Parenteral drug delivery is the second
largest segment of the pharmaceutical market and accounts for nearly 30% of the
market share. Currently, around 3.5 billion prefilled syringes are produced
each year and that number is growing between 9%-10% annually. The Future of
Alliances and Partnerships in the Prefilled Syringes Market to 2020 forecasts
that the global market for prefilled syringes will hit $6.6 billion in 2020, up
from $3.9 million in 2014.1
The surge is being attributed to an
increasing geriatric population, increasing demand for vaccines, increasing prevalence
of chronic diseases, and technological advancement in prefilled syringes. In
addition, the demand for point-of-care administration and regulations regarding
needlestick injuries are driving the growth of the global prefilled syringes
market.2
There is also a shift in demand for
biologics and biosimilars. In fact, nine of the top-10 drugs available in prefilled
syringes are now biologics and the majority of these are used for treating chronic
diseases such as diabetes, rheumatoid arthritis, and multiple sclerosis.
As the parenteral drug pipeline continues
to move from small molecules to complex biologics such as monoclonal antibodies
(mAbs) and antibody drug conjugates (ADCs), biological therapies provide unique
challenges for parenteral drug delivery, such as volume and viscosity.
Other challenges are prevalent as
well, including quality concerns, strict regulatory requirements, interaction
of prefilled syringes with drugs, manufacturing complexity, combination therapies,
and lyophilization. Additionally, aseptic processing of parenterals involves challenges
such as protecting the sterility of a product as it moves through each phase of
formulation, filtering, filling, and packaging.
Due to the complexities of syringe
manufacturing, the contractor market is growing. According to Frost &
Sullivan, sterile parenteral contract services make up about 82.8% of the total
sterile CMO market. This includes small-volume parenterals
(vials, ampoules, and syringes), which make up
the majority of sterile CDMO services with 88.9%
of market share. The sterile parenteral manufacturing sub-segment is expected to reach a market size of $6.5
billion by the end of 2016.3
In this exclusive Drug Development
& Delivery report, syringe developers and contract manufacturers
discuss how they are overcoming the challenges discussed above
and provide a look at some advancements in prefilled syringe technology.
Althea: Keeping Up With the Increased
Preference for Prefilled Syringes
During the last few years
there has been tremendous growth in sales and units of prefilled syringe versus
other injectable dosage forms. Althea prepared for this favorable market
condition by investing in a new syringe line, which became commercially
approved last year. “Our capacity utilization has increased substantially over
the past year and we have seen a marked increase in the number of
biosimilar/biobetter-based drug programs,” says Don Paul Kovarcik, Technical
Marketing Specialist, Althea. “We anticipate this trend to continue as more
branded drugs go off patent.”
Initially in the biologics
segment, vials were the gold standard. After conducting trials, the developer
would switch to prefilled syringes just before commercial launch, explains Mr. Kovarcik.
In cases where clients use alternative primary container systems, Althea works
with them to ensure they are compatible with automated filling systems.
Recently, however, many developers
have decided to simply start out using prefilled syringes. “Because of this
change, Althea has started to do a lot more prefilled syringe work much earlier
in the development process and sometimes even in the preclinical stage.”
Critical to prefilled
syringes is manufacturing high-quality product the first time. Manufacturing
success is dependent on a robust and reproducible process. To this end, Althea
has been advocating for its pharmaceutical partners to bring forward their
prefilled syringe programs in the earlier stages of development. “That way we
can identify any gaps in the production processes, which allows us sufficient time
to work through any issues prior to clinical studies and commercial launch,”
says Mr. Kovarcik.
Aptar Stelmi: Elastomeric Closure
Systems for Sensitive Injectables
Aptar Stelmi designs and manufactures
elastomeric closures: stoppers for vials, and prefilled syringe and cartridge
components such as plungers, needle shields, and tip caps for all parenteral applications.
The most recent addition to its product portfolio is the PremiumCoat™ coated
serum stopper designed for the protection of sensitive and high-value drugs, including
biopharmaceuticals.
