As a global leader in the plasma protein biotherapeutics industry, CSL Behring is passionate about safety and quality.
For over 30 years, CSL Behring has performed Toll Manufacturing on behalf of National Blood Services, Health Authorities and
Red Cross Organizations in the United States and Europe. Through these collaborations, locally collected plasma is sent to a CSL Behring fractionation facility in Switzerland, Germany, or the U.S., fractionated into several therapeutic plasma products, and then returned to the customer.
Toll Manufacturing Quality & Safety
CSL Behring is committed to producing high-quality, safe and effective biotherapeutics to improve the quality of life for people with rare and serious diseases and to advance treatments worldwide. The company is dedicated to meeting or exceeding the most stringent national and international standards for plasma product safety in accordance with regulatory agencies worldwide. CSL Behring’s dedication to collecting safe plasma and manufacturing products of the highest quality is well known within the industry and patient community.
Today, CSL Behring products provide their highest level of safety ever, due to substantial investment in product safety, manufacturing facility enhancements, and research and development activities. CSL Behring biotherapeutics are manufactured in state-of-the-art facilities under stringent, controlled conditions, with each step of the manufacturing process enhancing product safety.
The elimination and inactivation of viruses in the manufacturing process of plasma products is achieved via several steps. It starts with the selection of donors and testing of donations, proceeds with purification, virus inactivation and elimination, and is completed by multiple levels of quality control and screening.
CSL Behring currently performs Toll Manufacturing on behalf of:
Canada: Following a tender process, CSL Behring signed an agreement in 2008 with
Canadian Blood Services to fractionate Canadian plasma. The agreement, which covers a five-year period with two one-year extension options, included a Development Plan for the licensing of Canadian plasma for CSL Behring’s products. Licensing by
Health Canada was successfully achieved in early 2009, allowing for regular fractionation of Canadian plasma at CSL Behring’s plant in Bern.
CSL Behring Canada
Denmark: Since 2004, CSL Behring has been the Toll Manufacturing partner for the Danish Regions. In 2008, the Danish Regions tendered the Toll Manufacturing contract for a new six-year term. Successful in this tender, CSL Behring is proud to collaborate with the Danish Regions, Hospitals, and Blood Centers for another six years.
CSL Behring Denmark
By entering into a Toll Manufacturing collaboration with CSL Behring, customers increase sufficiency, without the complex, costly process of establishing a local fractionation plant. CSL Behring partners benefit from economies of scale possible through large-scale manufacturing, as well as CSL Behring’s heritage of quality and safety.
For more Toll Manufacturing information
here to submit an inquiry.