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Small-batch, high-value aseptic manufacturing solution for Eramol

Case Study

Small-batch, high-value aseptic manufacturing solution for Eramol

Eramol is a CDMO focused on the development and manufacture of sterile, high-value medicinal products. The company’s portfolio includes complex formulations such as vaccines and suspension-based therapies, all produced within a highly regulated GMP environment.Screenshot 2026-04-21 150703

As the business has grown, Eramol has evolved from a virtual QP service provider into a company with a clear ambition: to deliver a fully integrated, end-to-end clinical manufacturing offering.

 

Challenge

As Eramol expanded its capabilities, several key challenges emerged:

  • A clear gap in the UK clinical trials market for flexible, small-batch sterile manufacturing.

  • Increasing demand for small-scale, high-value API processing.

  • The need to bring critical services in-house and reduce reliance on external providers.

Eramol required a robust aseptic liquid fill-finish solution to support small-scale, high-value API processing. Initially, the plan was to install an isolator and integrate equipment internally. However, it quickly became clear that this approach would not deliver the required performance or compliance. A more holistic, fully integrated system was needed.

The Solution

We partnered with Eramol and IWT to deliver a fully integrated, turnkey aseptic fill-finish solution. IWT supplied the isolator, creating a closed and controlled sterile environment, while we delivered the aseptic filling equipment within the system.

The solution is centred on liquid filling of vials, incorporating advanced technologies such as our Liquid Fill-Finish Platform and integrated Rotary Crimper. Designed with flexibility in mind, the system supports multiple container formats, with an initial focus on vials and future capability for cartridges and syringes. Rather than combining standalone components, we engineered the entire solution as a cohesive system from the outset. It is fully aligned with modern regulatory expectations, including Annex 1, ensuring robust sterility assurance, operational efficiency, and long-term scalability.

Before the project, Eramol evaluated multiple suppliers, but we stood out in several key areas. We demonstrated sterility assurance with confidence, applied a design philosophy aligned with Annex 1 from the beginning rather than retrofitted compliance and maintained a strong focus on data generation and process understanding.

'Fail Fast' Approach 

A full ergonomic mock- up was key to optimising the system design, revealed that the original configuration overloaded the working chamber. This led to key improvements including an additional chamber, enhanced operator workflow and accessibility, and support for continuous processing - eliminating batch size limitations. Identifying layout constraints early also allowed for necessary facility modifications ahead of installation. Overall, this “fail fast” approach prevented costly issues later in the project and significantly improved the final design. Importantly, the collaboration between Eramol, 3P innovation and IWT resulted in:

  • Strong technical knowledge exchange.
  • Clear alignment on system design and regulatory expectations.
  • Structured project delivery despite differing organisational styles.

Impact

The new aseptic processing capability delivers significant advantages for both Eramol and its customers. For Eramol, it marks a successful transition toward a fully integrated service offering, strengthening its position as a flexible clinical manufacturing partner while increasing control over quality, timelines and delivery.

For customers, it provides access to small-batch, high-value manufacturing with reduced product waste compared to large-scale CDMOs, alongside faster turnaround times and greater flexibility for early-stage clinical trials. Overall, the solution opens up a previously underserved segment of the market.

Client testimonial

"This turnkey solution, led by 3P innovation in collaboration with IWT, demonstrated the strength of a highly integrated, three-way partnership. Each organisation brought complementary expertise across engineering, compliance, and process development, resulting in a cohesive and well-executed solution. From initial concept through to implementation, the team maintained a strong focus on delivering a flexible and robust system aligned with Eramol’s operational needs. The solution achieved minimal line losses for liquid fill products while enabling increased flexibility in presentation formats for sterile liquid products. This is particularly valuable in supporting early-stage IMP manufacturing, where adaptability and efficiency are critical. Importantly, the system was designed and delivered in full alignment with the latest EU GMP Annex 1 requirements, ensuring both compliance and future readiness. The collaborative approach, technical capability, and commitment to quality shown by 3P innovation and IWT were instrumental in the project’s success, and we would confidently recommend them as partners for complex aseptic processing solutions. "

David Cox, Eramol.

 

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