Based on an approved,
pure, state-of-the-art formulation, the surface of the elastomer is coated
during manufacturing with an ETFE film. This coating acts as a barrier to many
of the extractables and leachables that can be released from the elastomer. As
a result, compatibility of the drug and the closure is improved. The first
design released in 2015 was the 20-mm coated stopper, and a 13-mm coated
stopper will soon be available.
Catalent Pharma Solutions: Helping
Clients Comply With cGMPs for Devices
A notable trend in the market
for sterile injectables has been toward self-injection or autoinjector devices,
which have become increasingly popular over the past few years as a means of
improving patient compliance and helping prevent needlestick injuries. Catalent
has actively supported customers in this market segment by implementing the necessary
steps to fully comply with Current Good Manufacturing Practice regulations for
devices [21 CFR 820 (cGMP)] from a quality and regulatory assurance viewpoint.
“These regulations require
a focused approach, with design reviews performed across the different parties
involved: the assembly site, the final customer, primary component supplier,
autoinjector parts supplier, and the machine manufacturer,” says Wim Blendeman,
Director New Product Introduction, Advanced Delivery Technologies at Catalent.
“These reviews are important to determine the Critical Quality Attributes
(CQAs), Critical Process Parameters (CPPs), and to put final design controls in
place in order to supply the final product reliably.”
The majority of the
investment in a typical project is made prior to starting the assembly process
and the design is checked and verified prior to starting clinical assembly.
Using information gained through the executed process, In-Process-Controls (IPCs),
Acceptable Quality Limits (AQLs), Process Control Limits (PCLs), and process
reviews need to be implemented and checked for effectiveness. These data must
also be supported by a risk assessment and facilitate the drafting of a User
Requirement Specification (URS) for a fully automated assembly line. “Due to
the precise and unique nature of the autoinjector market, equipment is, in most
cases, specifically designed to support each type of autoinjector,” says Mr.
Blendeman.
Credence MedSystems: Addressing the
Need for Innovation in Reconstitution Safety Devices
The growth of biologic parenterals
in the commercial and pipeline portfolios of drug manufacturers has been well documented.
These biologics are often formulated as powders, in lyophilized or spray-dried
form, when unstable in solution. Additionally, there are an increasing number
of applications requiring separation of two liquid components during storage.
Because of this, the number of drugs that require reconstitution or mixing at the
point of injection has increased.
The conventional approach
to reconstitution includes multiple vials, syringes, needles, and/or vial access
components, and an arduous mixing and administration process that contribute to
inefficient workflow, dosage errors, wasted drug product, and needlestick
exposure, explains John A. Merhige, Chief Commercial Officer, Credence
MedSystems. The industry has seen attempts to improve upon this approach with
vial mixing devices and multi-chamber syringes and cartridges.
“While the dual-chamber offerings
that are available or in development have been evolving, there remain
limitations with regards to efficient manufacturability, supply chain availability,
cost, usability, and safety that have placed barriers on adoption,” he says.
“With the delivery of healthcare moving from formal medical settings to the
home, and medications increasingly being administered by self-injectors, the
industry is in need of an injection system that allows those complex biologics
requiring point-of-care mixing to be injected easily and safely by less
experienced users.” To address this market need, Credence MedSystems has
developed and recently introduced its Companion Dual Chamber Reconstitution
Safety Syringe technology. “The Companion Dual Chamber shares the Innovation
Without Change design philosophy that is seen across Credence’s other safety
syringe systems, maximizing the usability and safety of the device while
minimizing the change from existing primary package components and supply chain
dynamics,” says Mr. Merhige.
The Companion Dual Chamber
simplifies the task of mixing two separated components into a single step. The
user advances the plunger rod as in a conventional injection, creating a newly
formed center channel through the standard stopper, and allowing the contents
of the rear chamber to pass into the front chamber where they are combined together
for mixing.
Beyond the simplification
of the mixing process, the Companion Dual Chamber provides important safety and
usability features. A pre-attached needle reduces yet another user step, but
also provides the key to an integrated passive safety system; the user simply
completes the injection (marked by an end-of-dose click) and then the needle
automatically disappears through the stoppers and into the plunger rod and
syringe barrel. The syringe cannot be reused and is now rendered safe for disposal.
