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3D PRINTINGBy:Yash Vardhan Lohia

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

3D PRINTING3D printing or additive manufacturing is a process of making three dimensional solid objects from a digital file.3-D printing is 2D printingseveral thousand times, where the printer stacks layers to generate parts.

3D PRINTINGThe 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.

3D PRINTED MATERIALSDecorativesArchitectural DesignsSpare PartsAutomobiles

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

PROCESSIt 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.

3D SCANNERS3D scanners use different technologies to generate a 3D model. Examples are:time-of-flight, structured/modulated light, volumetric scanning and many more.

3D SOFTWARE3D modeling software also comes in many forms. Theres industrial grade software that costs thousands a year per license, but also free open source software, likeBlender, for instance.

3D MODEL TO 3D PRINTERA 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.

3D PRINTING IN PHARMACEUTICALSThe latest innovations3

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. Whats 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.

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.

TECH AND INNOVATIONNew 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.

CURRENT TRENDSCompared 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.

CURRENT TRENDSApplications such as dental implants have already been very successful commercially: Its assumed thataround 5,00,000custom-fit Invisalign braces are printed on a daily basis.

Current and Projected Uses

PERSONALIZEDDRUG DOSINGUNIQUE DOSAGEFORMSCOMPLEXDRUG RELEASEPROFILES

PRINTING LIVINGTISSUE

PERSONALIZED DRUGDOSING3D 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.

A doctor or a pharmacist would be able to use each patients individual information such as age, race and gender to produce their optimal medication dose, rather than relying on a standard set of dosages.

PERSONALIZED DRUGDOSING

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.

COMPLEX DRUG RELEASE PROFILESDesigning 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.Thiscreates a barrierbetween the active ingredients, allowing researchers to study the variations of the release more closely.

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

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.

3D PRINTING INNOVATIONSProducts now in use.4

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.

BRINGING ZIP DOSETECHNOLOGY TO LIFEAprecia developed theZipDoseplatform, which is designed to enable delivery of high-dose medications in a rapidly disintegrating form.ZipDoseTechnology produces a product layer-by-layer without using compression forces, punches, or dies.

ZIP DOSE MECHANISMFirst, 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.

KEY FEATURESAprecias ZipDoseproducts 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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BIO BOTSU.S. biotech startupBioBotssits at the intersection between computer science and chemistry. Its debut product, a desktop 3D printer for biomaterials, combines hardware, software and wetware.

BIOFABRICATIONBiofabrication, the process ofartificially building living tissue structures, is not a new field there ismore 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 tobuild 3D living tissue and miniature human organs.

RISKS IN 3D PRINTINGThreats in moving forward.5

PRODUCT LIABILITY RISKPharmaceutical 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.

There is no litigation in this area yet, and therefore no precedent so its 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 theyre financially and legally protected. The first conversations should include their lawyers and insurance brokers.

PRODUCT LIABILITY RISK

CYBER RISKThe proliferation of counterfeit medicines is perhaps the industrys 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.

CYBER RISKFor example, a hacker gaining access to a drug makers 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 companys bottom line. Plus, improperly made drugs may go to market and cause harm to patients hitting the companys financials and reputation.

SAFETY AND EFFICACYOF 3D PRINTERSThe idea of individualized medicine whereby a patients 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.

SAFETY AND EFFICACYOF 3D PRINTERSImportantly, 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.

CONCLUSION3D 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.

CONCLUSIONFor 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.

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

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