APR May/June 2023 - 32

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BIOPHARMACEUTICALS
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Table 3. FDA Approved drugs made using continuous
manufacturing, 2015-2021.
Product
Orkambi
Prezista
Verzenio
Symdeko
Daurismo
Tramacet
Trikafta
Dolutegravir
Fluticasone
Duvroq
Xofluza
Figure 7. Risk based manufacturing and how ICH Q9 works with
ICH Q8 and Q10.
Tazverik
Cibinqo
Company
Vertex
Jansen
Eli Lily
Vertex
Pfizer
Janssen
Vertex
GSK
GSK
GSK
Roche
Eisai
Pfizer
Approved
2015
2016
2017
2018
2018
2018
2019
2019
2019
2020
2020
2020
2021
Reference
19
19
19
19
19
19
19
19
19
19
19
19
19
Table 2. Approved biopharmaceutical products produced
by continuous biomanufacturing (annual gross sale totaling
$15B, 2012).
Product
Cerezyme
ReoPro
Gona-F
Remicale
Simulect
Rebif
ReFacto
Kogenate-FS
Campath/Lemtrada
Xigris
Advate
Fabrazyme
Neglazyme
Myozyme
Stelara
Simphoni
VPRIV
Company
Genzyme
Centocor/J&J
Serono
Centocor/J&J
Novartis
Merch-Serono
Wyeth
Bayer
Genzyme
Eli Lilly
Baxter
Genzyme
Biomarin
Genzyme
Centocor/J&J
Centocor/J&J
Shire
Approved
1994
1994, 1997
1997
1998
1998
1998
2000
2000
2001
2001
2003
2003
2005
2006
2009
2009
2012
Reference
18
18, 19
18
18, 19
18, 19
18
18
18
19
18
18
18
18
18
18, 19
18, 19
19
about 30+ biological products ranging from replacement enzymes,
blood coagulation factors, and monoclonal antibodies. Some of these
products generate more than a billion dollars a year with Remicade
from J&J reaching about US$6.8B in sales in 2012.
While
platform technologies
are commonly used fed-batch is
the platform of choice, enhancing productivity and reducing
manufacturing cost prompting companies to consider alternate
manufacturing technologies. Continuous processing offers a number
of advantages over batch and it has been successfully implemented
in other industries. Use of continuous processing in biomanufacturing
32 |
| May/June 2023
Advantages and Disadvantages of
Continuous Biomanufacturing
The multifaceted advantages of continuous biopharmaceutical
manufacturing are summarized in Table 4. A model comparison of
continuous bioprocessing platform with stainless steel and singleuse
batch processes across clinical and commercial scales suggests
that continuous operation can boost the savings afforded by singleuse
technologies.23
The reduction in long-term production costs can
make the pursuit of biosimilars economically more attractive for
drug companies.
In addition to affordability, continuous manufacturing can also
improve the accessibility of drugs.24
Failure in manufacturing quality
can lead to drug shortages,24,25 and continuous manufacturing can
deliver products of consistent quality. The ability to produce (plug
and produce, or plug and play) potentially higher-quality drugs on
demand can circumvent overproduction and delays.26
A comparison of batch versus continuous manufacturing processes is
illustrated in Table 4.
The Drive to Innovation and
Industry Excellence
The past decade has seen a significant shift in the nature of the products
being manufactured and sold by the innovative biopharmaceutical
industry. The global biopharmaceutical portfolio of today reflects
started with culture as discussed and it is feasible to apply it to all
manufacturing unit operations in the future. Many of the issues related
to the implementation of continuous processing have been resolved
due to the recent advances in bioprocess engineering, automation,
and process optimization.
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