Existing approaches to
dual chamber devices all use some combination of customized primary package
components: bespoke glass barrels with external or internal bypasses, stoppers
with specialized internal channels or wiper blades, etc. “These customized
components drive high costs, long lead times, captive supply chains, and the
potential for product failure and complaints stemming from a dependency on
primary package components that do not have a proven history in the field,”
says Mr. Merhige.
The Companion Dual Chamber
uses a standard, uniform diameter glass barrel (syringe or cartridge), standard
stoppers, and standard needle shields from well-known component suppliers.
Additionally, the Dual Chamber is glue-free, eliminating any risk of
interaction between glue and the drug product. “The combination of single-step
mixing, end-of-dose cues, passive needlestick safety, and reuse prevention
makes the Companion uniquely suited to enable a broader utilization of
point-of-use mixing devices in the home and healthcare provider markets,” he
says.
Enable Injections—Wearable Devices Make
Biologic Self-Administration Possible
Recent discussion in the
industry has centered on reducing overall healthcare costs by eliminating waste
associated with excess drug that is thrown away. For example, many biologic
drugs must be infused intravenously by a healthcare professional, typically at
a hospital. Healthcare costs could be significantly reduced, compliance
increased, and patient convenience vastly improved if patients could safely and
easily self-administer such drugs subcutaneously at home without the aid of a
healthcare professional, believes Mike Hooven, CEO and President of Enable
Injections.
To that end, Enable
Injections is developing a new class of wearable on-body drug delivery devices capable
of delivering higher volumes and viscosities with minimal discomfort.
The new generation of
wearable injectors feature improvements in construction materials, injections process,
and safety features, meant to overcome the challenges of delivering
large-molecule and high-volume biologics. For example, Enable Injections’
on-body delivery system (OBDS) is designed with a proprietary S.E.T.
(sequential elastomeric toroid) mechanical drive system. The force required to
deliver the drug does not change with the volume, and the needle size is the smallest
available, typically 31g.
“Advancements with
wearable injectors offer the opportunity to revolutionize biological therapy treatments,
especially those treating chronic conditions that struggle to attain positive
clinical outcomes due to patient adherence,” says Mr. Hooven.
While the Enable OBDS is
not yet approved or commercialized, independently conducted User Preference
studies demonstrate a high acceptance of the technology by patients and
caregivers, says Mr. Hooven. “Obtaining this information provides confidence
that development of larger volume biologics for in-home use will not be an impediment
to product uptake and acceptability.”
Gerresheimer Medical Systems:
Customized Solutions for Biotech Drugs
The specific requirements
of biologics development and production, the obligation to better understand the
final product, as well as the latest revision of the FDA Combination Product
Guidance have resulted in the more complex qualification of prefillable
syringes as the container closure system for new products, says Claudia
Petersen, Global Director Business Development Medical Systems, Business Development,
Gerresheimer Medical Systems. To address these trends, she believes close and
early interaction in the product development cycle between the packaging and/or
formulation development departments and the supplier is key to increasing patient
compliance.
To date, most
development-stage and marketed biopharmaceuticals are either monoclonal
antibodies or recombinant proteins, each with specific
requirements/sensitivities, and need to be administered by injection.
“Protein-based drug products have complex requirements that demand customized
prefilled syringe solutions,” she says.
Custom drug delivery
devices with prefilled syringes are a must in the parenteral market because of
the vast number of parenteral drugs that exist. That’s why Gerresheimer offers a
comprehensive portfolio of high-quality products in glass and cyclical olefin
polymers (COP), and adapts the syringe system to the customer’s individual requirements
profile.
“Gerresheimer is one of a
few companies in the world to offer its customers both glass and COP syringes,”
says Bernd Zeiss, Medical Systems, Technical Support Manager at Gerresheimer.
