close up of a virus

mRNA Storage - Finding the Ideal Solution

Selecting vials for speed to market or prefillable syringes (PFS) for ease of use and flexibility. Industry-standard syriQ® glass PFS are proven at temperatures down to -50°C and SCHOTT TOPPAC® polymer PFS down to -100°C, making them a great solution for the storage of mRNA drugs. We have the solution to support your mRNA storage and transport needs.

mRNA challenges

mRNA applications are a challenge for primary packaging

The demanding low temperature storage and transport conditions of mRNA applications put additional strain on the primary packaging system container. Cold chain conditions and the freeze-thaw cycle can impact mechanical stability, performance, container closure integrity and particulate levels. All these potential risks must be understood to launch an mRNA drug with confidence.

Low temperatures that are required for mRNA transport and storage bring up technical challenges for its primary packaging
Packaging solutions

Overcoming mRNA application challenges with SCHOTT Pharma

Fast time-to-market? Using a PFS for more convenience? Extremely cold and challenging supply and storage conditions? Issues with drug container interactions? Technical and unbiased support?

A polymer prefillable syringe is a solution for deep cold drug storage and transport
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SCHOTT TOPPAC® polymer syringes - a solution for low temperatures down to -100°C

The Cyclic Olefin Copolymer syringe allows for CCI at -100°C. With extremely low sub-visible particles, no ion or heavy metal release and an immobilized cross-linked siliconization, this syringe minimizes drug interaction.

A glass prefillable syringe that offers suitability for low temperature mRNA vaccines
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syriQ® glass syringes for temperatures down to -50°C

With proven CCI, reliable functionality, low particulate at -50°C and with an already established Fill-and-Finish network, syriQ(R) syringes offer suitability for low temperature mRNA applications and the ease for scale up.

A vial being a possible containment solution for low temperature mRNA vaccines
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SCHOTT Vials are ideal for fast time-to-market

With a broad range of coating options, designs and formats, there is a vial for your needs. To back this up, a data package is currently being generated, demonstrating that SCHOTT Vials meet the requirements of mRNA applications.

Vials in a testing situation at SCHOTT pharma services
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SCHOTT Pharma Services helps to understand container - drug interaction

SCHOTT has over 40 years of experience in analytics, combining an expert team with the latest technology for precise results. From drug compatibility and extractables and leachables studies to system performance and mechanical stability testing, we offer insight and support for all packaging challenges.

Data and test results

Data and results

Testing data for various topics like sterility, CCI, potential drug-container interaction or functionality helps to better understand the aspects of a safe mRNA storage.

Polymer syringes ideally suited for low temperature mRNA applications.

Sterility barrier can be controlled with the right syringe components and F&F parameters.

Sterility barrier can be controlled with the right syringe components and F&F parameters

*Headspace size, the type of plunger as well as the filling volume impact the plunger movement.

Container closure integrity (CCI) is maintained even at -100°C.

Container closure integrity can be maintained even in deep cold temperatures


Reduced risk for drug interaction and sub-visible particles with a cross-linked siliconization process.

  Time Free silicone [mg/L]
3x frozen at -20°C
and thawed
Free silicone compared
to standard SCHOTT
TOPPAC®
Free silicone [mg/L]
stored at 5°C
Free silicone compared
to standard SCHOTT
TOPPAC®

SCHOTT TOPPAC® cross-linked
siliconization

Standard cross-linked silicone
0d 0.23 N/A < 0.2 N/A
SCHOTT TOPPAC® sprayed
siliconization

Sprayed on DC360, 0.55 mg/barrel
 0d 5.6 24 times 1.09 5 times

 

*After 3 cycles of freezing and thawing at -20°C, the leachable silicone quantities increase for both siliconization technologies, but sprayed silicone is much more affected. We see 24 times more free silicone oil for the syringe siliconized with sprayed on siliconization. The lubrication technology matters for drug stability. An immobilized cross-linked siliconization lowers the risk for any drug interaction.

Normal syringe functionality even in deep-cold temperatures.

All normal polymer syringe functionalities remain unchanged after 3 times freeze/thaw and no residual risks were identified after several studies:

  • No change of transparency
  • No decrease in mechanical stability
  • No change of optical appearance

 

The normal functionalities of a polymer syringe remain unchanged even after freezing-thawing cycles

*No difference in break loose and gliding force was observed at the different temperatures and results were comparable to syringes stored at room temperature. Indicating a freezing-thawing cycle doesn't have a significant impact on functionality.

Glass prefillable syringes ideally suited for low temperature mRNA applications down to -50°C.

None of the tested plungers shown here breach the safety margin: Deep cold temperatures have a complex effect on plunger movement. We proved the integrity of the sterility barrier with different controlled fill-finish parameters.*

Sterility barrier can be controlled with the right syringe components and F&F parameters

*syriQ® 1ml long glass syringe with SRC; WFI fill medium shown here. Data for other systems available.

A widely-referenced test method* based on headspace analysis proved container closure integrity down to -50°C for different glass prefillable syringe systems (PFS).

Container closure integrity can be maintained in freezing temperatures

* For each PFS system, 15 empty syringes were stored for 24 hours on dry ice at -50°C. The syringes were tested with qualified  Lighthouse instruments FMS-Carbon Dioxide Headspace Analyzer (Model FMS-CO2). No test samples showed signs of CO2 ingress.

Burst pressure results showed mechanical strength resilience through the freeze-thaw cycle.*

naffacted mechanical strength resilience, torque strength and optical properties in cold temperatures.

*75 syringes tested pre- and post-freezing at -50°C, using buffers and a freeze-thaw cycle designed to simulate the mRNA cold chain.

Torque strength and Luer Lock adapter connectivity were unaffected, and out of 900 syringes we observed no changes to optical properties.

syriQ® Rigid Cap (SRC)  SCHOTT`s Luer Lock closure system for syriQ® PFS

Injection performance (break-loose & gliding force, BLGF) for syriQ® glass syringes is minimally impacted following the freeze-thaw cycle in the deep cold temperature range.

The normal functionalities of a glass syringe remain unchanged even after freezing-thawing cycles

*Example: syriQ® 1ml long glass syringe with SRC; data for other systems available.

SCHOTT Pharma as a right partner for mRNA technology

  • Optimal drug containment solutions available for every life cycle phase: from vials to prefillable syringes.
  • Unbiased consulting and support for pre-fillable syringes depending on the application's need.
  • SCHOTT Pharma Services provides drug container compatibility testing for multiple drug developments

Combination of polymer and glass containment solutions and extensive experience with the COVID-19 mRNA technology are bundled
Whitepaper download

Great insights about packaging low-temperature mRNA vaccine packaging.

Learn all about the key considerations in selecting a polymer prefilled syringe as a low-temperature mRNA vaccine packaging.

Whitepaper preview about packaging low-temperature mRNA vaccines

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Frequently asked questions

As mRNA drugs are becoming increasingly popular in the pharmaceutical industry, they are now used to treat genetic diseases, viral infections, and COVID vaccines. Their potential is yet to be fully taken advantage of, especially when it comes to the use of mRNA drugs in vaccines.

Get in touch

Christoph Zauner

Christoph Zauner

Head of Product Management Polymer Solutions

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