EDITOR’S CHOICE
THREE-DIMENSIONAL PRINTING
OPTIMAL INDUSTRIES
PAT MINIMIZES REGULATORY CONCERNS
AROUND 3D-PRINTED MEDICINES
Three-dimensional (3D) printing is revealing
its potential in the pharmaceutical industry
as it turns personalized medicine into
reality. In fact, additive manufacturing has
the unique ability to deliver quickly, flexibly
and economically set amounts of patient-
specific drugs with bespoke properties, such
as formulations, dosages or geometries.
To achieve that and meet strict regulatory
requirements, the pharmaceutical industry
needs to set-up solid Quality by Design
(QbD) strategies and process analytical
technologies (PAT).
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.
20
PECM Issue 39
Martin Gadsby, Director at Optimal Industrial
Technologies, looks at how PAT is key to
success in additive manufacturing of drugs.
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. In this way, patients can
be treated with more specific dosages and
drug combinations that fully address their
needs. Even more, this technology empowers
pharmaceutical industries to develop
medicines with sophisticated bio-functional
constructs, which are not achievable with
traditional manufacturing practices.
The methods used to produce 3D-printed
drugs, or “printlets”, conform to
conventional additive manufacturing
technologies, such as inkjet printing or
fused deposition modelling (FDM). In
these systems, the product is often built
by depositing highly accurate doses of
material layer by layer, until a 3D shape is
formed. As a result, reproducibility is a key
feature and conventional pharmaceutical
manufacturing operations, such as milling,
granulating or compressing, do not take
place in additive manufacturing.