Technologies such as ASI's single-use heat exchanger
(above), EMD Millipore's Mobius platform (above
right) and filtration modules (right) are changing the
way biopharmaceuticals are processed.
itoring and assurance of quality by monitoring Critical Quality Attributes (CQA)
and Critical Process Parameters (CPP) to
facilitate Real Time Release Testing (RTRT).
The new paradigm tools for monitoring and controlling business functions include MRP-II (Materials
Resource Planning), LIMS (Laboratory Information
Management Systems), and EBR (Electronic
Batch Records) integrated systems. Positional
control systems are also being used to control the movement of material, people, and
equipment throughout the facility at all times for all
operational and transition functions. Collectively, these systems provide
comprehensive infrastructure element support in the form of an advanced
MES (Manufacturing Execution System) which provides tools for assuring
continuous control over all aspects of the manufacturing enterprise.
FACILITY AT TRIBUTES
The key attributes of new biomanufacturing facilities are easy to
define yet difficult to integrate. Companies want facilities that are flexible, adaptable to changes in the product mix as well as the process,
efficient in their operations, highly utilized to drive down COGs, and
compliant to the wide range of global GMP/regulatory requirements.
These facilities should also have the capability to be adapted to support
the entire range of manufacturing support, from clinical materials to commercial product. This is a tremendous shift in the manufacturing paradigm
from just ten years ago, where facilities were focused on a primary product
or “similar” process unit operations that could potentially deliver a limited
menu of multi-products based around a central process platform.
We can achieve these attributes today due to the enabling technologies
mentioned above. These technologies have allowed companies to reduce
the change-over time
and effort, reduce
cleaning and clean-
ing validation time
and costs, reduce
ments and therefore
space needs, and pro-
vide lower costs for
The new facility
will focus on this
Closed systems and
gy will result in more
use of CNC space and
that incorporate “ballroom” concepts.
Adaptibility will include rooms/suites that
can house any number of different unit opera-
tions where scheduling of activities will beoc-
me much easier and efficient. Reconfiguration
of layouts to accomodate significant changes
in technology and/or scale-out capability will
allow for ease in moving into larger commercial
How this new generation of biomanufacturing facil-
ities will be delivered represents the final shift in the facility
component of the biomanufacturing paradigm. Rapid deployment,
modularity, flexibility, and adaptability are again attributes of the
new delivery paradigm. Facility concepts are being developed around
unique platforms where the integration of traditional architectural and
infrastructure elements results in facilities that can support the new bio-
manufacturing models in terms of scale, area classification, and product
protection. While these types of facilities will not address 100% of all
biomanufacturing needs, they will provide a giant step toward fulfilling
the strategic needs of many biomanufacturing enterprises.
The paradigm shift is evident. Will your company be ready to meet
the challenges future products and business parameters will require?
The key to success will be dependent on how well companies understand their product/process attributes, transfer that knowledge to the
facility elements and have an overall understanding of quality and risk
with respect to the paradigm and technology shifts. The tools available
today to create strategic solutions to meet business needs are greater
than at any time in the past 40 years. The 2014 INTERPHEX Tour vendors are companies that provide these technologies that will become
part of that strategic solution in the next decade.
14 FEBRUARY 2014 ◗ pharmpro.com