CSL Ltd Annual Report 2020

The COVID-19 pandemic has underscored the importance of CSL’s ability to think globally and act locally to help ensure that we can continue to meet growing demand, fulfil the critical need for our lifesaving medicines and improve public health. Throughout the global health crisis, CSL has leveraged its reach and strategic manufacturing and distribution capability with a high degree of coordination, agility and flexibility to continue meeting the needs of patients and healthcare providers worldwide. Within our end-to-end operations organisation, we are focused on delivering top-tier results in safety, quality, reliability and innovation, and driving efficiency and scale of our operations to supply the expanding global market. Global reach and focus CSL applies its world-class research and development (R&D), commercial strength and patient-focused management, along with its high-quality manufacturing, to develop and deliver innovative biotherapies, influenza vaccines and support programs. In the past five years, CSL has grown rapidly, due to strategic acquisitions, a rise in global demand for our products and investment in increased capacity and modernisation. Our management team has significant experience in the industry and the confidence to drive our promise to patients into the next century. Our commitment to strategic sourcing has allowed the business to have a reliable supply of lifesaving therapies in multiple facilities across the globe. A number of CSL’s sites are supporting major capacity expansion projects fromProject Phoenix in Marburg, Germany, for base fractionation, Project Protinus in Bern, Switzerland, for PRIVIGEN ® , and Project Aurora in Broadmeadows, Australia, also for base fractionation. The timing of these projects coming online will help ensure a seamless supply of products to patients. Although the COVID-19 pandemic briefly slowed construction work on CSL’s state-of-the-art manufacturing facility in Lengnau, Switzerland, the site continues to move toward completion. In May 2020, CSL announced that we have entered into a strategic partnership with Thermo Fisher Scientific Inc. for the lease of the Lengnau facility. As part of this long-term lease agreement, Thermo Fisher will manufacture and supply CSL Behring with IDELVION ® , which will be produced in Lengnau. Thermo Fisher is scheduled to assume oversight and operation of the facility once construction is completed in mid-2021. When the Seqirus business was formed, there were 400 applications inherited from the legacy businesses. A major milestone was achieved in October 2019 with the three-year Edge program successfully completed, enabling Seqirus to be fully integrated globally on a single information systems platform. This is greatly enhancing collaboration and efficiency across the business. In a multiyear investment, the first serialisation of Seqirus products was supplied for the 2019/20 influenza season in the US and Europe. Serialisation is where a unique serial number is printed on each pack of vaccines. It helps to combat counterfeit products and provides the basis for full track and trace of our vaccines in the future. Seqirus’ Southern Hemisphere products are also now serialisation-capable. Seqirus has been able to simplify and streamline the testing process to release FLUCELVAX ® influenza vaccine into the US each season. Since 2012, the Food & Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) requirement to demonstrate that the influenza virus had been successfully inactivated in our cell-based vaccine was undertaken using egg-based testing. This required complex network logistics to ship a number of bulk lots of FLUCELVAX from the US to the Seqirus Liverpool site in the UK, for testing each year. Seqirus quality control teams collaborated over multiple years to prove that the cell-based testing was equivalent, or superior, to egg-based testing. With CBER agreement, the egg-based testing is no longer required. With testing now based at our Holly Springs plant in the US, the need for complex shipping is also removed, thereby reducing risk to the product. Seqirus introduced a new process for inspection of harvested allantoic fluid, at the influenza vaccine manufacturing site in Parkville, Australia. This process was designed in-house and has enabled the removal of the cumbersome process of ‘candling’ over 440,000 eggs per day. Seqirus Liverpool, UK, has optimised the process for incubation of eggs pre-inoculation that has resulted in yield improvement in certain strains of 15%. This year, Seqirus Liverpool saw the commissioning and start-up of a new line for production of MF59 ® , Seqirus’ novel adjuvant. The line is now operating and capable of producing over 1000L per week of bulk sterile MF59. Production of the Seqirus antivenom portfolio has been improved in the past year. The Therapeutic Goods Administration (TGA) approved the chemistry, manufacturing, control (CMC) regulatory variation for the use of an adjuvant in venom dosing. Use of this adjuvant has significantly increased antibody potency for most antivenoms. Donor management CSL Plasma, a division of CSL Behring, has grown to become one of the largest plasma collection networks in the world, providing human plasma to CSL Behring for the manufacture and distribution of plasma protein biotherapeutics. Expanded laboratory and logistics operations have increased CSL Plasma’s testing and storage capacity to meet the growing need for plasma-derived therapies. 99% of plasma donors are willing to donate again.* 97% of plasma donors are willing to refer a friend to a centre.* * Limited assurance by Ernst & Young. CSL Limited Annual Report 2020 32 8 Global Reach and Impact