the growth & benefits of pre-filled syringes: what clinical … · 2019-10-30 · market a shot...

The Growth & Benefits of Pre-Filled Syringes: What Clinical Supplies Teams can Learn about Precision Assembly & Labeling 27 Questions to Ask a Supply Chain Partner (see page 15)

October 2016

The Growth & Benefits of Pre-Filled Syringes: What Clinical Teams can Learn about Precision Assembly & Labeling

of 21

Table of Contents

3 Introduction

5 Robust Growth Rate of Biologics

6 Facts about Pre-filled Syringes

7 What’s Driving Demand for Prefilled Syringes

9 Benefits of Pre-Filled Syringes

11 Clinical Supply Planning for Pre-filled Syringes

13 Considerations for Manufacturing Strategies

15 27 Questions to Ask a Supply Chain Partner

17 How Fisher Clinical Services Approaches Assembly and Labeling

20 More about Fisher Clinical Services

21 References


of 21

Introduction

After decades of domination by small-molecule drugs, one could say that the pharmaceutical industry is increasingly thinking large. In a telling indication of the transformation underway across the industry, pharma companies are directing more of their resources and research efforts to large-molecule biological drugs, most of which are injectable.

More than 60% of drugs currently in clinical development are

biologics for parenteral administration (1, 2). The small-to-large molecule shift is giving the pre-filled syringe

market a shot in the arm, making it one of the fastest growing segments of the injectable drug delivery device market. Pre-filled syringes have become an increasingly important option in the packaging and delivery of parenteral drug products. The global market for pre-filled syringes is projected to reach $5 billion in 2019 from $2 billion in 2012 (3).

The robust growth reflects the compelling benefits of pre-filled

syringes for drug manufacturers, healthcare providers and patients compared to conventional vial and ampule packaging. Biologics have been a resounding success for the pharmaceutical industry, having made long-term treatment advances possible for many serious diseases. In addition to being the preferred means of delivering drugs in many targeted therapeutic areas, such as oncology and immunology, pre-filled syringes can also reduce overfill waste and thus manufacturing costs compared to syringe and vial formats.

Other factors are also contributing to the expansion of the pre-

filled syringe market: Patent expiries for biologics are creating a new & competitive market for biosimilars, a new class of drugs expected to increase the availability of affordable medicines. Changing medical practices include a rise in self-administration of drugs to contain healthcare costs and immunizations taking place outside traditional medical settings. A swelling population of elderly people is living longer with chronic diseases, such as diabetes and rheumatoid arthritis, which require frequent dosing (4, 5).

Finally, there is the substantial impact of technological

innovations that have transformed the assembly and labeling of pre-filled syringes. With trials of biological drugs climbing in volume, size and complexity, manual assembly and labeling of pre-filled syringes for studies – once standard practices – are no longer the only viable options. Using the latest automated equipment, tens of thousands of pre-filled syringes of every size and shape can be assembled and

More than 60% of drugs in clinical development are biologics for parenteral administration (1, 2).


of 21

labeled with precision and speed. Afterward, new shipping options ensure that pre-filled syringes reach investigator sites across the globe in pristine condition.

As with all clinical trials, studies using pre-filled syringes require

well thought out clinical supply plans and, increasingly, an innovative supply chain partner capable of offering flexibility alongside precision automation and global processes.

This Whitepaper examines the growth of pre-filled syringes, the

factors contributing to this growth, and the key role technological advances in syringe assembly and labeling are playing in this expanding market.


of 21

Robust Growth Rate of Biologics

There is mounting evidence that the pharmaceutical industry’s

pursuit of large molecule biologic drugs will fuel the pre-filled syringe market for years to come.

Regulatory approvals for biotechnology drugs nearly doubled in

the last decade, compared to the 1990s, according to a study by the Tufts Centerfor the Study of Drug Development (CSDD). During the 2000-2009 period, 65 biopharmaceutical products received marketing approval from the U.S. Food and Drug Administration (FDA), up from 39 in the 1990s and 13 in the 1980s.

