CLINICALTRIAL
PACKAGING
SMART CHOICESCAN TRIM TIMELINES

Introduction

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How your product will be used by patientsand healthcare providers

4

How packaging and production options
meet emerging biopharma trends

5

Automated or manual production? Or both?

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Take full advantage of packaging experts

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Introduction
Getting a potential new therapy through the clinical
trial process takes more time than ever before.
Protocols are growing increasingly complex. Plus,many trials have trouble enrolling enough patients,
and those who do enroll may have difficulty following
the protocol and drop out. Complicating mattersfurther, many drugs being developed are expensive
biologic agents, leaving little margin for error in theclinical trial strategy.

Delays in getting a therapy approved mean less time to secure commercial
success and recoup investments before generic forms are available. Most
importantly, it delays getting potentially lifesaving drugs to patients. As aresult, sponsoring companies look for ways to trim development timelines.
Establishing an efficient drug packaging strategy for a clinical trial is notoften recognized as a potential timesaver, but it should be. A well- thoughtout packaging strategy can significantly cut your clinical trial timelines andincrease the likelihood of a successful trial.
There are several critical factors that sponsors need to consider about
packaging: the drug’s form requirements (injection, oral solid dose, etc.), thevolume needed for the trial (lot size, trial duration), temperature requirements(freeze/thaw cycles, handling requirements), and whether the drug needs tobe protected from light.
Taking those and other factors into account, experts at Thermo Fisher Scientificoutline four key considerations that sponsors should evaluate when developing
a packaging strategy:

1. What do your patients and healthcare providers need?
2. What packaging options meet the needs of your drug?
3. Can your packaging process be automated?
4. Do you have in-house expertise?

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How your product will be used bypatients and healthcare providers
The first thing to consider is how your product will
be used by patients and healthcare providers involvedin your clinical trial. If your packaging meets their
day-to-day needs, they will find it easier to follow thetrial protocol.
Drug distribution
How and where will the drug be administered to patients? There are many
nuances to this issue that can affect packaging decisions.
For example, does the patient also need supporting materials? If the patient
will get the drug at a doctor’s office, packaging the drug and supporting
materials in one container might work. In many cases, however, the drug
needs to be delivered to a pharmacy and other materials to the doctor’soffice. “If it is all packaged together, you’re making the package unnecessarilylarge, plus you’re sending it to the wrong place,” says Helen Underwood,
Director of Strategic Client Relationships. That can cause significant delays ingetting doses to patients.
What about drugs that are given to patients only once? For example, consider
a vaccine that doctors will be delivering to large numbers of people in a rural
setting. “You want something that the doctor can handle quickly, treat many
patients when speed is of the essence, and then dispose of efficiently,” says
Underwood. “You don’t want them to spend time assembling a syringe.”

Drug dosing
How often is the patient expected to take the medication? Once a day?
Several times a day? If the latter, the drug might need to be ina small package the patient can bring to work, such as a blister pack that
holds just a few pills. On the other hand, if the patient needs to take themedication just once in the morning, a less portable package might work fine.
If your medication must be injected, will your patients want to visit ahealthcare provider regularly for injections? Or would they find thatcumbersome, and perhaps be comfortable with administering it themselveswith a prefilled syringe or auto-injector?

Patient demographics
What age are your patients? Children might object to daily injections. Seniors
can find it difficult to inject themselves. What other demographic or lifestylefactors might influence your patients’ packaging preferences?
Regardless of who your target enrollees are, if patients or providers find it
difficult to follow your clinical trial protocol because of packaging details, they
are less likely to follow the protocol correctly, and you may need to enroll evenmore patients.
A packaging expert can help sponsors to consider these and many other
patient and provider usage considerations.

If patients or providers find it difficult to follow yourclinical trial protocol because of packaging details,
they are less likely to follow the protocol correctly,
and you may need to enroll even more patients.
4How packaging and production options
meet emerging biopharma trends
Healthcare and the pharmaceutical industry arechanging rapidly. Several recent trends should betaken into account when thinking about clinical trial
packaging options: the rise of precision medicine,the popularity of biological therapies and prefilled
syringes, and cold-chain processing.
PRECISION MEDICINE IS ON THE RISE
Precision medicine—the use of therapies tailored to subsets of patients basedon their unique molecular and genetic profiles—is on the rise. These drugs,
by definition, are intended for relatively small numbers of patients. A clinical
trial sponsor may need only small quantities of their therapy, which means asmaller production run and potentially higher costs. In addition to exploring
packaging that can be produced at a reasonable cost, sponsors need toconsider whether the packager can scale up production in the future. Moving
your packaging operation to a new vendor can mean costly delays whenlaunching later-phase clinical trials.

BIOLOGICAL THERAPIES AND PREFILLEDSYRINGES ARE ON THE RISE
Rising alongside precision medicine are biological therapies, a relatively newclass of drugs that are produced from biological materials.
Most biologics are large-molecule products in liquid form. Many are deliveredby injection. In today’s healthcare climate, more patients are comfortablewith injecting medications on their own, especially if they have a chronic
disease such as diabetes that requires frequent dosing.
This has led to an increase in use of prefilled syringes, a disposable drugdelivery system that is filled with a precise dose of medication, as a
packaging option.
Producing prefilled syringes used to be a time-consuming process that wasdone by hand. These days, however, some packagers can use automatedprocesses to fill syringes, significantly cutting production time. For example,
10 people manually assembling prefilled syringes could produce about 400
units per day. Using automated processes, it’s now possible to produce
13,000 units per day.
In addition, automated processes fill the syringes more precisely thanhumans, cutting down on product waste. A more precise dose can also mean
fewer protocol deviations, and fewer patients producing unusable data or
dropping out.
“Biologics are incredibly expensive products,” says Underwood. “You want
all of the product to get to the patient. You want a delivery system that’s
going to perform the right level of dosing with the greatest ease. The prefilledsyringe is an ideal way to do that.”

