate and identify factors affecting international location decisions. Ekambaram and Shamir (2014) emphasize that regulatory authorities assess the reliability of a new vaccine production facility. Such assessment is also subjected to the "process equals product" view.…”

“…For the design of a vaccine supply chain, the integration of the facility location and technology selection is highly recommended. However, this approach lacks the lead time consequences of locating a vaccine manufacturing facility: the adoption of an old or a new production technology at a facility has a large impact on the time for regulatory approval (Ekambaram and Shamir (2014)).…”