In 1989, a mere 13 biotechnology products were commercially

available; in 2012, the number was up to 210. By the next year, pre-filled syringes accounted for a quarter of the total injectable drug delivery systems market, while 35 of the 100 top-selling drugs were being administered by injection (6, 7, 8, 9).

Meanwhile, the gap between patent filings for biologics and small

molecules has been widening. By 2009, biologics accounted for 60% of the patents filed by the top 10 pharma companies, according to a report by law firm Withers & Rogers in the United Kingdom.

Another analysis concluded that biologics may have better

prospects than small molecules for advancing from the laboratory through the clinic to the marketplace. More than 25% of large molecules in Phase II between 2006 and 2010 reached the market compared to about 10% of small molecules, according to KMR Group, a biopharma industry consultancy (7).

Explanations for the differences are as yet unclear, but may be

because large molecule development is more targeted and, given therapeutic areas and functions -- e.g. immunologics and replacement therapies – safety issues may be less prevalent, Dr. Joseph DiMasi of Tufts CSDD told Genetic Engineering & Biotechnology News in 2012 (2).

Taken altogether, the evidence points to robust growth for the

pre-filled syringe market, projected to grow at a compound annual growth rate (CAGR) of 13.3% to USD $4.98 billion in 2019 from $2.09 billion in 2012 (3)

35 of the 100 top-selling drugs administered by injection


of 21

Facts about Prefilled Syringes

A pre-filled syringe is a single-use, disposable drug delivery system

filled with a measured dose of drug or vaccine. Pre-filled syringes have been available for more than two

decades. They consist of pre-filled syringe cartridges containing drug or vaccine designed to fit into specialized syringes. Pre-filled syringes are used in place of standard syringes, which healthcare practitioners must fill manually before administering a dose of drug or vaccine to a patient.

Assembly – Though a simple concept, pre-filled syringes are anything but simple to assemble. Each pre-filled syringe has multiple components -- including a cartridge or barrel, piston, tip cap, plunger rod, lubricant, needle, needle shield cover, lock adapter, tamper evident, and finger grip extender or back stop. Precise assembly is critical for safe, effective administration (3, 5, 10, 11).

Dual purpose – Pre-filled syringes serve two purposes. The primary packaging role assures that there is no adverse effect on the identity, sterility, strength, quality, purity or potency of the drug/vaccine during its shelf life. The secondary packaging role is that of a delivery system to ensure that the right dose of drug/vaccine is administered to a patient (10).

Products – New categories of injectable drugs are being delivered via pre-filled syringes today, including anti-infectives and vaccines, as well as treatments for diseases such as cancer, rheumatoid arthritis, multiple sclerosis, psoriasis and Crohn’s disease (4, 5).

Similar delivery systems – Pre-filled syringes are single-use delivery tools, but similar multi-use devices are also increasing in use. The leading example: Insulin pens, which are gaining popularity as the global incidence of type 2 diabetes climbs.

Glass v. Plastic – Pre-filled syringes can be made of either glass or plastic, each of which has advantages and disadvantages.

Though a simple concept, pre-filled syringes are anything but simple to assemble.


of 21

What’s Driving Demand for Prefilled Syringes

Until recently, most injectable drugs were supplied in sterile vials

or ampoules. That’s changing, however, as sponsors increasingly opt to use pre-filled syringes in clinical trials of biological drugs.

Here’s why: • Success & Growth of Biologics. Biological drugs have been

reshaping the practice of medicine and treatment of chronic and acute conditions. They’ve also been a resounding success for the pharmaceutical industry, credited with making leaps forward possible in the long-term treatment of many diseases, including cancers, diabetes, kidney failure, multiple sclerosis and rheumatoid arthritis. Today, 6 out of 10 drugs in clinical development are biologicals targeted for parenteral administration. This is because most biologics, including vaccines, monoclonal antibodies and anticoagulants, are large molecules that must be administered parentally to achieve the desired therapeutic effect (1, 12).

