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Drug Product Sensitivity Requires Innovative Packaging and Distribution Solution

Our client, one of the top major pharmaceutical companies, approached Fisher Clinical Services Horsham with a challenging study – a large, double blinded Phase III study involving precise syringe compilation with need to find an optimal packaging solution for transportation of supplies across multiple countries. Two additional complexities were identified: the IMP was extremely light sensitive and temperature sensitive, and timeframes were tight with FPI date looming. Having worked with Fisher Clinical Services Horsham before, the Sponsor was confident that a solution would be found to address these complexities. There was an expectation that Fisher Clinical Services Horsham would provide the following services – packaging component design, labelling, packaging, distribution, returns and destruction.

Challenges faced for Fisher Clinical Servies:

  • The IMP was filled into a syringe and for blinding purposes the plunger rods had to be replaced. The position of the plunger rod was essential as any movement would impact the sterility of the IMP. Precision was paramount.
  • The appearance of the active drug (IMP) and the placebo drug had to be identical
  • The IMP was temperature and light sensitive, requiring special considerations for packaging, labelling and distribution
  • As this trial was to be conducted in multiple countries across the world, careful consideration had to be given to how the IMP would be transported globally and the best way to overcome any impact of air pressure when transporting the product by air
  • Time was of the essence as the packaging volume was large with the FPI (First Patient In) date looming close

Team Collaboration
Fisher Clinical Services Horsham nominated team members from across all departments to work together to find solutions to address the complexities of this trial. In an effort to shorten the project timeline regular update meetings were scheduled with the Sponsor so that everyone was involved in making decisions on customised packaging, labelling, distribution processes for this particular trial. As Fisher Clinical Services has been solely focused on clinical trials for over 25 years, with Subject Matter Experts in Horsham and in our strategically located GMP facilities across the globe, a creative and innovative packaging and distribution solution was defined to address the complexities of this trial.

Engineering Innovation leads to new packaging design solution
From the outset, all team members understood the complexities of the drug product and the parameter dynamics of working with these supplies. It was confirmed that the sterility of drug needed to be maintained at all times. The sterility of the IMP in the pre-filled syringes would become compromised if the plunger rod movement was out of the tolerated range. To this end, the Fisher Clinical Services team of engineers developed new technology that would monitor and detect the plunger rod position, using automated technology, and removing any reliance on using the human eye to gauge accuracy of the position. Any syringes that failed to meet the defined parameters for plunger position were rejected on the line before it exceeded the tolerance level. These rejected syringes were then reprocessed ensuring that there was no unnecessary wastage of valuable drug product and ancillaries for the Sponsor.

The result is a new solution that can be utilised globally in both ambient and cold conditions, also known as ProSyries, providing quality and innovation to syringe assembly. This solution:

  • Reduces variability and risk through quality driven, global, automated processes and equipment
  • Maximizes flexibility to meet the needs of every trial and every syringe. This quality-driven automated and semi-automated processes can meet the needs of multiple fill sizes
  • Safeguards patient and medical staff
  • Eliminates bottlenecks and delivers efficiency

Design solution to minimize movement in transit
Secondly, delivery of these pre-filled syringes intact presented another challenge to the Horsham team as these supplies were included in protocols involving multiple countries across the world, hence involving air travel. The team of engineers at Horsham approached this challenge by running tests with direct comparisons on atmospheric conditions in a vacuum chamber environment.

An innovative tray was designed to eliminate the plunger rod movement in the atmospheric conditions that the IMP would face during air transit. Samples of this tray were designed and developed in-house, using cutting edge 3D technology and simulation software. These samples were used as a proof of concept so that the Horsham team could approve and validate the design before producing large supplies to accommodate the quantities needed for this large trial.

Eliminating Time Out of Environment (TOE)
An important complexity to address was the fact that the IMP was extremely sensitive to both light and temperature. It was determined that the IMP could not be exposed to ambient conditions or to direct sunlight during packaging or distribution as this would impact on product sterility. The Fisher Clinical Services Horsham facility benefits from being able to receive drug into the regulated and controlled cold chain warehouse at 2 – 8°C. In addition, processes for packaging, labelling and for pack down into validated cold chain shippers, all within the 2-8°C environment.

To overcome the challenge of light sensitivity, the Horsham engineering and operational team of experts devised a solution to convert the packaging rooms in the cold chain environment to block out any light sources and to product from light to industry standards of <500 nanometres, which includes UV rays.

To this end, the IMP was maintained at 2 – 8°C throughout all packaging, labelling and distribution processes with no Time Out of Environment and zero excursion to ambient temperature and light.

In Summary
This complex packaging, labelling and distribution project presented many challenges for the Sponsor which in turn provided an opportunity for Fisher Clinical Services to deliver innovative solutions to address these complexities. With a sole focus on clinical trials for over 25 years, a dedicated team of experts at Fisher Clinical Services through the use of cutting edge technology and creative thinking, was able to successfully execute the packaging, labelling and distribution requirements of this large, complex Phase III trial across many countries.

In fact, online speed and efficiencies were increased by an impressive 66%. All supplies were delivered On Time and In Full without compromise to patients. This demonstrates that innovation, expertise and operational excellence were paramount to the success of this trial.

 

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