Automated processes fill the syringes more
precisely than humans, cutting down on
product waste.

It’s also important to know how syringe production is carried out at afacility. Not all systems are equally efficient or error-proof. For example, wehave eliminated glass-to-glass and glass-to-steel contact, eliminating thepossibility of cracked or scratched syringes, which can cause units to be
rejected and slow down production.

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How packaging and production options meet emerging biopharma trends (continued)
COLD-CHAIN PROCESSING
Most biologics require refrigeration. They degrade at ambient temperatures,and remain more stable if refrigerated. They must be assembled, labeled,and packaged in a temperature-controlled room, and shipped in special
packaging with careful monitoring at every step to ensure that their time out ofenvironment (TOE) is limited.
Such cold-chain processing can be complex. For example, manual labelingat very cold temperatures is challenging. Operators need personal protective
equipment, but it’s very difficult to apply labels to packages while wearing
thick gloves. Our Thermo Fisher Scientific facilities have cold rooms with theability to package and label drugs at minus 80 degrees, notes Shawn Regits,
Process Engineering Manager.

It’s also important to make sure your packager can get your product shipped
to clinical sites in a timely manner with minimal or zero TOE. Packagers haveadvanced far beyond the old dry ice technologies. Today, some can packthe finished product in “smart boxes,” containers that keep products coolwhen in transit but go into a resting state when they detect they are being
stored in a refrigerator.
In addition, sophisticated temperature monitors on shipping packages can
now make it easier for clinicians to see if a product has spent too much timeout of its required temperature range, providing certainty that a product is still
viable. Products that have not been properly cooled, or are even suspected of
not having been properly cooled, may be disposed of by clinicians, leading todelays and increased costs.

It’s vital to choose a vendor that can do cold-chain processing and has thecapacity to meet your production needs in a timely manner. Choosing avendor that has only limited cold-chain capacity could mean your packaging
run gets delayed while other jobs are completed.

6Automated or manual production? Or both?
“Many people have the misconception that clinical
trial packaging is all done manually,” says Underwood.
“I want to dispel that myth.”
Underwood notes that Thermo Fisher Scientific has large-scale automatedequipment for large trials, but also smaller-scale equipment that can handle
smaller runs. “We just need to understand the type of trial and the trial phaseto make an appropriate match.”
Automated assembly increases consistency and control, and lowers the riskof human error. The assembly equipment can also run for long periods oftime, much longer than a human. But while automated assembly is fast, fullautomation can also mean longer lead times due to up-front engineeringand design needs.
Manual assembly will be slower, but has the advantage of requiring lesssetup time.
“In many cases, the best option is a semi-automated solution,” says Regits.
“For example, a machine would do the critical packaging step or inspection,
and a human operator would load components into the machine.” A semiautomated solution can achieve a good balance of start-up time, flexibility,and labor.
Decisions on whether to automate or not depend primarily on the study
design, volume, and timelines (including whether a study might run over
several years), rather than technology, adds Underwood.

While automated assembly is fast, full automation
can also mean longer lead times due to up-front
engineering and design needs.
7Take full advantage of packaging experts
Working with outside packaging experts can speed up
your clinical trial.
Not all trial sponsors have the resources of a large pharmaceutical company
at their disposal. Many companies seeking to launch drugs are small andentrepreneurial. For them, partnering early on with packaging experts such as
the Thermo Fisher Scientific team can reap major benefits. Experts can bringingenuity and a sophisticated packaging plan to a project that will significantly
cut timelines and increase patient compliance with your protocol.
“We work with clients to understand their true needs, what’s really importantto their product,” says Regits. Sponsors are usually juggling many competingneeds, such as volume requirements, refrigeration needs, clinical trial timelines,costs, possibly scaling up production for later phases, and more, he notes.
“Sometimes you have to distill it down, peel the onion and figure out what
they really need,” he says. “And then find the right solution. There are athousand different ways to solve a problem, but what is the right solution forthat client?” Finding the best solution often requires brainstorming sessions
involving experts in operations, engineering, and other areas.

“We do our best to error-proof the process, to design processes where errors
are impossible, and then we standardize those processes and make themavailable to our clients,” he adds.
“When clients come to us with an open mind, we can ask probing 12questions, find out more about their product and how it’s going to be used,”says Underwood. “We can make recommendations about how it might beused by a patient, lead into package design, automation options, and theproduction strategy we would deploy. We pull it all together into a holisticsupply and packaging strategy.”
Indeed, partnering with packaging experts such as the the Thermo Fisher
Scientific team can streamline processes and cut overall timelines. Our
experts can help you to:•

Fully explore the needs and preferences of your patients and healthcare
providers, and the packaging options that will work for them•Take full advantage of innovative packaging options, such as small
production runs and cold-chain processing, that meet the needs of yourdrug and clinical trial•

Determine the best processing options for your packaging, whether it’s
fully automated, fully manual, or a combination of options•Take full advantage of our years of experience working with a multitude oftrials, therapies, and packaging design options

Most importantly, our experts can help you develop a more efficient clinical
trial strategy and ensure that your patients and healthcare providers are fully
engaged in your protocol.

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+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
Published 09/21