• Advent of the Biosimilars Era. A number of best-selling

biological drugs that generate more than $80 million in annual global sales will lose patent protection through 2015, creating a biosimilars market that is poised for explosive growth in the next decade. So large is the biosimilars market – projected to exceed $26 billion by 2022 – that it is spawning a fierce development race involving generic manufacturers, emerging market firms, Big Pharma, biotechnology companies and even companies with no drug experience whatsoever. Healthcare systems faced with aging populations, a rising incidence of disease, and strained budgets are looking to biosimilars for cost savings (13).

• Immunization in Non-Medical Settings. There is a growing

trend of vaccinations being administered outside traditional medical settings – in schools, pharmacies, retail outlets and even airport kiosks – by non-physicians. One example is the administration of flu vaccines by pharmacists at leading U.S. drugstore chains. Dubbed the “retailization of immunization” by one industry insider, this trend is also driving growth in the pre-filled syringe market, since pre-filled syringes are simple, efficient and convenient to use under such circumstances. Pre-filled syringes are also ideal for emergency use in the event of an influenza pandemic, for example (5).

• Rise in Chronic Diseases. Chronic diseases have been on the

rise for decades and are the leading cause of death and disabilities in the United States. About 133 million Americans

Growing trend of vaccinations being administered outside traditional medical settings – the “retailization of immunization”


of 21

-- nearly 1 in 2 adults -- live with at least one chronic illness. In the U.S., 75% of healthcare dollars are spent to treat chronic diseases. An increasing number of chronic diseases are treated with injectable drugs, the best example of which is type 2 diabetes, recognized as a global epidemic by the World Health Organization (WHO) (14, 15).

• Graying Global Population. Between 2000 and 2050, the

proportion of the world’s population over age 60 will double to 22% from about 11%, while the number of people aged 60 years and over is expected to increase to 2 billion from 605 million during the same period. Many are living with chronic illnesses that require frequent parenteral dosing. Poor vision and a lack of manual dexterity make it difficult for many to handle conventional vials and syringes (16).

• Increasing Self-Administration. Self-administration makes it

possible to take healthcare treatment out of the hospital and into the home. The growing trend toward self-administration of injectable drugs for chronic diseases such as diabetes, rheumatoid arthritis and multiple sclerosis is expected to help control burgeoning healthcare costs and impose more responsibility on patients for their health (4, 5).

• Branding Advantages. Pre-filled syringes are helping pharma

companies with brand differentiation and life cycle management. Companies typically launch new products in standard vial-and-syringe format, then switch to pre-filled syringes for second-generation products. This allows them to differentiate their product from competitors based on ease of use (5).

• Technological Advances. Innovations in technology have been

game changers in the use of pre-filled syringes for large global trials of biological drugs. In the past, sponsors had to use conventional vials and syringes in such trials, since assembly and labeling of pre-filled syringes was strictly a manual process. Today, however, automated equipment has made it possible to assemble and label tens of thousands of pre-filled syringes rapidly using the highest quality standards. In addition, special shipping options that prevent stopper movement during transport can ensure that pre-filled syringes reach clinical sites safely.


of 21

Benefits of Pre-Filled Syringes

Pre-filled syringes offer compelling benefits for biopharmaceutical

companies and end users, including both patients and healthcare professionals.

Benefits for Biopharmaceutical Companies • Material & cost savings: Pre-filled syringes usually offer

manufacturers lower overall cost-per-dosage-unit as compared with syringes and vial formats because they reduce overfill to 4-5%. Conventional syringes and vials include as much as 20-30% overfill to account for potential waste in administering the product. Reducing overfill is an important consideration when manufacturing and product costs are high and bulk manufacturing capacity is low, as is often the case with biologics under development. Some biologicals are valued at as much as $2,000 per dose.

• Affordability: Standard syringes, which feature cylindrical glass barrels and tightly fitting glass rods, are more expensive to manufacture than plastic-based, pre-filled cartridges and corresponding syringes. Plastic pre-filled syringes are also less likely to crack or break in comparison to their standard glass counterparts.

• Accuracy & reproducibility: Prefilled syringes assure that

patients receive accurate dosages. Using standard syringes, it’s possible to under- or over-fill the barrel, which could impact the efficacy of the treatment and the results of a clinical trial.