COP’s barrier properties effectively protect the content of the syringe. COP is
also transparent, which means that COP syringes are similar in appearance to glass
syringes. This transparency makes it easy to visually check the content for
clouding, particulate, and other defects. COP syringes can be used as a primary
packaging for biotechnologically derived drugs.
“These are some of the
most expensive drugs on the market and highly susceptible to external influences.
They are manufactured in high-tech processes and involve complex development
and production methods,” says Mr. Zeiss. “The very precise injection molding
process permits more exact tolerances than the free-forming process used for
glass syringes. Exact geometries are very important if the syringe is destined
for use in an autoinjector. These exact geometries also reduce the syringe’s
dead volume so that less drug residue is left inside the syringe after use.
This is a persuasive argument for manufacturers of expensive drugs.”
Nemera—A New Version of a Proven Deviceto Address Safety & Biologics
Since the early 2000s,
prefilled syringes have gained popularity due to their ease of use, improved
user safety, and the reduction of potential dosage errors. Self-administration,
at-home administration, and the rise of biologics are the main drivers of this growth.
Indeed, needlestick injuries remain a global concern with more than 3 million
exposures to blood every year, according to the World Health Organization. In
order to overcome those problems, regulation/recommendations have been
established to improve users’ conditions. As a consequence, devices such as
safety devices for prefilled syringe or autoinjectors have emerged.
While 1-ml prefilled
syringes are the common primary container, over the last years—with the rise of
biologic drugs—larger volume containers (2.25 ml) have emerged. Those biologics
have raised new challenges. “Indeed, on one hand, biologics are adding
complexity to the parenteral segment due to the nature of the drug (more
viscous and with larger filling volume), while on the other hand biologics are
targeting patients suffering from chronic diseases who have to self-inject,”
says Adrien Tisserand, Global Category Manager at Nemera.
In response, Nemera has developed
a 2.25-ml version of Safe’n’Sound®, an open, adaptable, and customizable
platform of add-on passive safety devices for prefilled syringes to help
prevent needlestick injuries. As a passive safety device, the safety feature
activates automatically at the end of the injection, easing the use.
User interface has been integrated
from the beginning in the design and development of the device, integrating
many ergonomic features: a large thumb pad surface to smooth the injection;
large built-in finger flange to facilitate handling; a round shape for more
comfortable handling; and a spring located at the syringe flange position to
provide good visibility of the tip of the syringe and enable inspection of the
drug, even with low-filling volume drugs. An optional add-on ergonomic extended
finger flange has also been developed to improve the handling, gripping, and
comfort for the user.
Safe’n’Sound has been
designed to give flexibility to the laboratories being an open and customizable
platform. Indeed, Safe’n’Sound is compatible with syringes of different filling
volume (1 ml and 2.25 ml), flange type, and suppliers. “The device provides
pharmaceutical companies flexibility on their dosage formulation, and an
innovative safety device solution to equip small- and large-volume drugs while
responding to patients’ needs in terms of ease of use and safety,” says Mr.
Tisserand. “Moreover, Safe’n’Sound is a patented, 510(k) cleared product, which
can be sold worldwide.”
Noble: Providing a Positive Patient
Onboarding Experience
The demand for prefilled
syringes continues to grow as more patients are being required to
self-administer medications, such as the increasing number of biologics and
biosimilars entering the market. As these products continue to augment and
launch into new therapeutic sectors, training and education will remain a
critical success factor that will determine a patient’s ability to safely and effectively
use prefilled syringes and adhere to therapy, explains Paul Sullivan, Associate
Director of Business Development at Noble.
Noble is a full-service,
patient-centered product development and manufacturing company that specializes
in onboarding and device training. Noble works closely with pharmaceutical and
biotechnology companies to develop educational and training solutions designed
to provide positive patient onboarding experiences, reduce errors, and improve
patient outcomes.
“There are psychological
factors that self-injection patients face, such as anxiety and confidence,”
says Mr. Sullivan. “Over the past decade, advancements in the industry have given
us a better understanding of patient adherence and the benefits of training and
education. The traditional patient educational materials have proven to be ineffective,
as studies reveal 78% of the patient population lacks proficient health
literacy4, resulting in treatment barriers for prefilled syringe
users.”
