A REVIEW OF REUSABLE AUTO-INJECTORS FOR BIOLOGICAL & BIOSIMILAR DRUGS
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E3D – Elcam Drug Delivery Devices
A REVIEW OF REUSABLE
AUTO-INJECTORS FOR
BIOLOGICAL & BIOSIMILAR DRUGS
In this article, from the perspective of the growing biologics and emerging biosimilars
markets, Menachem Zucker, PhD, Head and Founder of E3D – Elcam Drug Delivery
Devices (a sister company of Elcam Medical ACAL), showcases the company’s
mechanical and electronic auto-injector platforms, both of which are reusable devices
with disposable cassettes.
A GROWING NEED FOR
BIOLOGICS & BIOSIMILARS “The disposable cassette design
When generic drugs began to be can be customised to incorporate
introduced 30 years ago, they standard glass prefilled syringes
revolutionised the pharmaceutical
from different manufacturers,
industry. Now, many ask if
biosimilars will have the same including dual-chamber syringes.
impact. Since the approval A vial adapter is also currently in
of the first biosimilar drug in
development, which will enable
2015 this approach is becoming
ever more prominent in drug reconstitution and mixing.”
drug development. Healthcare
Recruiters International (San
Francisco, CA, US) suggest a figure of – such as multiple sclerosis, diabetes or
US$250 billion (£185 billion) in drug growth hormone disorders - requiring daily
cost savings1 if 11 bio-similar drugs are doses (sometimes multiple times a day)
approved by the US FDA. The same source for treatment success, then reusable auto-
claims that biosimilars have been lowering injectors are the sensible solution. Reusable
healthcare costs globally since 2006 with auto-injectors increase safety and ease of
no known safety issues. Another report, use, they reduce the volume of storage
by SNS Telecom (Dubai, UAE), claims that and waste footprint (and are thus more
by the end of 2020 approved biosimilar environmentally friendly) and they are also
drugs will account for nearly $22 billion in significantly more cost effective.
revenue.2 According to Dyadic (Jupiter, FL,
Dr Menachem Zucker
US) the market for therapeutic biological GENERATIONS OF REUSABLE Head & Founder
drugs will soar to $287 billion by 2020.3 AUTO-INJECTORS T: +972 4 698 8120
These numbers are only a first indicator of F: +972 4 698 0777
the clear demand for, and true potential of, E3D (a sister company of Elcam E: menachem@elcam.co.il
biologicals and biosimilars. Medical) specialises in the development
Both biological drugs and biosimilar and production of high-quality, patient- E3D – Elcam Drug Delivery Devices
drugs are typically fragile proteins, calling compliant auto-injectors. The company sees (a sister company of
for administration by injection. Auto- its products as the next step in effective Elcam Medical ACAL)
BarAm 1386000
injectors therefore increase the therapeutic care. E3D offers two generations of
Israel
value of the drug. When these drugs are reusable auto-injectors, which are currently
prescribed for people with chronic diseases under development. www.elcam3d.com
64 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd
E3D – Elcam Drug Delivery Devices
Figure 1: E3D Flexi-Q-mMU, reusable auto-injector.
Mechanical Multi-Use Auto-Injector at assembly to further reduce patient disposable cassette
The E3D Flexi-Q-mMU comprises a anxiety, needle phobia and perceived reduces the storage
reusable driving unit and a disposable pain. As soon as the patient lifts the footprint for both
cassette (Figure 1). The cassette is cost injector from the skin the needle shield is manufacturing and
effective and can be used with standard lowered and the cassette jumps partly out, delivering the product. The
prefilled syringes (PFS) and vials (using an ready for disposal. storage volume is also reduced at
adapter). The disposable cassette design can be the patient’s home, as is waste. In fact, the
The Flexi-Q-mMU reusable auto-injector customised to incorporate standard glass disposable cassette’s waste footprint is four
is designed with patient compliance in mind. PFS from different manufacturers, including times (4X) smaller than that of a disposable
The product is easy to use (with just one dual-chamber syringes. A vial adapter is injector. Due to its smaller size, the amount
additional preparation step when compared also currently in development, which will of plastic used is also reduced, the benefits
with a fully disposable injector). All the enable drug reconstitution and mixing. of which in terms of production costs and
patient has to do is: The reusable injector is an the environment are clear.
environmentally friendly product on Using a disposable cassette rather than
1. Insert cassette into the driving unit a number of levels (see Figure 2). The a disposable auto-injector reduces the
2. Remove safety cover
3. Press against skin
4. Press the INJECT button.
A two-step mechanism for enhanced
safety was designed: drug delivery can
only take place when both the skin sensor
and the INJECT button are activated.
This way only when the auto-injector is
pressed to the skin (and when the patient
is ready) can the button be pressed and the
injection take place.