• Ease of handling: Prefilled syringes are easier to handle, store

and ship than vials, an important consideration given the increasing number of global clinical trials. Pre-filled syringes weigh less and take up less space than vials, so they cost less to ship and occupy less space. Space considerations are important to clinical sites, which are perennially storage-starved (3, 5, 17, 18).

Benefits for Patients • Convenience & Adherence: The ease of using a pre-filled

syringe instead of a conventional vial and syringe can reduce patient anxiety about self-administration, thus increasing patient satisfaction and treatment compliance.

• Fewer dosing errors: Pre-measured dosages can reduce

Pre-filled syringes offer lower overall cost-per-dosage-unit as compared with syringes and vial formats because they reduce overfill to 4-5%.


of 21

dosing errors, particularly for those who need to self-inject, but have no medical training, or who suffer from poor eyesight or manual dexterity (17).

Benefits for Healthcare Professionals Studies indicate that 9 out of 10 healthcare professionals prefer

pre-filled syringes to conventional needles & syringes for the following reasons:

• Time-saving & ease of administration: Pre-filled syringes save

time and allow injections to be administered more quickly in busy practices and hospitals. Instead of managing a vial and syringe, pre-filled syringes permit medical professionals to “point and shoot.”

• Safety: Pre-filled syringes equipped with Needle Safety

Devices (NSD) prevent needle stick injuries, an issue of growing concern among healthcare professionals and health and regulatory bodies around the world.

• Accurate dosing: Pre-measured and pre-filled syringes ensure

that patients receive accurate dosages and reduce medication errors.

• Sterility: Drugs/vaccines in pre-filled syringes have a shelf life

of 2-3 years and typically do not require preservatives. Once a standard syringe is filled with drug/vaccine, it remains optimally sterile for about 12 hours. There is also a low risk of microbial contamination with pre-filled syringes compared with standard syringes (17, 18).


of 21

Clinical Supply Planning for Pre-filled Syringes

With trials of biologicals climbing in volume, size and complexity

as timelines shrink, there is no substitute for developing a clinical supply plan.

The absence of a well-thought-out clinical supply plan is akin to departing on a cross-country journey in a car without directions, a map, a global positioning system (GPS), gasoline or air in the tires.

A clinical supply plan is a highly detailed, step-by-step blueprint of the activities necessary to conduct a successful clinical trial. A plan helps ensure that the clinical supply chain doesn’t unravel and endanger a multi-million dollar clinical trial — or an entire development program — of injectable biologics, which are both costly and often available in limited supply.

A clinical supply plan should be comprehensive and global in nature. It exists for the benefit of both sponsor and supply chain partner, who share the common goal of starting the trial on time and ensuring that the right drug reaches the right investigator site/patient at the right time. Importantly, a plan also helps surface issues, problems and bottlenecks with ample time to seek out solutions. Here are some points to keep in mind about developing clinical supply plans.

• Start early. Companies identify the lead candidates in their

pipelines a year or more in advance of starting clinical development. Ideally, this is when clinical supply planning should begin, including identification of a supply chain partner capable of providing precision automated assembly and labeling of pre-filled syringes.

• Work backward. Once trial start dates are selected, it’s

important to work backward to identify lead times for all necessary activities. Some examples: Shipping clinical supplies to investigator sites; obtaining necessary approvals, such as import licenses and regulatory approvals; storing clinical supplies; packaging and labeling clinical supplies; obtaining the materials necessary to package and label clinical supplies, such as the components for pre-filled syringes; producing the required supply of bulk investigational medicinal product (IMP), and so on.

• Identify potential problems. Be proactive, rather than reactive, with respect to supply challenges. Better to prepare for potential bumps in the road than wait for them to derail the supply chain. Proactively identifying potential supply issues in advance instead of reacting under pressure can prevent costly disruptions. Examples: How large will

Will the syringes require dosage labels? Will they need needle safety devices? What size and configuration will the syringes be?


of 21

production runs be? Will the syringes require dosage labels? Will they need needle safety devices? What size and configuration will the syringes be? Are there cold chain shipment issues? Are there likely to be air transit issues with respect to stopper movement? Are investigator sites likely to need additional refrigerated storage? A clinical supply chain partner can help identify and manage solutions.

