Securing our future by boosting capacity

In 2021, Octapharma launched a number of production improvement initiatives to transform our manufacturing capabilities and boost capacity. 

“We are ever conscious that patients around the world depend on Octapharma to maintain a reliable supply of medicines,” explains Olivier Clairotte, Chief Production Officer. “To honour our commitments, and to become an even stronger and better company, we have an ambitious goal to massively increase our capacity over the next few years. In 2021, we successfully delivered the first improvements needed to achieve these initiatives and are looking forward to further success in the future.”

Embracing new ideas

One example of these improvements comes from Octapharma Sweden (OAB) in Stockholm, where the fractionation team has implemented a range of measures to optimise production efficiency and increase capacity. The fractionation team of about 100 employees, jointly headed by Max Färestål, produces Fraction I+II+III, Fraction II, cryoprecipitate, Fraction V and Antithrombin III (ATIII) intermediate which is then later used in the production process of Octapharma’s intravenous human normal immunoglobulin 5% and 10%, human coagulation factor VIII concentrate, albumin and human antithrombin III concentrate.

“Our objective is to increase manufacturing output by 15% in 2022, to ensure Octapharma can continue to fulfil our commitment to our patients and to secure our leading market position,” says Max. “With that in mind, we have improved some process steps enormously and are constantly looking to make further improvements.”

Right at the start of the process, a large project team was gathered. “The group we assembled had one target – to focus on how we could increase volume,” explains Max.

Very quickly, variations in process times were identified as an area the fractionation teams needed to focus on. “We saw that our product process times were fluctuating, and we had to understand why – not an easy task since a single batch takes about five days to complete,” explains Max. Workshops were held to facilitate creativity and encourage a clear thought process. “A lot of the workshops were focused on finding tools to visualise, making prioritisation easier for any critical steps later, increasing the information flow and allowing the standardisation of methods,” continues Max. 

Embracing new ways of doing things

As a result, new working standards and scheduling tools to pace production and decrease variation were put in place, as well as new systems to remove obstacles.

“We had to dig deep and examine every production step to identify bottlenecks and areas of improvement – challenging at times, but also rewarding and mostly fun,” explains Max. “Early in the process, our filter press and automatic cleaning (CIPs) systems became the focus of attention.

“After close analysis, we were able to significantly reduce total manual interventions in the filter press by 30 minutes per week, allowing an additional four batches per month to be processed, resulting in a 5% capacity increase by itself. Our improvements to the CIPs have seen them move from hitting only 50% of target process times in 2020 to now reaching 85% of their target performance, and still improving.”

“Beyond targeting these two bottlenecks, the team has also succeeded in reducing total average loss in plasma thawing from 1.8% to 1.4%, and our standard variation in process time has been greatly reduced, increasing our predictability by over 50%,” concludes Max.

Scaling up across the company

The Fractionation team in Stockholm is not the only one to embrace change: the production site at Lingolsheim in France also set itself a similar goal, with the ultimate objective of increasing production volume by 16%. “We worked on production organisation, of course, but also on equipment reliability, and communication within the Fractionation department,” explains Laurent Contet, Operational Excellence Manager, adding: “Several functions have been involved in the transformation wave, including Supply Chain, Quality and the Technical Unit.”

The Lingolsheim teams implemented a new meetings cascade to pilot the revised operations, with changes steadily adopted right across the site as the benefits of this new way of managing production became increasingly evident. The new meetings host discussions focused on production issues but also on safety, quality in operation and batch releases, and have become the forum for making immediate and important decisions needing site-wide commitment.

“From my perspective, the main lesson was that any team can achieve great things simply by dividing larger goals into realistic small changes. Moreover, it is always important to try new things and to accept that they are not always perfect immediately,” enthuses Julien Correia, Head of Fractionation.

FDA approval

While pursuing our transformation, Octapharma maintains a constant focus on quality. In 2021, the US Food and Drug Administration (FDA) approved a request to authorise the Octapharma production facility in Springe, Germany, as an additional manufacturing site for Fraction II. The FDA approval, given after its stringent assessment process, means Octapharma can produce Fraction II – which is used to produce Octapharma's intravenous human normal immunoglobulin– 5% and 10% – in Vienna for distribution in the USA, and can now also offer our products in a new fill volume.

Inspection Readiness initiative

The Inspection Readiness initiative aims to integrate all aspects of an official inspection into our day-to-day activities. In concrete terms, this process consists of identifying issues at risk of observation during inspection based on the Good Manufacturing Practice (GMP) Quality Risk Management International Conference on Harmonisation (ICH) Q9 model. Identified risks are then assessed and prioritised, and necessary actions taken to mitigate them. All Octapharma production sites have their Inspection Readiness initiatives in place.