CSL Advances Plasma Manufacturing Technology
Synopsis
Clinical trials will support regulatory approval for a new process that increases immunoglobulin yields from donated plasma.
CSL has launched clinical trials of its Horizon 2 plasma manufacturing technology, advancing a new manufacturing process that will help enable higher yields of immunoglobulins from donated plasma.
The study will compare the safety, quality and efficacy of the immunoglobulin produced in the Horizon 2 process with that produced by CSL's current commercial process prior to gaining approval.
The clinical program conforms to the regulatory approval process needed to initiate human clinical testing after changes in the manufacturing of plasma-derived biological medicines. The regulators need to know that medicines made in a new manufacturing process are the same as those that have been approved.
The immunoglobulins are made from donated human plasma and are used in the treatment of primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy (CIDP) and a few other immune-related diseases, including multifocal motor neuropathy. Access to specialist care and the growing number of treatment indications has contributed to a rise in global demand over the last decade.
Plasma Supply Remains Central to Industry Growth
The Horizon 2 process aims to make the manufacturing of the same amount of immunoglobulin more efficient by using fewer donated plasma volumes without compromising the product's standards, CSL said. As the demand for plasma-derived medicines grows at a faster rate than plasma collections in certain markets, improving plasma utilisation is emerging as an industry priority.
The Marketing Research Bureau's Albumin & Immunoglobulin Market Report 2025 says the North American region is the largest market for immunoglobulin therapies with the world's largest plasma collection network.
Europe is the second biggest market whereas Asia-Pacific is the fastest-growing region due to the continued rise in the healthcare spending and diagnosis rates.
CSL has over 330 plasma collection centres, mostly in the U.S., servicing manufacturing plants in Australia, the U.S., Germany, Switzerland and the U.K. The company sells plasma-derived therapies, vaccines and specialty medicines in over 100 countries.
In FY2025, CSL's revenue was US$15.6 billion, an increase of 9% excluding the impact of currency conversions, and its net profit after tax attributable to shareholders was US$2.1 billion. The sales of its plasma therapies business rose by 20% and 34% respectively for Privigen and Hizentra, respectively, reflecting the continued demand for immunoglobulin products.
The results will support future regulatory submission of the updated manufacturing process if the Horizon 2 clinical study shows similar clinical performance.
Source: Reuters
Pooja Malik is a business journalist with over six years of experience covering startups, entrepreneurship, and emerging trends. She has previously worked with leading media platforms such as YourStory Media and BW BusinessWorld, where she reported on business, policy, and market developments. Currently, she serves as Editor at The Inspirepreneur Magazine, where she writes and edits stories across business, lifestyle, and travel, with a focus on clarity, accuracy, and reader relevance.