• Remain flexible. Keep in mind that a supply plan isn’t a once-

and-done objective. A plan will need to be adjusted on a regular basis to reflect changing circumstances and the evolving demands of an ongoing clinical trial.


of 21

Considerations for Manufacturing Strategies

As biopharma companies turn to large-molecule biologicals, they

are increasing their reliance on outsourcing partners for help in assembling and labeling pre-filled syringes for use in global clinical trials.

Many large biopharma companies have their own dedicated automated facilities for assembling and labeling pre-filled syringes for commercial products. Even so, they may lack sufficient capacity to meet both commercial requirements and the demands of large clinical trials.

Efforts to meet both needs can lead to time-consuming bottlenecks as commercial and clinical operations compete for finite internal resources. To prevent such bottlenecks, sponsors are turning to clinical supply chain partners for assistance.

Automated v. Manual Placing tablets into blister packaging is relatively simple compared

with assembling and labeling pre-filled syringes. As little as five years ago, help from a clinical supply chain partner in assembling and labeling pre-filled syringes for a clinical trial always meant a painstakingly time-consuming manual process. This limited the use of pre-filled syringes to relatively small trials or production runs. Thankfully, times have changed, and so have the available options.

To illustrate the difference between then and now, imagine a production suite containing 10 trained operators who spend a day manually assembling and labeling pre-filled syringes. At the end of the shift day, the yield would be about 400 syringes.

Today, using precision automated equipment in that same production suite, the yield at the end of the shift day is about 13,000 syringes. This tremendous productivity increase makes it practical and cost-effective to use pre-filled syringes for studies involving thousands of subjects.

Quality Assurance: Consistency & Control Precision automation also offers quality assurance that is superior

to that of manual assembly when conducting large runs, making the use of pre-filled syringes as risk-free an experience as possible for healthcare professionals and patients.

Variations in the manual assembly of pre-filled syringes are inevitable and can affect performance. For example, an under- or over-turned plunger rod can lead to leakage that compromises syringe integrity, ruining the unit and wasting costly product.

Similarly, an imprecisely applied NSD could result in a needle stick injury, an unnerving experience even for a healthcare professional who knows the syringe was not previously used.

Automated assembly and labeling reduce risk in the process

A fully-automated compliance check uses a camera system to detect the position of the syringe at all times.


of 21

through consistency and control. Automated systems vary, but the best ones are highly precise and efficient, assembling and labeling pre-filled syringes in one fully automatic process. The systems employ a combination of customized equipment, sensors, torque control and camera systems that permit operators to maintain full control over the entire process from start to finish.

For instance, a fully-automated compliance check uses a camera system to detect the position of the syringe at all times. Sensors monitor every step of the assembly and labeling process, reading exactly how much force is being applied to a backstop or plunger, for instance, and thus eliminating the risk of under- or over-turning. Using camera checks, a labeling platform ensures that the correct patient label is affixed to the corresponding syringe.

While automated assembly and labeling of pre-filled syringes are increasingly preferred by most sponsors, manual assembly may be the most flexible and cost-effective option for small trials or production runs.

New options are now available that couple some elements of automation with manual assembly to deliver greater precision to smaller runs.

Sponsors can benefit from these many options by building flexibility into their planning and by exploring the assembly and labeling services that are most suited to their needs. Moreover, it’s important to engage a supplier that is capable of meeting both automated and manual needs.


of 21

27 Questions to Ask a Supply Chain Partner

Once a clinical supply plan is in place and there is a decision to

outsource assembly and labeling of pre-filled syringes, the next step in the process is engaging an innovative supply chain partner.