Safety is further enhanced as the patient
will have two indications for the end of
injection. Firstly, they will hear a click when
the injection is completed and, secondly,
the patient can monitor the process through
the injection window.
The needle is hidden during the entire
injection process. It only emerges when
the auto-injector is touching the skin and
the INJECT button is pressed. Injection is
a quiet process and injection speed/time
can be pre-set by the pharma company Figure 2: Footprint and environmental impact.
Copyright © 2017 Frederick Furness Publishing Ltd www.ondrugdelivery.com 65
E3D – Elcam Drug Delivery Devices
cost per injection. The cost ratio is 1:5, (Figure 3). The electronic version works
meaning a reusable auto-injector results in a with PFS and E3D also offers a version that “Time, quantity, drug type
saving of approximately 80%. The reusable is suited for cartridges (Flexi-Q-eMU-C).
unit is good for three years (approximately With Flexi-Q-eMU-P, self-injection
and whether a full or partial
1000 uses) and is easily disposed of. It thus is made even easier. The LCD screen injection was delivered
has a negligible effect on the environment provides the patient with a large display are all recorded and sent
and operation costs. where each stage of the injection process
is presented with clear instructions in real
from the auto-injector via a
Electronic Multi-Use Auto-Injector time. The patient is further empowered for wireless connection to the
E3D has taken all the advantages of effective care with reminders and injection cloud, per the definition of
reusable auto-injectors for effective care history (Figure 4).
mentioned above another step further with The disposable cassette also includes an
the drug company at the
its electronic version, the Flexi-Q-eMU-P RFID component, on which the pharma filling stage of production.”
company can encode the expiry date, anti-
fraud barcode, various permissions and
definitions and, of course, the drug name This is especially useful for patients who are
and dose. If the drug has expired or prone to forgetting their injection schedule.
is fraudulent the injector will warn Time, quantity, drug type and whether a
the patient, and will not allow the full or partial injection was delivered are all
injection to proceed. recorded and sent from the auto-injector via
The needle within the disposable a wireless connection to the cloud, per the
cassette is protected and hidden definition of the drug company at the filling
at all times in this version as well. stage of production. The pharmaceutical
In the electronic version, injection company may also make use of injection
is stopped as soon as the patient lifts data in order to improve its future products.
the injector from the body (even if A five-question survey following the
injection is not completed – so no drug injection can be defined as optional or
is lost – but the cassette becomes void). mandatory, helping to gather additional
Partial injections are recorded into the data regarding the injection process,
electronic log. patient symptoms and their reaction to
With a specialised mobile app (Figure 5), the drugs in real time. This information
the data regarding injecting habits and is especially important for the physician
patient compliance with the prescribed follow-up and its collection has never
treatment programme can be enhanced and been easier.
its delivery made even easier. The Further advantages of the electronic
auto-injector can automatically send product include measuring drug temperature
Figure 3: Flexi-Q-eMU-P, electric
patients, as well as doctors and family before injection is permitted and injection
reusable auto-injector and disposable
PFS-based cassette. members, reminders, logs and injection data. with a motor for better control of injection
Figure 4: Injection stages and instructions on screen, reminders, data and history display.
66 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd
E3D – Elcam Drug Delivery Devices
Figure 5: E3D auto-injection app.
creating considerable operational cost
savings. Home care drug delivery and
self-injection help the healthcare industry
save on hospitalisation and grant the patient
speed and reduced pain. Out-of-date Our products are designed in accordance enhanced independence via self-treatment.
cassettes cannot be used. Drugs with high with our belief that drug companies will The electronic generation of reusable
or low viscosity (or anything in between) have a growing need for auto-injectors auto-injectors takes these traits even further.
can be all injected using the same platform. that are customised to their products, By enabling full supervision of the amounts
The product can also be customised their brand and to their user’s needs and of drug used, injection logs, reminders
for marketing and commercialisation. treatment programmes. to patients, reports to family members
The front panel is available in different and physicians, every participant in the
colours and designs for branding purposes, PHARMA GROWTH ACCORDING TO entire healthcare system can become more
as well as for fun. A music feature can be DRUG DELIVERY MARKET TRENDS involved (even at a distance), thus providing
enabled for targeting younger users. enhanced and effective care.
