Traceability requires close collaboration across many functions. The plasma donation centers are responsible for the collection of all relevant data for each plasma donation – including the donor’s unique identification number, blood type, date of the donation, donor center, plasma volume and type (source or recovered plasma).
Before any plasma can be released for use in production, each donation must be independently verified to confirm that the donation complies with all release criteria. This is the task of the Corporate Quality Plasma teams in our manufacturing sites in Vienna (Austria), Stockholm (Sweden), Springe (Germany) and Lingolsheim (France).
Octapharma processes annually over six million litres of plasma donated by hundreds of thousands of committed donors. This equates to more than ten million individual donations.
Each data set requires protocol management, coordination with local sites and, above all, accurate and precise collaboration of local and global team members. “The ability to collect and access vast data sets of plasma donations is the foundation of our team. Traceability is important for safe and efficient manufacturing of our medicines,” explains Angelika Hurtl, who leads the Corporate Quality Plasma team in Vienna.
“The ability to collect and access vast data sets of plasma donations is the foundation of our team. Traceability is important for safe and efficient manufacturing of our medicines.”
The ability to collect and access vast data sets of plasma donations is the foundation of our team. Traceability is important for safe and efficient manufacturing of our medicines.
Traceability is the ability to track all relevant information about a plasma donation throughout its lifecycle – from the time of the donation itself, throughout the manufacturing process to when the medicines are produced and Quality Control released for patients around the world.
Angelika and her team monitor all information from the donor center to manufacturing. “For instance, you may want to know what kind of plasma the end product has been produced from, or from which country or donation center the plasma came from, even how many units were used – this is all traceability. It also includes information on specific donation dates, or potential deviations during transport.”
Besides the compliant aspect of traceability, Angelika says that the collected data has also transformed the way we look at efficient production. “We are a data company in healthcare, but also a data-driven organisation,” she explains.
We understand the story our data is telling us. We are used to generating and working with huge amounts of data, analyzing it and using this knowledge for further development of streamlined planning and workflows.
We are proud to say that we master our field and our plasma donations are fully compliant. All our local teams should also be more than proud of their achievements.
Human plasma is a precious resource for developing our novel plasma derived therapeutic protein medicines. It is the clear, straw-colored liquid portion of blood that remains after all cellular components are removed. Of the plasma which Octapharma processes, we collect the vast majority ourselves through more than 100 donation centers which we operate in the USA and Germany.
Each plasma donation is stored in a bottle or a bag. After the verification of all quality requirements, the respective individual data set is released and scanned during the process of physical acceptance. This process is called Single Donation Control (SDC). SDC is the proven foundation of traceability for all individual plasma donations in Octapharma. After the SDC step, Angelika’s team must approve the plasma for use in production. Every donation is crosschecked to confirm its compliance – for example, that it is really from the particular donor listed in the documentation, that the virus testing result was negative, that there were no temperature deviations during shipment to our manufacturing sites in Europe, that there are no look-back or post-donation notifications, and so on.
Individual plasma donations are released for production only if all relevant data is in compliance with many parameters. “It is a very complex process,” adds Angelika. “To have all plasma units in compliance with all required parameters also means, for instance, to analyse matching plasma units by their age, blood type or origin.
“After passing that final check, the plasma unit can be used for production in conjunction with the number of units which is needed to fulfill the needed plasma pool size,” she continues. “One plasma pool can be formed from many donations, anywhere from 700 up to 16,000 donations. We must ensure that we know exactly and at all times which plasma units have been used in the production of each batch of our medicines sold all around the world.”
After SDC, plasma is transferred to production by the logistics department. The basic fractionation department then begins the process of thawing the plasma donations and forming the plasma pools. Freezing and storage parameters follow defined standard operating procedures in which the plasma units are thawed for pooling and then production. Production involves separating out the relevant proteins from the plasma, firstly in an intermediate step via fractions or pastes, which are then purified and put into Octapharma finished products used by patients around the world.
By maintaining this digital thread of information, Octapharma is able to trace each individual donation at all times.
“We are proud to say that we master our field and our plasma donations are fully compliant. All our local teams should also be more than proud of their achievements,” adds Angelika.
Traceability means delivering to the business requirements, where accurate teamwork is essential. Angelika considers team spirit to be the secret behind making traceability a reality. The team she leads is very diverse and this allows them to contribute their individual strengths.
What I appreciate best about the team is the cooperation among the experts and the willingness to step in if support is needed.
Traceability is critical for quality in production and patient safety. “We are a partner in the production process and our colleagues really depend on us,” concludes Angelika.