1.
3D PRINTING
By:
Yash Vardhan
Lohia

2.
What is 3D Printing?
The basics of the technology.
1

3.
3D PRINTING
• 3D printing or additive manufacturing
is a process of making three
dimensional solid objects from a digital
file.
• 3-D printing is 2D printing—several
thousand times, where the printer
stacks layers to generate parts.

4.
3D PRINTING
• The creation of a 3D printed object
is achieved using additive processes.
In an additive process an object is
created by laying down successive
layers of material until the object is
created. Each of these layers can be
seen as a thinly sliced horizontal
cross-section of the eventual object.

5.
3D PRINTED MATERIALS
Decoratives
Architectural
Designs
Spare Parts
Automobiles

6.
How 3D Printing Works?
A step by step process.
2

7.
PROCESS
It all starts with making a virtual design
of the object you want to create. This
virtual design is for instance a CAD
(Computer Aided Design) file. This
CAD file is created using a 3D
modeling application or with a 3D
scanner (to copy an existing object). A
3D scanner can make a 3D digital copy
of an object.

8.
3D SCANNERS
• 3D scanners use different
technologies to generate a 3D
model.
• Examples are: time-of-flight,
structured/modulated light,
volumetric scanning and many
more.

9.
3D SOFTWARE
• 3D modeling software also comes in
many forms. There’s industrial grade
software that costs thousands a year
per license, but also free open
source software, like Blender, for
instance.

10.
3D MODEL TO 3D PRINTER
• A 3D model is prepared before it is
ready to be 3D printed. This is what
they call slicing.
• Slicing is dividing a 3D model into
hundreds or thousands of horizontal
layers and needs to be done with
software.
• When the 3D model is sliced, you are
ready to feed it to your 3D printer.

11.
3D PRINTING IN
PHARMACEUTICALS
The latest innovations
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12.
Imagine a pediatrician talking to a four-year-old
child who is having trouble adjusting to taking daily
doses of steroids after being diagnosed with
Duchene muscular dystrophy the previous month.
“What’s your favorite animal?” she asks. “A zebra,”
quietly replies the child, who we will call Sam. The
pediatrician smiles as she makes a note on her
office computer. “But not a black and white one, a
blue and green one,” adds Sam, with a little more
confidence. Later, the toddler watches with wide
eyes as the uniquely colored, zebra-like tablets
appear from a three-dimensional (3D) printer in the
hospital pharmacy.

13.
THE CHANGE...
• The role of medicines in healthcare systems
globally is becoming more important.
Innovative treatments become available to
address unmet clinical needs at the same
time that economic development and the
imperative of universal health coverage
become drivers of expanded access.
• In 2014 it is estimated that the global
spending on medicines exceeded $1 trillion
for the first time. The amount is projected to
reach $1.2 trillion in 2017.

14.
TECH AND INNOVATION
• New possibilities in 3D printing may
open up a whole new chapter of
opportunities for pharmaceutical
research and bio-technology
applications.
• There are a number of ways it could
be used — drug dosage forms,
supporting delivery, or helping to
research cures.

15.
CURRENT TRENDS
• Compared to other sectors, 3D
printing technology has played a
minor role in healthcare so far. Experts
assume that healthcare only
accounted for 1.6 percent of all
investments made into the $700
million 3D printing industry. However,
that number is expected to grow to 21
percent over the next 10 years.

16.
CURRENT
TRENDS
Applications such as dental
implants have already been
very successful commercially:
It’s assumed that around
5,00,000 custom-fit
Invisalign braces are printed
on a daily basis.

17.
Current and Projected Uses
PERSONALIZED
DRUG
DOSING
UNIQUE
DOSAGE
FORMS
COMPLEX
DRUG RELEASE
PROFILES
PRINTING
LIVING
TISSUE

18.
PERSONALIZED DRUG
DOSING
• 3D printing could add a whole new
dimension of possibilities to
personalized medicine.
• In its most simplistic form, the idea
of experts and researchers is to
produce personalized 3D printed
oral tablets.

19.
• A doctor or a pharmacist would be able
to use each patient’s individual
information such as age, race and gender
to produce their optimal medication
dose, rather than relying on a standard
set of dosages.
PERSONALIZED DRUG
DOSING

20.
3D printing may also allow pills to be printed in a
complex construct of layers, using a combination
of drugs to treat multiple ailments at once. The idea
is to give patients one single pill that offers
treatment for everything they need.

21.
COMPLEX DRUG
RELEASE PROFILES
• Designing and printing drugs firsthand
makes it much easier to understand their
release profiles. 3D printing makes it
possible to print personalized drugs that
facilitate targeted and controlled drug
release by printing a binder onto a matrix
powder bed in layers.
• This creates a barrier between the active
ingredients, allowing researchers to study
the variations of the release more closely.

22.
PRINTING
LIVING TISSUE
While it’s not likely that this will
possible on a full scale anytime
soon, experts project that
science is less than 20 years
away from a fully functioning 3D
printed heart. But for now, 3D is
still challenged by intricate
nature of vascular networks.

23.
According to Tony Atala, director of
the Wake Forest Institute for
Regenerative Medicine, each organ
presents a different level of
complexity. So while some tissue
would be much easier to print — such
as flat structures, like human skin —
the most difficult areas in organ
printing are the heart, liver and
kidneys.

