Safety & Manufacture Of Our Plasma Therapies


To better bring our therapies closer to patients, CSL has started to manufacture the same products at multiple locations around the world. One example of CSL’s commitment to maintaining the same high standards to all of our patients worldwide is the launch of a global change control system, which is now utilised by all CSL Behring production sites. To support our culture of continuous improvement, this electronic system assures that any changes implemented to qualified systems, equipment and facilities are visible to all other sites and controlled in the same manner. This system was launched in November 2015, and assures that manufacturing processes and quality standards remain the same regardless of the manufacturing site location.

Similarly, CSL has been diligently focused on completion of a global laboratory information system, which is scheduled to go live beginning in the second quarter of 2017. This project will bring all manufacturing sites into a single database to allow for enhanced product and process monitoring capabilities. This is especially beneficial when managing production of the same product at several locations.

The training and documentation of staff qualifications is a key compliance requirement in the pharmaceutical industry. To support meeting this expectation in 2015/16, CSL extended its electronic training system to over 30 business locations globally. This aids in the rapid deployment of training materials and documentation/reporting of qualification status for personnel around the world.

CSL also went live with a global contract management system that is now utilised to process and archive all quality agreements between CSL and business partners. This new system allows for simple and timely reviews of required agreements to assure they are current and in accordance with changing health authority regulations.

PLASMA DONATIONS AND DONORS

CSL recognises that donors and their plasma donations are an integral part of helping keep our promise to patients who depend on the life-saving therapies derived from plasma. It goes without saying that if there were no or not enough donors willing to give their time and plasma, the quality of life of patients who depend on plasma-derived products would be negatively impacted.

For our donors, CSL Plasma has developed the most efficient processes and systems that focus on donor, plasma and staff safety along with donor satisfaction. By remaining focused on the safety and wellbeing of the donors, all efforts are made to ensure that a consistent positive donor experience is realised during the donation process. One example of how this is achieved is by having a manageable employee to donor ratio, which allows for the safe collection of plasma per local, national and international standards while ensuring the donor’s time is respected. In addition, CSL Plasma’s internal and external management hierarchy continuously monitor its safety and quality systems to maintain an environment of safety, professionalism and donor focus in compliance with industry standards along with local, state, federal and international regulations.

CSL Plasma prides itself on holding true to our promise to provide exemplary customer service to all our donors. For financial years 2013/14 through to 2015/16, 1.7 million surveys were completed by our donors of which 99.3% stated they would be willing to donate again and 96.1% stated they would be willing to refer a friend to donate at CSL Plasma. CSL Plasma understands the importance of every donor and the result of our exemplary customer service is shown in how many donors return to help save a life.

Plasma donor safety

Donation of source (human) plasma by plasmapheresis is a procedure with a proven safety record utilising current technology for automated collection. In addition, donors are carefully screened for health issues that could pose a safety issue for them during the procedure and are deferred if they have medical problems that could increase their likelihood of an adverse event as a result of donation. However, as with any procedure, adverse events do occasionally occur and are reported by donors. Our concern as a company and as individuals for the safety of the donation process mirrors our concern for the safety of our products for patients.

CSL Plasma employees vigilantly monitor plasma donations real-time. In the event of a donor adverse event resulting from the donation process, an immediate and appropriate response is initiated. In all cases a report of the event is recorded and the donor only discharged when completely recovered and given care instructions as appropriate for the event. A medical director at each centre reviews all reports, diagnoses the cause of the event, and indicates if and when the donor can resume donating plasma. Any donor who experiences an adverse event is encouraged to discuss it with CSL Plasma medical staff. If the donor is cleared to continue to donate, the donor would discuss with our staff how to prevent a repeat of the event. Examination of company-wide donor adverse event trends allows for continuous improvement in the management of plasma donors and the donor experience.