Session: 02-08-02: Innovative Product and Process Design II

Paper Number: 70516

Start Time: Thursday, 04:30 PM

70516 - Towards Smart Vaccine Manufacturing: A Preliminary Study During Covid-19 

The global outbreak of the COVID-19 pandemic has triggered rapid advancements in the field of biotechnology, especially in vaccine manufacturing. This sector is undergoing tremendous transformation and significant investments have been made to develop vaccines at lightning speed. The pharmaceutical industry has now shifted its efforts from the traditional vaccine development techniques using attenuated or inactivated viruses to novel platform technologies for vaccine manufacturing. Vaccines developed using the platform technologies are based on recent advances in molecular biology and genomics. This remarkable platform approach can also be easily extended, restructured, and redesigned to develop future vaccines to treat a wide range of contagious diseases.

It is instructive to compare this new vaccine product development and manufacturing paradigm with the traditional product design and development approaches. In their well-known study, Ulrich and Eppinger [1]  identify eight types of products based on how the underlying generic product development process has been adapted. According to the World Health Organization (WHO) estimates, there are hundreds of vaccines under various phases of development and clinical deployment, and these vaccines are classified under the relatively new vaccine platforms such as mRNA, Viral Vector, and Protein Subunit. The new classification scheme for vaccines under these platforms seem to overlap many of the product categories of the product classification by Ulrich and Eppinger. Moreover, the vaccine products involve particles at microscopic scale, which create challenges with respect to the product specification and measurement and identifying the observables in the control of vaccine manufacturing processes.

The aim of this preliminary study is to trace the transition of vaccine manufacturing from the traditional methods to the modern platform-based methods to clearly identify and highlight the benefits of vaccine platforms. Furthermore, this preliminary study tries to find a parallel between the traditional product platforming approach and the vaccine platforming approach which might help in the development of global standards for vaccine platform(s) to enhance vaccine production and testing. The paper also explores how the traditional product classification compares with the new classification of the vaccines and develops new insights that might be helpful for the future development and manufacturing of biomedical and bio-industrial products. Finally, a case study is discussed to compare the manufacturing and distribution of Pfizer/BioNtech and Moderna COVID-19 vaccines and to identify key takeaways and challenges. Several avenues for future research are thus identified. This lays the foundation for applying smart manufacturing techniques for vaccine manufacturing to meet the growing needs of the public.

 

[1] Eppinger, S. D., Ulrich, K. T. (2016). Product Design and Development. Sixth Edition, McGraw-Hill, New York

Presenting Author: Vishnu Kumar The Pennsylvania State University

Authors:

Vishnu Kumar Pennsylvania State University
Vijay Srinivasan National Institute of Standards and Technology
Soundar Kumara Pennsylvania State University