21st Century Manufacturing ofInjectable Pharmaceuticals

The Need for Greater Manufacturing Agility

Number of Therapies Product Launches Container Variety

Issues with Conventional Fill-finish

• Regulatory demands for manufacturing modernization

• Shorter product lifecycles and increased competition

Custom designs:

Inflexible, long build timelines, high costs, hard to replicate

Built for blockbusters:

High throughput, slow changeover, single container format

Key benefitsKey differences vs.

conventional systems

Best therapies for the Workcell Approach

References:1, 2: QuintilesIMS. Outlook for Global Medicines through 2021. URL: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/outlook_for_global_medicines_through_2021. Accessed: December 8, 2016.3: Kopcha, M. “Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs.” URL: http://blogs.fda.gov/fdavoice/index.php/2016/02/modernizing-pharmaceutical-manufacturing-to-improve-drug-quality-ensuring-a-safe-and-adequate-supply-of-drugs/. Accessed: December 8, 2016.4. IMS Institute for Health Informatics. “Delivering on the potential of biosimilar medicines.” Published: March 2016. URL: http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf. Accessed: December 8, 2016.5. Image courtesy of Ompi6. Image courtesy of ARaymondilfe

The Aseptic Filling Workcell Approach

Vanrx Pharmasystems makes the most technologically advanced sterile filling solutions for the pharmaceutical industry. Vanrx fill-finish machines use isolated robotics and machine vision to automate the packaging of injectable drugs into nested vials, syringes, or cartridges. The company was founded by pharmaceutical industry veterans to create the systems needed to make the next generation of innovative therapies.

About Vanrx Pharmasystems www.vanrx.comVanrx Pharmasystems Inc.#200 - 3811 North Fraser WayBurnaby, BC V5J 5J2 CANADA

+1.604.453.8660

This infographic explores the factors changing the development and production of sterileinjectables. To learn more, download the white paper at www.vanrx.com/whitepaper.

of drug shortages caused by manufacturing and quality issues3

2,245 therapies in late-stage clinical development1

new therapies launched annually through 2021245

65%$44BValue of biologics losing patent protection between 2015-2020.4

There's more competition and smaller patient populations. We need to get to the market first and invest in flexibility.

The therapies we're making are more complex, but we're working with old approaches and equipment.The aseptic issues of 20 years ago are still there.

We need flexibility and superior process control to bring new therapies to patients. What is the state of the art for fill-finish?

1. Oncology / cytotoxics / antibody drug conjugates (ADCs), monoclonal antibodies

2. Novel biologics and biosimilars

3. Any high-mix, multi-product facility: e.g. CMOs for clinical and small-scale commercial fill-finish or generics

4. Drugs of the future, including cell therapies and personalized medicine

Aseptic issues:

Glove ports, operator interventions, particle generation

Focus on value-added work: uses only nested, ready-to-use containers5

Press-fit vial closures simplify capping and eliminate particles vs. aluminum crimp caps6

Scale out, not up, with additional workcells. Add capability for new recipes through software changes. Much smaller space needed.

1. Faster to market: build and scale out quickly. Ready, flexible manufacturing capacity for fill-finish.

3. Fixes aseptic processing issues with gloveless robotic approach

2. Meets needs ofcurrent low volume, high value pipelines: Vial / syringe / cartridge flexibility with fast changeover

4. Standard design for fast build, deployment and validation. Reduced infrastructure, floor space and personnel requirements.

Vanrx Workcell

Conventional Isolator

Design Fabricate Integrate Qual / Val

Fabricate Qual / Val

An integrated combination of gloveless isolator and filling robotics. Provides superior aseptic assurance and quality for high-value therapies.

YET ONLY