Three of the most significant demands The software enables control of dosage
AUTO-INJECTOR SUPPLY CHAIN driving the growth of drug delivery system and other therapeutic factors, customising
development, in addition to increasing the them to personal patient needs after a
At E3D we know that flexibility and commercial value (and lifecycle) of the specific follow-up of injection logs and
customisation are keys to success (we even drug, are: analysing the therapeutic results attained.
named our product line FLEXI). We know This is just a step away from precision (or
that the selection of drug delivery devices • Demand for improved patient compliance personalised) medicine. Adjustments can
depends on several factors, including and quality of care be made by patients, doctors or both,
formulation, primary package, dosing and • Growing awareness of production costs, depending on parameters predefined by the
safe, effective usage. Our products are both financial and environmental drug company. This means that the highest
designed to suit varying needs so that each • Self-administered drug therapy (another quality treatment can be easily administered
drug company can find the auto-injector step towards precision medicine and from a distance.
best suited to its requirements. telemedicine). Throughout the development process
E3D provides drug companies with all for its auto-injectors, E3D conducted
the components and machinery required to E3D reusable auto-injectors, of formative usability tests involving patients
complete the assembly of the disposable both generations, answer these trends. form various groups (gender, age, illness,
cassette with the drug PFS (or cartridge), The products are designed to provide each disability, etc). Issues such as auto-injector
branding and labelling, all in accordance patient with effective care according to shape, convenience and ease of use, location
with the company’s own requirements. their own specific treatment programme. of buttons, size of display and ideal ratio
The drug know-how and production thus By making the product safe and between injector width and display size
remains fully under the pharmaceutical easy to use, reducing needle phobia, were tested and optimised. After integrating
company’s control. ensuring delivery of the full dosage and the test recommendations into the product
enabling better therapy follow-up, design, repeated tests resulted in high
E3D provides: the quality of care, patient safety and satisfaction with regards to holding the
patient compliance are all increased. injectors, display size and ease of use.
• Reusable auto-injector units Reusable auto-injectors reduce both At E3D we develop and manufacture our
• Disposable cassette components the storage and waste footprint, for both products according to required regulations
• Automatic final assembly machine for the manufacturers and patients, thus reducing and relevant standards. With our sister
cassette with the drug PFS (or cartridges) environmental impact. Disposing of only company Elcam Medical’s know-how in
• Software for electronic labelling the cassette and not the entire injector injection and moulding, plus its automated
(RFID chip on cassette). reduces the cost per injection significantly, assembly capabilities, and by embracing
Copyright © 2017 Frederick Furness Publishing Ltd www.ondrugdelivery.com 67
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ABOUT THE COMPANY
2017/18
E3D is a sister company of Elcam Medical
ACAL, developing and manufacturing
auto-injectors and patch pumps for
biologic and biosimilar drugs, utilising the
moulding injection and assembly know-
how, engineering and technologies of Elcam
Medical as well as its well-established
EDITORIAL CALENDAR
quality assurance and quality control. E3D
believes in a growing need for customised
auto-injectors that enhance the therapeutic
Publication Issue Topic Materials
Month Deadline
and commercial value of drugs and their
lifecycles. Customisation and flexibility are
at the core of its product development. DEADLINE
Nov 2017 Pulmonary & Nasal Drug Delivery
PASSED
REFERENCES
Nov 13th
1. “Biosimilars Market in the US – Dec 2017 Connecting Drug Delivery
2017
2015; Are biosimilars set to disrupt
the US pharmaceutical industry?
Healthcare Recruiters International Nov 20th
Jan 2018 Ophthalmic Drug Delivery
Web Page, September 30th, 2015. 2017
(www.hcrnetwork.com/biosimilars-
market-in-the-us-2015) Prefilled Syringes & Dec 22nd
Feb 2018
2. “The Biosimilar Drugs Market: Injection Devices 2017
2016 – 2030 – Opportunities,
Challenges, Strategies & Forecasts”.
Skin Drug Delivery: Jan 20th
SNS Telecom Consulting Company Mar 2018
Dermal, Transdermal Microneedles 2018
Report Synopsis, September
2016. (www.snstelecom.com/
biosimilardrugs)
Feb 19th
Apr 2018 Pulmonary & Nasal Drug Delivery
3. Emalfarb M, “The C1 Expression
2018
System Reinventing Biologic Drug
Production”, Company Presentation, Injectable Drug Delivery: Mar 19th
May 2018
Dyadic, January 3rd, 2016. Devices Focus 2018
April 23rd
ABOUT THE June 2018 Connecting Drug Delivery
2018
AUTHOR
May 21st
Joining Elcam Medical ACAL in 2002, July 2018 Novel Oral Delivery Systems
2018
Menachem Zucker served as Vice-
President of Business Development,
Marketing and Sales. In 2010, he July 23rd
Sept 2018 Wearable Injectors
initiated the E3D activity and since 2018
then serves in the role of Vice-President
and Head of E3D. Previously the Chief Prefilled Syringes & Aug 27th
Oct 2018
Executive of Opgal Medical (Israel), Injection Devices 2018
he led the development of simulation
products for cardiac surgery. He also Sept 24th
founded a company for catheterisation Nov 2018 Pulmonary & Nasal Drug Delivery
2018
closure devices. Dr Zucker holds a PhD
from Imperial College London, which
Oct 29th
he obtained in 1990. Dec 2018 Connecting Drug Delivery
2018
68 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd
Flexi-Q eMU-C Electrical Multi-Use Auto-Injector for biological drugs in cartridges and dual chambers T E W
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