Human plasma-derived therapies (PDTs) play a vital role in modern medicine and have long offered life-saving treatments for millions worldwide. Created from the liquid portion of human blood, which contains essential proteins and antibodies, these therapies are crucial for treating a variety of medical conditions, particularly those involving immune deficiencies, bleeding disorders, and autoimmune diseases.
Recent advances are transforming and expanding the treatment landscape for additional conditions. For example, Immunoglobulin (IgG) products, which have traditionally been used for immune deficiencies, are now finding broader applications in neurology, oncology, and autoimmune diseases. Trials are also looking into new possibilities, such as the use of human albumin in organ transplantation and plasma-derived hyperimmune globulin for infectious diseases.
At VILS, we understand that the faster your discoveries can be applied, the faster they can start improving – and in some cases saving – people’s lives. We share your passion for your work because it matters to us.
On the other hand, your business needs may lead you to delay investments until more solid scientific data are available, followed by an accelerated path to operational readiness. Either way, VILS known for delivering solutions quickly to launch when the timing is right.
New production methods
In addition to expanding the therapeutic scope of PDTs, manufacturers are making innovations in their manufacturing processes. One way is by exploring alternatives to traditional ethanol fractionation, which has been a cornerstone of plasma protein separation since the 1940s. Newer methods aim to enhance efficiency, safety, and sustainability, with automation and advanced centrifuge technologies potentially reducing reliance on manual operations.
The VILS approach to designing facilities is highly pragmatic, based on years of experience working with researchers whose discoveries are making an impact on human health today. We start with a thorough understanding of your process and the next step in your business plan, instead of with a preexisting design that is modified to fit. VILS’ deep process knowledge and focus on the essential allows us to rapidly design efficient facilities for existing and breakthrough using cutting-edge technologies.
For example, as the plasma therapy industry moves away from traditional cold ethanol fractionation, which has limitations in efficiency and environmental impact, VILS’ process knowledge will allow it to design facilities with more modern solutions.
One of these is EBA (Expanded Bed Adsorption) chromatography, a safer and more efficient plasma protein purification method. By applying EBA or adapting similar innovative technologies, VILS can improve protein yield and quality while reducing costs.
Complex treatments, complex regulations
As cutting-edge therapies develop, researchers creating human plasma-derived therapies face a rigorous regulatory environment. This reflects the complex nature of these treatments and their reliance on human-derived biological materials. Compliance with Good Manufacturing Practices (GMP) is mandatory. This ensures proper handling, processing, and quality control of plasma to prevent contamination and maintain product efficacy.
Developers must also adhere to standards set by agencies like the World Health Organization (WHO). Organizations such as the Plasma Protein Therapeutics Association (PPTA), which provide guidelines on plasma collection, testing, and processing to ensure safety. Modern challenges, like pandemics and the need for rapid vaccine development, also drive adaptations in regulatory frameworks.
Experience with stringent regulations
VILS, which has worked with a number of companies on the cutting edge of biotechnology, has experience handling exactly this type of stringent regulatory environment. The same focus on the process that has resulted in lean, efficient facilities has also resulted in facilities that meet GMP and other requirements for approval.
By combining our expertise in efficiency, innovation, pharmaceutical production, and regulatory compliance with the work of innovative scientists conducting breakthrough research, VILS will enhance production capacity and therapeutic development in human plasma-derived therapies.