Mr. Sullivan adds that
training devices have been shown to be effective for improving patient outcomes
and adherence.
Findings also reveal
patients who use a training device are more compliant.5 Novel
training technologies like simulation needles help promote positive onboarding experiences
and empower patients to lead healthier lives.
“In the modern era of
patient-centric care, products that are able to provide superior onboarding and
patient experiences will be well positioned to reduce patient errors, while
improving patient satisfaction and outcomes,” he says.
REVOX: Sterilization Can Mean the Difference Between Success & Failure
Biologics and more complex
delivery devices are sensitive to the high temperatures associated with traditional
sterilization processes. The REVOX vaporized peracetic acid (VPA) sterilization
process is conducted at room temperature (21°C), allowing full sterilization of
the device without affecting the drug.
“Sophisticated delivery
systems like combination devices require greater simplicity for the patient and
the manufacturing process, which in turn requires the integration of diverse components
with variable suitability to standard sterilization processes,” explains Mason
Schwartz, Operations Manager and Co-inventor of REVOX. “High temperature sterilization
methods often necessitate separation of components and assembly either
post-manufacturing or with the patient. With more than 100 materials tested for
compatibility with the REVOX VPA process, the product can be fully assembled
presterilization.”
Elevated temperatures in
the sterilization process may affect the medication itself. And “surface sterilization”
with lower temperature methods is often more challenging than the term implies,
he says. “With the goal being sterilization of every component of the device
while not touching the drug, the method needs to have the capability of
penetrating mated surfaces, such as the threads on a plunger-to-stem assembly,
while providing variable controls to limit the penetration to just short of
reaching the drug itself.”
Add to this the issues
such as strict regulatory requirements, recalled prefilled syringes,
manufacturing complexity, and the cost associated with prefilled syringes. “All
of this demonstrates the obvious preference and potential advantages, from
various standpoints, to have a combined, single device for medication
delivery,” says Mr. Schwartz. “If vial/syringe packaging was ‘good enough,’
manufacturers wouldn’t be challenging that status quo with the costs and risks associated
with prefilled syringes. The sterilization method used on prefilled syringes
can be the difference between success and failure.”
From a cost standpoint,
depending on the standing infrastructure of a manufacturer, contracted
sterilization is the standard sterilization process. REVOX enables on site,
in-line sterilization that can significantly reduce per unit costs associated
with sterilization. Sometimes cost savings
aren’t enough to make a convincing argument. Mr. Schwartz recalls one client that
wanted to launch its product as a prefilled syringe. However, project timeline
pressures were intense. “We demonstrated the feasibility of REVOX VPA
sterilization of the prefilled syringe, but the client didn’t want to trade off
an on-time launch with potential delays associated with a novel sterilization
method of a prefilled syringe.”
Another client, however,
saw the “writing on the wall” in terms of the ever-lowering Ethylene Oxide
(EtO) residual standards. As the residual limits are lowered, the WIP (work in process)
time and volumes increase with the need for greater EtO post-processing
aeration times. “We continue to work with this client to demonstrate the
efficacy and economic benefits of transitioning from EtO to in-house VPA sterilization.”
Mr. Schwartz continues:
“We are seeing a tremendous increase in the need for sterilization of advanced combination
and prefilled syringes. We’ve seen commercialization plans compromised with
vial versus prefilled syringe packaging simply because of traditional
sterilization constraints.”
SCHOTT Pharmaceutical Systems: Polymer
Syringe Eases Viscous Drug Delivery
With regards to syringe
manufacturing, significant achievements have been made in recent years. This
leads to an overall reduction of cosmetic defects (which otherwise could have
an impact on filling operations) and enhanced mechanical strength of the
syringe. For example, syringe barrels can be produced with tighter dimensions, which
ensures a better fit with safety devices; tungsten residues and siliconization
can be controlled in a better way, the latter by diving nozzle technology,
resulting in a uniform distribution of the silicon oil inside the barrel; and
highly automated handling of the syringe during production helps to further
reduce defects.