It goes without saying that all potential partners aren’t equal. Consistency, quality and a proven track record are critical requirements in choosing a supplier. Asking the right questions about a potential partner’s service offerings and experience can provide the data necessary to make an informed choice. Here are some examples:

1. What role does each member of the project team play? 2. What are their backgrounds and experience in the industry? 3. How much experience does the project team have with

automated pre-filled syringe assembly & labeling? 4. How long has automated service been available? 5. To date, how many syringes were assembled & labeled? 6. For how many clients? How many return clients? 7. In the last year, how many syringes were assembled &

labeled using the automated equipment? 8. What types of Active Pharmaceutical Ingredient? 9. Can you describe the automated assembly & labeling

process in detail? 10. At which global facilities is semi-automated and automated

service available? 11. Is there redundancy at each site in case of equipment

problems? 12. Is the process for assembly & labeling consistent across all

global facilities? 13. How is the automated equipment qualified & validated? 14. Is it possible to adopt and implement a sponsor’s quality

assurance (QA) requirements? 15. How are precision, safety & consistency guaranteed? 16. What safeguards are in place? 17. What is the rejection rate? 18. Are the automated equipment & processes capable of

accommodating all sizes, types and design of syringes and other elements, such as backstops? Both glass & plastic?

19. What are the limits of the equipment? In other words, what can’t it handle?

20. How much lead time is necessary for automated assembly & labeling?

21. Can a decision to change syringes or other parts, such as a plunger or back stop, during the course of the trial be accommodated? How quickly?

22. What special storage provisions are in place for cold-chain

11. Is there redundancy at each site in case of equipment problems? 12. Is the process for assembly & labeling consistent across all global facilities?


of 21

products? What is the capacity? 23. What kinds of back-up systems/equipment/processes are in

place? How often have you had to use them? Under what circumstances?

24. Are semi-automated services available? At which sites? What is the capacity?

25. What are the quantity recommendations for manual assembly v. semi-automated v. automated assembly of pre-filled syringes?

26. Can you describe the labeling options and process? Are assembly & labeling discrete processes?

27. What safeguards are in place to ensure that labeling is precise?

As the use of pre-filled syringes continues to grow, flexibility and

careful planning in clinical settings will benefit sponsors during development and beyond by establishing a strong foundation for building a commercial plan. Meanwhile, suppliers must adapt to the changing needs of sponsors by continuously innovating new solutions.


of 21

How Fisher Clinical Services Approaches Assembly and Labeling

More than 5 years ago, a customer approached Fisher Clinical

Services with a proposition: Was the vendor willing to build a pre-filled syringe assembly machine in the United States for one of the firm’s drugs? The company explained that it wanted to lower risk in its supply chain by assembling and shipping the product from a U.S. location in addition to the European site already in use.

As they say, the rest is history. The automated pre-filled syringe assembly and labeling service

Fisher Clinical Services began at the request of a single forward-thinking customer grew as the pharma industry shifted its attention and resources to large-molecule biological drugs.

In the years since initiating the service, Fisher Clinical Services has assembled and labeled more than five million syringes. Campaigns have ranged from 500 to 50,000 syringes, with the largest numbering 250,000 units.

So great has been the demand for the service that Fisher Clinical Services is now offering precision pre-filled syringe assembly and labeling at all major facilities – in Allentown, PA, and Mt. Prospect, IL, USA; Horsham, UK; and Basel, Switzerland – using a consistent global process.

The semi-automated equipment is capable of assembling and labeling 20 syringes per minute versus 30 syringes per minute for fully automated machines.

The addition of semi-automated services underscores the innovation and flexibility that have become hallmarks of Fisher Clinical Services. When a global search for semi-automated equipment to purchase turned up nothing that met Fisher Clinical Services’ exacting specifications, the team at the firm’s automation and engineering Center of Excellence in Basel took on the task of designing, building, qualifying and validating the equipment in-house. The team’s latest accomplishment: A fully automated syringe assembly and labeling system that operates in 2°-8° Celsius conditions.

Other innovations include eliminating glass-to-glass and glass-to-steel contact in equipment. Glass-to-glass contact can cause syringes to crack, causing safety issues and compromising product sterility. Glass-to-steel contact can scratch syringes, a cosmetic effect that can nonetheless cause them to be rejected.

