Enabling smooth, dual-market delivery of a kitted PFS biosimilar requiring terminal sterilization

When a global biosimilar company needed a flexible final assembly, kitting and packing partner with proven sterilization expertise, they came to Ensera.

We were able to provide agile capacity, sterile packaging advice, and sterilization management to support a smooth and timely launch in Europe, while preparing the program for future expansion into North America.

The challenge

The growing demand for combination products, alongside more stringent regulatory requirements for sterilization of drug-device components, is driving increased need for terminal sterilization services in pharma.

However, much like other pharmaceutical services (e.g. final assembly, secondary pack, fill-finish), industry capacity is largely allocated to blockbuster drugs. Low-to-medium volume projects, such as rare disease drugs, biosimilar launches and clinical runs are finding it hard to secure capacity and preferential timelines.

Within Europe, this complexity is compounded by diverse labeling and serialization requirements for products distributed across multiple countries.

This is the challenge our customer faced when they came to us looking for a partner for the final stages in preparing their kitted sterile PFS biosimilar product for market in both Europe and North America.

The solution

Since Ensera’s cleanroom pharma suites are modular by design, we already had semi-automated PFS assembly and labeling lines in place at our Poland and US facilities, with immediate capacity available. This approach provides flexibility to absorb changes in the timeline or delays further upstream – a common occurrence at this stage in the value chain, particularly for a new product launch.

With 25+ years of experience in the sterile medical device manufacturing sector, we advised on the most appropriate approach to packaging, kitting, sterile barrier system packing and sterilization management. These are all processes which we can manage on-site, between sites, or through our network of trusted partners.

The execution

With the set date for European launch imminent, we advocated a three-phased approach, prioritizing assembly and labeling of the PFS at our GMP pharma suites in Poland, where we then place it in a custom-designed tray, sealed with a Tyvek lid, before packing, serialization and aggregation. The packed kits are then sent to our sterilization partner for terminal sterilization.

Phase two will see us expanding our on-site sterilization capabilities to enable us to integrate and manage this stage in-house.

Phase three involves set up at our US site for launch into the US market, ensuring that all systems and equipment are replicated consistently across facilities.

To get to European launch stage efficiently and effectively, we supported full process validation and worked with our equipment suppliers to purchase the appropriate tooling. We also managed the design and production of the custom trays and Tyvek sterile barrier system with our network of local specialist partners.

This project is an excellent example of where Ensera adds real value to its customers: providing flexibility, speed, customization, sterilization management and packaging expertise, and supply chain management.

The impact

Certainty and operational clarity – by managing the final and most time-sensitive stage of the customer’s drug delivery supply chain.
Protected critical timelines – due to our flexible planning, phased approach and rapid batch switching.
Peace of mind – by providing expertise and management where the customer lacked experience
Scalable multi-market production – by providing a dual-site solution, the customer could be certain of continuity of infrastructure, processes and knowledge to support future market rollout.

With our long history of sterile device manufacturing, sterilization management expertise and our GMP certified pharma suites, this project was the perfect fit for Ensera and the customer. We’ve been able to deliver for them a custom solution at speed in Poland and then duplicate it in our US facility.

- John Ward, VP Pharma EMEA

Do you need flexible final assembly and sterile packing services for your next combination product?

Get in touch today. We’re ready to help.

Enquire now