The trend towards smaller facilities for small and large molecule
products supports the trend towards an increased use of modular
solutions. With bioreactors of 2,000 l and less, smaller volumes of
vials and syringes for each facility, and the trends towards smaller
volumes, higher potency and continuous processing of small molecule products, the size related barriers for modular implementation
are going away and the increased integration of manufacturing systems make the benefits of modular and off-site implementation even
more obvious. The ability to build manufacturing capacity globally in
12 months at a highly competitive cost makes it possible to quickly
expand into new markets and exploit smaller market niches.
Looking forward, any modern pharmaceutical manufacturing facility will be of a hybrid design, incorporating more or less of modular
systems, in combination with conventional design and construction.
The trend is towards smaller, more flexible and more efficient facilities.
Modularization is going hand-in-hand with increased use of single use
technologies, continuous processing, and lean concepts to allow for
significantly more efficient and flexible manufacturing capabilities. ■
Pär Almhem, et. al: Using Modular Systems in Solid-Dosage
Manufacturing, Pharmaceutical Technology – Solid Dosage and
Excipients, April 2014
Jan Lilja et.al: Modularisation in Biologics Manufacturing, Pharma
Focus Asia, August 2013
Jennifer Markarian: Modular Factory Concept Gains Traction,
Equipment and Processing Report, May 2012
Paul Thomas, Pharma Facilities: Modular Gains Momentum,
PharmaManufacturing.com, January 2013
Levine HL, et al. Single Use Technologies and Modular Construction
Enable Biopharmaceutical Facilities of the Future.
Levine HL, et al. Efficient, flexible facilities for the 21st century.
BioProcess Int. 2012; 10(S11): 20–30.
cepts, while others are embracing the ideas of modular and flexible
facilities and basing future expansions on these concepts.
As more suppliers are offering modular solutions and more operating
companies are considering using them, the range of offerings is constantly increasing. The acceptance is increasing, but still slower than in
many other industries. Reasons for the relatively slow adoption include
the general conservatism of a highly regulated industry, the limited number of brown or green field projects in recent years, and the related focus
on upgrades rather than new build. With an improving economy combined with the trend of building in emerging markets, it is likely that the
number of new facility projects will increase, and that the use of modular
concepts in these projects will be more prevalent than in the past.
1989 - 2014
Combining several modular concepts for biologics manufacturing and aseptic filling
in a conventional building shell.