Here is additional information about Fisher Clinical Services’ fully automated pre-filled syringe assembly and labeling services:

Mitigates risk through global processes & quality. Fisher Clinical

Services offers a fully-automated, continuous process from syringe assembly to label application to electronic verification of label text. The combination of global quality processes, systems and like

Campaigns have ranged from 500 to 50,000 syringes, with the largest numbering 250,000 units.


of 21

equipment positioned at all major facilities ensures consistency and eliminates variability in syringe assembly or operational performance.

With similar processes and equipment positioned around the globe, the use of air transit and corresponding concerns about air pressure differentials impacting pre-filled syringes reject rates can be mitigated or eliminated.

To mitigate any potential for product wastage or syringe rejection, Fisher Clinical Services’ operational capabilities were designed to meet any degree of precision standards set for stopper movement. The fully automated system can detect +/-1MM stopper movement, ensuring exact trial standards and reducing the potential for wastage or syringe rejects. Additionally, the ability to assemble syringes in 2°-8° C semi-automated production environment reduces the time the product is out of temperature range and the potential for temperature excursion.

For those trials where air transit of syringes, and the corresponding air differential causing plunger movement, is of major concern, Fisher Clinical Services offers a proprietary, patented secondary packaging option: the ProSyriesSM Pre-Filled Syringe Air Transit Packaging.

Custom-designed to prevent stopper movement during flight, this packaging can help maintain sterility and thereby mitigate the risk of losing container integrity.

In addition to electronic verification of all printed text, when using Clintrak labels, OCR-OCV controls and built-in quality processes ensure 100% inspection of variable and fixed text for accuracy and legibility.

Maximizes flexibility to meet the needs of every trial & every

syringe. Fisher Clinical Services’ pre-filled syringe and labeling services were built with flexibility in mind.

Regardless of syringe shape, fill size or required packaging conditions, our systems can handle the dynamic and unique requirements of any trial, all while maintaining precision in meeting the quality standards you’ve set for stopper movement. Besides the ability to package under ambient or 2-8C, as noted above, Fisher Clinical Services also offers multiple label and blinding options. High-precision syringe labeling, with an accuracy range of +/-0.5MM, is available when dosing graduation needs to be printed on the label.

Built with flexibility in mind, Fisher Clinical Services’ syringe assembly and labeling services can meet the exacting requirements of any trial.

Safeguards patient & medical staff safety. When precision means

safety, patients will receive the exact dose they need every time. Whether it is through high-precision labeling or a high level of precision in plunger rod assembly to prevent stopper movement,


of 21

Fisher Clinical Services’ innovative and precision-controlled processes ensure that patients receive the exact dose intended.

Needle Safety Devices can also be assembled on any syringe to prevent accidental punctures of patients or medical staff.

Delivers efficiencies & eliminates costly bottlenecks. Time-

consuming and costly bottlenecks often occur as a result of attempting to manually assemble syringes onsite.

Aside from the human variability introduced into the process, clinical supplies held up waiting for manual assembly or for commercial lines to open up can impact the timely delivery of drug to sites and patients. Fisher Clinical Services’ automated equipment and processes not only deliver precision and reduce variability, but also allow for fast change-over and setup timelines that eliminate costly bottlenecks. Kit assembly takes place in the same room where syringes are assembled and labeled, for one continuous, efficient process.


of 21

More About Fisher Clinical Services

For more than 25 years, Fisher Clinical Services has exclusively

focused on serving the packaging and distribution requirements of clinical trials across the world. With exposure to multi-national trials and thousands of protocols every year across all therapeutic areas, Fisher Clinical Services has developed the industry’s best practices in clinical supply chain management. From the outset, its global project management teams and Subject Matter Experts design efficiencies into pack configurations, multi-lingual labeling and inventory controls that ultimately ensure the optimal receipt, packaging, storage and distribution of ambient and cold chain clinical trial materials to any location in the world.

Quality Assurance teams proactively ensure Standard Operating Procedures are strictly implemented and that current Good Manufacturing Practices (cGMP) are rigorously executed across all facilities. Its teams have developed a depth of expertise and understanding of the unique needs of clinical supply chain services internationally and locally. The breadth of services provided at local levels includes pooled supplies, local labeling and regulatory support. Recent highlights include continued investment in cold chain and controlled drug capability, and further expansion plans to meet clients’ needs.

