3D printing is a gamechanger in drug
manufacturing, as it gives industries
the ability to fully customize medicines
- mostly oral solid dosage forms - with
realistic production costs.
Instead, in FDM, manufacturers first design
a 3D theoretical drug model. Secondly,
they choose appropriate printing process
parameters, such as layer thickness, extruder
diameter, base plate, extruder temperature,
printing and extrusion speed. Subsequently,
the 3D printing machine reads the models
and executes the commands in order to
produce the final product.
Therefore, to deliver personalized
medicaments with specific drug properties,
manufacturers must have a thorough
understanding of the different 3D printing
processes involved and how they affect the
final drug attributes. In this way, they can
plan, control and fine-tune the relevant
mechanisms to suit.
QbD is a prerequisite for precision medicine
Process understanding and monitoring,
typical of additive manufacturing of
pharmaceuticals, are also the foundations
of QbD. This model focuses on designing
quality into a product from the earliest
stages of planning - controlling critical
process parameters (CPPs) at any point on
the manufacturing line in order to affect the
drug’s critical quality attributes (CQAs). In this
way, manufacturers can be certain that the
end product satisfies a set pharmacological
specification and complies with regulatory
requirements.
Whilst the processes involved in 3D printing
of pharmaceuticals greatly differ from
traditional preparations, the PAT process
used to support the QbD approach remains
the same. More precisely, multivariate non-
destructive analysis, such as colorimetry,
chemical hyperspectral imaging, infrared,
near-infrared and Raman spectroscopy,
can be integrated in the printing system as
in-line, real-time quality control tools. In this
way, drug manufacturers can monitor CQAs
and adjust CPPs accordingly.
In order to efficiently monitor the 3D printing
line and delivery accurate personalized
medicines, it is important to implement a
system that can gather, analyze and store
analytical and process measurements. Then
use these to create and validate models,
generate predictions based on these models
and provide feedback to the 3D printing
system. In this way, manufacturers are
empowered with clear actionable insights.
What is called for is a PAT knowledge
management tool, a leading solution
being Optimal’s synTQ. This is used by over
half of the top ten global pharmaceutical
manufacturing companies, as it offers a
regulatory-compliant, user-friendly platform
to detect when a process is moving out of its
optimum operating window and correct the
relevant CPPs live and in-process.
Taking drug 3D printing to the next level
PAT is fundamental to making this a
quantum leap in 3D printing of medicines.
In fact, this technology is not limited to
batch processing, as continuous additive
manufacturing, whilst in its infancy, can
also be implemented. By adopting this
continuous manufacturing approach, 3-D
printers can reduce production times and
costs even further by enabling the real-time
release of regulatory compliant drugs.
To shift from batch to continuous printing,
it is necessary to install reliable and robust
PAT along the entire system. In this way,
CQAs of each single personalized drug can
be monitored at all times. A consequence of
continuous manufacturing is the generation
of even larger volumes of process data.
Therefore, PAT knowledge management
platforms, such as synTQ, hold an even more
central role.
Additive manufacturing is beginning to
gain interest among the pharmaceutical
industry, as its opportunities, benefits and
successes become more and more apparent.
As its visibility increases and its technology
matures, especially strengthening the
continuous processing capabilities, its
adoption will become ever more widespread.
So will PAT, which is already becoming a new
industry standard, as this is the key tool to
ensure that personalized drugs fulfil their
specific pharmacological and regulatory
requirements. By choosing a well-accepted
PAT knowledge management software tool
like synTQ, additive manufacturers can call on
a solid, customizable solution to build new
production processes upon.
www.optimal-ltd.co.uk
Issue 39 PECM
21