The most critical period for a new facility is often the
initial planning phase, before major commitment of
capital funds. Our firm has expertise in basic
science, cell culture technology and its scale-up,
manufacturing facilities and regulatory requirements.
This range of experience may be helpful in bridging
discussions between development scientists and the
non-science based professionals required for
construction of a manufacturing facility.
We are able to assist emerging
biotechnology companies and academic organizations
develop a conceptual facility design for their initial
pilot or commercial scale manufacturing facility.
This conceptual plan is suitable for presentation to the
FDA/CBER and for discussions with the
architect/engineering professions that will prepare the
detailed design and construction documents. We
have designed 40 manufacturing facilities (30 for cell
and gene therapy).
There are a number of tasks that
must be accomplished during this initial planning period
for the design:
Definition of the manufacturing
process or processes that the facility is planned to
support. A detailed process description
document should be prepared. Is the facility
intended to support multiple product manufacture on
a campaign or on a simultaneous basis?
Regulatory requirements are different for single
product facilities vs. multiproduct
facilities. Will the facility make
"patient-specific" products or will single product
lots be used for multiple patients? The scale
of manufacturing equipment, number of production
rooms, FDA concerns for cross-contamination /
product mix-ups and other issues will be different
for patient-specific manufacturing.
One issue that has major
regulatory implications is whether viral vaccines or
viral vectors will either be used or produced during
the manufacturing process. The FDA has
stringent requirements for the handling of live
viral substances, which will be a major concern for
the facility design.
Consideration of the scale of
manufacturing and type of production technology that
will be employed are important facility design
criteria. For initial manufacturing
facilities, the technology for and scale of
production is often a bridge between the research /
pre-clinical levels and the eventual commercial
operation. There are significant regulatory
considerations that are important in choosing an
appropriate scale of operations and level of
Delineation of the maximum
capacity for the facility in amount of product and
the number of product lots that may be produced
annually is also important. Will the facility
be designed for future expansion or for multiple
shift operations? Will the facility only be
used for clinical Phases 1 and 2 or will it support
Phase 3 and commercial manufacturing? These
decisions have major regulatory implications.
Our firm will develop a facility
design which meets both the manufacturing process
requirements and the FDA's facility concerns for
cGMP/GTP/QSR compliance. We recommend that this
conceptual design be presented to the FDA in a "Type C"
design meeting with the Division of Manufacturing
and Product Quality.
Example room layouts and facility
flow diagrams for a pilot gene therapy facility are
shown on the WebPages indicated by green buttons at the
top of this page. A larger cell therapy facility
is shown below.
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