Part of Thermo Fisher Scientific Inc. (NYSE: TMO), Fisher Clinical Services has a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials. It offers worldwide support for all aspects of clinical supply management including clinical supply optimization; comparator, co-medication and ancillary supply sourcing; packaging and labeling; storage and distribution; through to returns and destruction. Its 25 years of experience focused on clinical trials enables expert guidance and full logistics support for all types of clinical programs and projects.

Its parent company, Thermo Fisher Scientific, is the world leader in serving science, with revenues of $17 billion and more than 50,000 employees in 50 countries. The company mission is to enable customers to make the world healthier, cleaner and safer. It helps customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through its premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – it offers an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

Thousands of protocols every year across all therapeutic areas Contact Us www.fisherclinicalservices.com Ahmedabad, India Tel: +91 27 1766 2200 Suzhou, China Tel: +86 512 6733 2080 Beijing, China Tel: +86 108 947 2071 Singapore Tel: +65 6808 0700 Tokyo, Japan Tel: +81 36 457 0250 Basel, Switzerland Tel: +41 61 485 2300 Weil am Rhein, Germany Tel: +41 61 485 2300 Horsham, UK Tel: +44 1403 2127 00 Moscow, Russia Tel: +74 95 505 6564 Pretoria, South Africa Tel: +27 12 649 0260 Allentown, PA, USA Tel: +1 610 391 0800 Seoul, Korea Tel: +82 70 4418 6677 Indianapolis, IN, USA Tel: +1 317 277 0337 Mt. Prospect, IL, USA Tel: +1 847 768 8180 Mexico City, Mexico Tel: +52 55 5696 7170


of 21

References

1. Research and Markets: Global Pre-filled Syringes Market to

2019: Glass-Based and Plastic-Based Analysis, February 11, 2014 2. “Studies Suggest that When it Comes to Drug Development

Success, Size Matters,” by Alex Philippidis, Genetic Engineering & Biotechnology News, April 9, 2012

3. Pre-filled Syringes Market Expected to Reach USD 4.98 Billion Globally in 2019: Transparency Market Research, November 21, 2013

4. Global pre-filled syringe market to reach $4.98 Billion in 2019, Jim Butschli, Packworld.com; November 21, 2013

5. “Pre-filled Syringes: The Next “Big Thing”?,” Cliff Mintz, Pharmaceutical Online, August 30, 2012

6. “Biotech Drug Approvals in the U.S. Nearly Doubled in the Last Decade,” Tufts Center for the Study of Drug Development press release, May 10, 2011

7. “Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically,” Tufts Center for the Study of Drug Development, Nov. 14, 2013

8. “Pre-filled Syringes Market, 2013-2023,” Roots Analysis Business Research & Consulting, July 1, 2013

9. “Top 100 Selling Drugs of 2013,” by Megan Brooks, Medscape, January 30, 2014

10. “Pre-filled Syringes,” PowerPoint presentation by Shrikanth Varma Bandi, Anurag Group of Institutions School of Pharmacy, June 14, 2012

11. “Future of Pre-filled Syringes: Manufacturer’s Perspective – Challenges and Opportunities;” by Paljit Mudhar, Frost & Sullivan, September 27, 2005

12. “Biologics industry to grow 9.3% between 2009 and 2016”, Manufacturing Chemist, September 21, 2010

13. White paper -- Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape; IMS Health, December 2011

14. Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention

15. Diabetes fact sheet, World Health Organization, October 2013 16. World Health Organization, Ageing and Life Course, 17. “Pre-filled syringes: An innovation in parenteral packaging”;

Sagar Makwana, Biswajit Basu, Uyogita Makasan and Abhay Dharamsi; International Journal of Pharmaceutical Investigation Oct-Dec 2011

18. “Pre-filled Syringes and Related Biologic Drug/Devices: Market Trends and Regulatory Acceptability;” Dr. Hoss A. Dowlat, Pharmaceutical Outsourcing, November/December 2013, 32-37

the growth & benefits of pre-filled syringes: what clinical … · 2019-10-30 · market a shot...

Documents