“Looking ahead, patient
comfort and safety will become even more prevalent,” says Anil Busimi, Director
Strategic Marketing and Innovation, SCHOTT Pharmaceutical Systems. “A very important
point is drug container interaction and the determination of extractables and
leacheables (E&L).
To address this, SCHOTT introduced
a new prefillable polymer syringe, designed to improve the safety and stability
of sensitive drugs. The product, SCHOTT TopPac® SD, offers new
features for a reduced E&L profile, such as an inert COC (cyclic olefin copolymer)
barrel that releases no ions or heavy metals; cross-linked silicone for barrel
lubrication that reduces the amount of subvisible particles and still ensures
optimal functionality; and the syringes are sterilized with an ETO (Ethylene
Oxide) method, rather than irradiation.
To address the topic of
patient comfort, a new syringe (TopPac SD) was designed with one of SCHOTT’s clients
to make the application of hyaluronic acid safer and more comfortable. “Given
that hyaluronic acid is highly viscous, doctors need to apply a great deal of
injection force when they use conventional luer lock syringes to give the
injections,” explains Mr. Busimi. “It is not uncommon for that to cause
patients to feel pain. In extreme cases, the high pressure can even disconnect
the needle hub from the syringe and, in a worst-case scenario, lead to breakage
of the luer lock adapter. For that reason, highly viscous drugs (HVD) require
packaging that allows a consistent gliding/injection force. The newly designed
syringe comprises a smaller inner diameter, as well as optimized
siliconization. This ensures that the plunger slides evenly with low injection
force and that the medication can be administered in precise dosages. The
syringe also features an integrated luer lock that prevents leakage, breakage,
and needle pop off.”
SCHOTT also added new
closure systems for its prefilled syringe portfolio. “These rigid caps ensure
the integrity of the container, yet can easily be opened by healthcare professionals
or patients,” he says. “The closure adds a great deal of flexibility to our customers’
supply chain, and speeds up time to market for new or already existing drug
products.”
Vetter: Tackling the Challenges ofPackage Design & Material
Large (bio-)pharmaceutical
companies often focus their efforts on core competencies, such as late-phase development
and drug marketing. To improve their efficiency in these areas, they are making
efforts to reduce and simplify their network of different service providers. “Whenever
possible, they purchase a solution that equates to ‘one-stop-shopping,’” says
Bernd Stauss, Senior Vice President Pharmaceutical Production/Engineering,
Vetter Pharma-Fertigung GmbH & Co. KG.
But it’s not just single
sourcing in partners that matters to pharma. An all-in-one concept is also
appealing with regard to prefilled syringe technology and the issue of lyophilization.
Dual-chamber systems offer advantages in this sector. The Vetter Lyo-Ject®
dual-chamber syringe is designed for sensitive drugs that will not degrade in a
lyophilized state. The actual active ingredient is lyophilized in one chamber,
while the other chamber of the syringe contains a solvent that is mixed with
the active substance immediately before application.
“This all-in-one concept
enables a long shelf life as well as easy handling. This also means higher
yields of your active product ingredient and precision in dosing,” says Mr.
Stauss.
In addition to package
design, packaging material plays an important role. For instance, Mr. Stauss
says it can be a challenge to determine the right amount of silicone that will
enable the correct movement of the plunger rod while avoiding any form of
interaction between the silicone and the drug substance.
Consider this real-life
example. High-value products are often based on very complex compounds. This means
that these compounds demand a high degree of accuracy on the filling line. As a
manufacturer, Vetter has to deal with the increased sensitivity to
manufacturing processes and environmental conditions. One highly sensitive API
required very small fill volume in a syringe device. “Small filling volumes
create an increased demand on all production areas, including process design, technical
equipment, and packaging material,” he explains. As such, packaging material
and processes needed to be adapted to meet the requirements of this product.
“Reaching the right amount
and correct application technique of the silicone coating the syringe is but
one example of the challenges we face in fill/finish projects like this one,”
says Mr. Stauss. “Comprehensive project management is also needed to handle
such a project successfully, taking into consideration the needs of both the
product and the customer.”
