Recipharm evolves its sterile fill & finish facilities to meet current and future demands

The rapid growth of the global fill & finish manufacturing market – predicted to increase in value from US$6.1 billion in 2019 to US$12.6 billion by 2027 – is driven by multiple factors. One is the rise of the biopharmaceutical sector and the subsequent growth of parenterally-delivered drugs in development. Demand for sterile parenteral drugs has been further escalated by the COVID-19 pandemic, leading to the immediate and global need for vaccines. 

Contract development and manufacturing organisations (CDMOs) have been under constant pressure from the onset of the pandemic to deliver fill & finish services to meet this surge in demand. Whether achieving this through improving efficiency, optimising existing capacity, or expansion of facilities, CDMOs will often face significant challenges along the way.  

Obstacles to expansion and improving productivity

In an era where COVID-19 related supply chain difficulties are commonplace, meeting the upsurge in demand for sterile fill & finish capacity is no simple task. If considering expansion by building additional infrastructure, CDMOs could face extended timelines for construction, as demand for these services has understandably increased globally, particularly in the biopharmaceutical sector.  

Upgrading existing production lines is also a complex process. It is common for CDMOs to rely on well-maintained legacy machinery that still provides valuable services. However, sourcing compatible replacement components can be a significant challenge. Additionally, adoption of add-on technologies or implementation of upgrades to these legacy machines while meeting changing sterile process legislation can be difficult. Tailoring insulators or restricted access barrier systems (RABS) can also be costly. 

Above all, CDMOs must determine whether chosen improvements to fill & finish capacities are financially wise. The line being upgraded must be shut down for the duration of the work, impacting on production output and on their ability to meet existing customer demand.

Expanding fill & finish capacity in Monts, France

As a CDMO offering sterile fill & finish services, we are no stranger to the challenges of meeting rising demand through expansion and the need for novel methods to solve them. This was highlighted in the expansion of our specialist aseptic manufacturing facility in Monts. 

Originally built in the 1940s, the Monts facility was retrofitted for pharmaceutical production in the 1980s and specialised in fill & finishing for generic and biologic products. It also contained well-maintained legacy equipment. 

With the onset of the COVID-19 pandemic, demand for sterile filling set to increase and remain high in future, and changes to sterile processing legislation on the horizon, the Monts site required upgraded sterile processes and additional capacity. These had to complement and integrate into the existing facility. 

The benefits of a prefabrication approach

At Recipharm, we believe that the answer to these challenges is prefabrication, where cleanrooms are manufactured in modular sections off-site, transported to the facility, and integrated with neighbouring sections before process equipment is introduced. 

This approach offers the benefits of being both highly time-efficient and cost-effective. Expansions that would typically take 18 months can be shortened to six months with prefabrication. It also offers the benefit of streamlining the validation process. This is facilitated by its modular approach, allowing functionality of cleanrooms, process equipment, and RABs to be tested by each supplier before transportation.   

Utilising prefabrication in Monts

The project has been designed to allow the continued use of the existing production lines at Monts during the build, allowing the site to remain fully operational. Outsourcing of the development and cleanroom modules ensures that the creation and installation of equipment and cleanrooms were decoupled from the construction of the new buildings. 

Cleanrooms were manufactured in modular sections off-site by a specialist prefab supplier in Spain according to the needs of the line. Each section was then transported in a total of 30 deliveries to the facility and integrated with neighbouring sections before the process equipment was introduced.

The required process components and equipment were sourced from a supplier in China and fitted together within a RABS unit. All the process equipment was shipped to France in less than 6 months. 

The new capacity in Monts is set to be fully operational in summer 2022 and has already delivered batches of COVID-19 vaccines. With 16 fill heads in the new line, faster production has been achieved, enabling Monts to deliver over 500,000 units per day. The additional capacity is also flexible, offering easy and rapid changeover for new projects and allowing Recipharm to respond quickly to a range of requests. 

Our experience at Monts highlights the benefits of opting for a prefabrication approach to expand fill & finish capacity to respond to increasing demand. Learning from this example and implementing this method in their own expansion efforts, CDMOs can minimise operational disruption and be well placed to continue to support pharma developers in the future. 

Looking ahead

High demand for parenteral drug products will likely continue for the foreseeable future, necessitating manufacturers to invest in novel construction methods like prefabrication to deliver highly efficient fill & finish capacity. 

With the successful expansion of Monts’ fill & finish capacity using prefabrication, we are now considering its use in both the construction of its new facility in Morocco and a potential second expansion at Monts. Implementing most of the process equipment into the cleanroom modules prior to their delivery to the new site could further shorten timelines in capacity expansion. 

As demand for fill & finish capacity increases, continued expansion will be essential. Exploration into potential future technologies could also further enhance productivity and line flexibility. Robotics could be utilised to eliminate manual handling requirements and 3D printing technologies could be leveraged to manufacture specific tools on site. In this way, manufacturers can ensure fill & finish capabilities will be flexible and ready to support innovative biotech companies and their projects in future. 

Find out more about our sterile fill finish services here.