24.
3D PRINTING INNOVATIONS
Products now in use.
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25.
APRECIA ZIP DOSE
• Powder-liquid three-dimensional printing
(3DP) technology was developed at the
Massachusetts Institute of Technology
(MIT) in the late 1980s as a rapid-
prototyping technique. This technology
uses an aqueous fluid to bind together
multiple layers of powder using a unique,
patent-protected process to create a wide
range of products.

26.
BRINGING ZIP DOSE®
TECHNOLOGY TO LIFE
• Aprecia developed the ZipDose® platform,
which is designed to enable delivery of
high-dose medications in a rapidly
disintegrating form.
• ZipDose® Technology produces a product
layer-by-layer without using compression
forces, punches, or dies.

27.
ZIP DOSE MECHANISM
• First, a powder blend is deposited as
a single layer. Then, an aqueous
binding fluid is applied and
interactions between the powder and
liquid bind these materials together.
• This process is repeated several times
to produce solid, yet highly porous
formulations, even at high dose
loading.

28.
KEY FEATURES
Aprecia’s ZipDose® products are
designed to:
• Rapidly disintegrate on contact with
liquid by breaking the bonds created
during the 3DP process.
• Support dosing upto 1000mg/1gm.
• Allow the application of enhanced
taste-masking techniques.

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31.
BIO BOTS
U.S. biotech startup BioBots sits
at the intersection between
computer science and chemistry.
Its debut product, a desktop 3D
printer for biomaterials, combines
hardware, software and wetware.

32.
BIOFABRICATION
• Biofabrication, the process of artificially
building living tissue structures, is not a
new field — there is more than a decade
of research in this area already.
• Instead of plastic, BioBots’ 3D printer
uses a special ink that can be combined
with biomaterials and living cells
to build 3D living tissue and miniature
human organs.

33.
RISKS IN 3D PRINTING
Threats in moving forward.
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34.
PRODUCT
LIABILITY RISK
• Pharmaceutical companies need to consider
the potential product liability implications.
Based on its role in providing the product
blueprint alone, the firm may be partially
responsible if an adverse incident or product
defect claim arises.
• In fact, parties across the manufacturing
spectrum could be liable for the fallout. This
might also include the printer manufacturer,
the software designer, the material suppliers
and the product manufacturer.

35.
• There is no litigation in this area yet, and
therefore no precedent – so it’s unclear which
parties will be most susceptible to product
liability claims. Pharmaceutical companies
venturing into 3D printing should develop a
strategy for licensing their blueprints to
ensure they’re financially and legally
protected. The first conversations should
include their lawyers and insurance brokers.
PRODUCT
LIABILITY RISK

36.
CYBER RISK
• The proliferation of counterfeit
medicines is perhaps the industry’s
greatest concern with 3D printing.
Printers are much more vulnerable
to hackers than traditional
manufacturing processes, and the
incredibly short production time
magnifies the risk of counterfeits.

37.
CYBER RISK
For example, a hacker gaining access to a
drug maker’s proprietary blueprint could
bring the instructions to a manufacturing
plant overseas to mass produce the drug.
This exploitation of intellectual property
could have a significant impact on a
company’s bottom line. Plus, improperly
made drugs may go to market and cause
harm to patients – hitting the company’s
financials and reputation.

38.
SAFETY AND EFFICACY
OF 3D PRINTERS
The idea of individualized medicine –
whereby a patient’s age, weight, race or
organ function could inform doses and
production – has captivated medical
community since 3D printing became a
reality. But the possibility of a printer
defect or manufacturing malfunction
remains a concern, as does placing
responsibility for such an incident.

39.
SAFETY AND EFFICACY
OF 3D PRINTERS
Importantly, 3D printing manufacturers
must be diligent about vetting their
suppliers, as contaminated or defective
materials may yield a faulty product
and pose an even larger threat than the
printers themselves.

40.
CONCLUSION
• 3D printing technology has the
potential to open doors in product
development, manufacturing and
distribution for pharmaceutical
companies. It could help fulfill the
promise of personalized medicine, a
concept that is growing in popularity
within the industry.

41.
CONCLUSION
• For a firm considering a future in 3D printing,
understanding risk exposures should be one of
the first steps in determining whether it's a
worthwhile investment.
• Pharmaceutical companies should work closely
with their IT and manufacturing colleagues to
understand the risks, and then tap into
insurance experts, their broker and
underwriters to ensure that insurance
coverage is properly crafted to address the risk
exposures.

42.
REFERENCES
• https://3dprinting.com/what-is-3d-printing
• http://blog.ispe.org/3d-printing-pharmaceutical-manufacturing
• https://redshift.autodesk.com/3d-printed-pharmaceuticals/
• https://www.aprecia.com/zipdose-platform/3d-printing.php
• http://www.pharmaceutical-journal.com/news-and-
analysis/features/3d-printing-the-future-of-manufacturing-
medicine/20068625.article
• https://thenextweb.com/insider/2016/03/29/3d-printing-changes-
pharmaceutical-world-forever/
• https://www.3dmpconference.com/
• http://www.pharmtech.com/vision-3d-printing-pharma-manufacturing
• http://www.computerworld.com/article/3048823/3d-printing/this-is-
the-first-3d-printed-drug-to-win-fda-approval.html
• http://www.pharmamanufacturing.com/articles/2016/three-big-risks-in-
3d-printing-pharmaceuticals/
• YouTube links embedded.

43.
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