Describes the factors creating the need for greater flexibility in sterile injectable manufacturing, problems with conventional aseptic filling technologies and innovations that provide a flexible, scalable model for pharmaceutical manufacturing.

1. 21st Century Manufacturing of
Injectable 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 benefits
Key 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 Ompi
6. 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.com
Vanrx Pharmasystems Inc.
#200 - 3811 North Fraser Way
Burnaby, BC V5J 5J2 CANADA
+1.604.453.8660
This infographic explores the factors changing the development and production of sterile
injectables. 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 of
current 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