West: Delivering Delivery Differentiators
for Biologics & Combination Products
Last year saw the first
FDA-approved biosimilar. Advanced drugs, like biologics and biosimilars, require
sophisticated packaging and drug delivery systems, and the market has responded
with offerings that address this new need. In the case of biosimilars, with
many companies competing for the same therapy, the mechanism of administration
can be a key differentiator. West’s contribution to this evolution has included
Daikyo Crystal Zenith® cyclic olefin polymer (COP), which is used to
produce a technologically advanced COP containment and delivery system. Crystal
Zenith is proven to complement biopharmaceuticals and other complex, high-value
medicinal products because it addresses the need for clear, biocompatible material
that helps mitigate the chemical interaction and breakage risks inherent in
glass, says Mike Schaefers, Vice President, Global Product Management and
Marketing Operations, West Pharmaceutical Services, Inc.
“For injectable
biosimilars currently in the pipeline, it will be important to examine drug
delivery options that can improve the patient experience while ensuring, when
possible, a delivery format with which patients are familiar and comfortable,”
says Mr. Schaefers.
“Together, device and drug
manufacturers can work seamlessly as partners to provide innovative solutions
that help mitigate risk, encourage patient adherence, and enhance value.”
Focusing on enhancing
quality from early development through commercialization, West adopted Quality
by Design (QbD) concepts in the design and manufacturing of packaging
components. QbD delivers an improved, data-driven output, providing superior
product and process understanding that minimizes risk, emphasizes
patient-critical quality requirements, and enhances drug product effectiveness.
For example, West’s NovaPure® plungers incorporate functional
performance parameters like gliding and breakloose forces, which are very
important to ensure consistent injectable drug administration when syringes are
used in combination with an injection device.
And when it comes to the popularity
of combination products, drug manufacturers are more heavily relying on
companies like West to offer insight into the regulatory process related to
components. “Our expertise around how drugs may interact with the delivery
systems can help to avoid regulatory delays, increase safety and expedite the
process of getting combination products to market,” says Mr. Schaefers.
Additionally, combination products
have also brought to the forefront the importance of flexible manufacturing,
which enables drug companies to quickly transition fill lines from vial format
to cartridge to prefilled syringes, depending on the needs of the injectable medicine.
Finally, the popularity of
combination products has raised the bar in terms of developing drug containment
and delivery systems that are safer and enhance the patient experience. “West
strives to manufacture packaging and delivery systems that are easy-to-use,
minimize discomfort, and work in a way that is compatible with patients’
lifestyles, as they need to easily assimilate these devices into their daily
routines.”
References
1. The Future of Alliances
and Partnerships in the Pre-Filled Syringes Market to 2020, Smithers Rapra, http://www.smithersrapra.com/market-reports/medical/the-futureof-
alliances-and-partnerships-in-the-pr,
accessed April 13, 2016.
2. Global Prefilled
Syringes Market Size, Share, Development, Growth and Demand Forecast to 2020 -
Industry Insights by Type (Glass Prefilled Syringe, Plastic Prefilled Syringe),
Reportbuyer, http://www.prnewswire.com/news-releases/global-prefilledsyringes-market-size-share-development-growth-and-demandforecast-to-2020--industry-insights-by-type-glass-prefilled-syringeplastic-prefilled-syringe-300217393.html,
accessed April 13, 2016.
3. Bolstering Capabilities
for Parneteral Drug Development and Manufacturing, AAI Pharma, http://www.niceinsight.com/Userfiles/Articles/PDFs/PA_1015_AAIPharma.pdf,
accessed on April 13, 2016.
4. U.S. Department of
Health and Human Services. (n.d.). Health Literacy - Fact Sheet: Health Literacy
Basics. Retrieved from http://health.gov/communication/literacy/quickguide/factsbasic.htm.
5. The link between device
training and patient compliance. Noble, Poster session presented at PDA,
Universe of Prefilled Syringes
2015, Vienna, Austria.