A6 - A 3D printer for every pharmacy?

Conference Hall B1

Organised by FIP’s Industrial Pharmacy Section, in collaboration with the Community Pharmacy Section and the Hospital Pharmacy Section

Chairs

Gabrielle Wiederkehr (ACCESS Regulatory Consulting GmbH, Switzerland) and Robert Moss (FIP HPS, The Netherlands)

Introduction

When will a pharmacist be able to use each patient’s individual information — such as age, race, gender or constitution — to produce their optimal medication dose, rather than relying on a standard set of doses? Could there be a time when a pharmacist will be able to print drugs in a complex construct of layers, using a combination of substances to treat multiple ailments at once, so that patients receive a single pill to treat every illness they have?

Compared with other technologies, 3D printing has played a minor role in health care so far, with sporadic highlights such as the first US Food and Drug Administration-approved 3D-printed drug in August 2015 and experiments at University College London to produce tablets in dinosaur or octopus shapes, making tablet-taking more attractive to children.

These days, pharmaceutical companies are investing more in 3D printing technology. It has proven to be a way of prototyping new products in a cost-efficient and effortless manner. In addition, the technology is now moving into a new realm: printing the finished drugs themselves. The new pills can be tailored to patients in terms of its dose, size, appearance and delivery, making drugs safer and more effective.

Other drivers for 3D printing of oral medicines include on-demand capability, ability to manufacture in decentralised locations, for example, in case of remote pandemic events, for military applications or preclinical drug supply with flexible doses within a translational pharmaceutics framework.

The technology of 3D printing is easy enough to become a common healthcare practice. Until now however, safety and security concerns have prevented it from entering pharmacies and hospitals; as the technology is still new, there are regulatory issues and a lack of regulations. How will good manufacturing practice compliance, product quality and release, traceability be assured? Other questions are how would the raw material get to the decentralised manufacturing sites? The specialty nature of active ingredients limits suppliers and the need to ship them could reduce benefits of local manufacture.

Programme

14:30 – 14:40 Introduction by the chairs

  1. 14:40 – 15:15 How does 3D printing of drugs work?
    Mary Kyobula (Astra Zeneca, UK)
  2. 15:15 – 15:50 Personalised 3D-printed medicines: Perspectives and challenges for the hospital pharmacy
    Josep Guiu (University of Barcelona, Spain)

15:50 – 16:10 Coffee/tea break

  1. 16:10 – 16:45 Challenges and opportunities of 3D-printed drugs from the regulators’ perspective
    Ahmed Zidan (CDER Division of Product Quality Research FDA, USA)
  2. 16:45 – 17:20 3D printing as an advance in personal healthcare – Pharmaceuticals and medical devices
    Michael Anisfeld (Globepharm Consulting Inc, USA)

17:20 – 17:30 Panel discussion and conclusion by the chairs

17:30 – 17:35 Room refresh

Learning Objectives

At the end of this session, participants will be able to:

  1. Describe 3D printing technology for drug printing
  2. Identify key drivers and opportunities for 3D printing of drug products
  3. Identify key barriers and issues to be addressed before 3D printing of drugs will become common practice
  4. Describe the impact of 3D printing on patients and the research and development-based pharmaceutical industry.

Type of session: Knowledge-based