APPLICATIONS
The blood plasma fractionation process is becoming more and more important in the pharmaceutical and biotech industry in the last years. Plasma is a liquid component of blood that holds the blood cells of whole blood in suspension, carries cells and proteins throughout the body and is mostly composed of water (up to 95% by volume) but contains important dissolved proteins (6–8%).
The proteins derived from the fractionation process, such as immunoglobulins, albumin, clotting factors, gammaglobulins, are part of a recent and important narrative in the healthcare and scientific discussion, and they are used to treat several chronic and life-threatening diseases through several applications. The products of this process then can be transformed into vaccines, recombinants, monoclonal antibodies, hormones, antibiotics and other pharmaceuticals.
BLOOD THAWING
Blood plasma fractionation is a difficult process, which considers safety as well as efficiency, as it involves treating human blood, a precious and delicate resource.
The manufacture of plasma proteins is characterized by high capital costs, complex manufacturing processes, and a considerable regulatory burden. The economic and regulatory pressures require that high-quality manufacturing facilities be designed and maintained. The collection of plasma for specific clinical use and for plasma fractionation is a logistically and technically complex activity because of the need to ensure product safety and quality.
Plasma for fractionation should be stored at or below -20 Celsius and storage temperatures must be maintained during transport and processing. The most crucial step within the plasma fractionation process is thawing, which basically transforms the frozen plasma into melted plasma at 0 - 5,0°. Then, the liquid plasma is pumped to a pooling vessel for subsequent fractionation phases.
Different critical aspects have to be considered for this process: Olsa's new ThawMX® is designed to meet all optimal requirements.
- It’s essential to prevent the deterioration of the quality of the proteins. Innovative design functional to melt the raw material faster to preserve its quality.
- The amount of frozen blood that can be fed into the system per unit of time. Maximum efficiency with a strategic design: heat-transfer surface per total volume of the tank is maximized.
- The operators must be protected from exposure to the raw material at all times. Closed system to prevent any risk of exposure to the raw material.
- Avoiding contamination of the raw material by external agents anc cross-contamination between production batches is key. Closed system, highly-efficient CIP system and traceability of all batches.
EFFICIENCY
From the first experiences with the ThawMX and due to the changes in design, Olsa was able to grant a +150-200% efficiency compared to conventional batch thawing systems and +25-40% efficiency compared to other continuous thawing systems, guaranteeing in the meantime a higher standard of pharmaceutical level in terms of cleanability and cGMP execution.
RESULTS
Thanks to its renewed design, Olsa's ThawMX is the optimal solution if in need for a safe, efficient and simple system for thawing to integrate into a plasma fractionation process.
The raw material thaw rate has been more than doubled compared to vessels of same gross volume, thanks to increased heating surface and two additional ports. The closed-system design drastically reduced the possibility of external contamination, while also granting a greater operator safety, and the CIP and traceability eliminated the possibility of cross-contamination between batches. The mixer allows for easier maintenance and cleaning operations, due to its configuration and the cover lifting device.
SUCCESS STORY
Olsa, with more than 70 years of experience in the field, thousands of systems supplied all over the world to the main Biopharmaceutical and Cosmetic industries, has the competence and the capability to be the best and most reliable partner in the development, design, manufacturing and validation of complete systems for processing any product, and to support the customer also in the newest production challenges. Our equipment guarantees compliance with international and local requirements andregulations and allows complete integration into the customer process system.
PROJECT DEVELOPMENT
In 2020 Olsa had the opportunity to develop an innovative design for a thawing vessel implementing a wide range of improvements compared with a traditional unit in relation to all the crucial aspects of the blood thawing process.
All the projects start with the process design, drawings and 3D design of the systems to be installed, to evaluate with the customers all relevant variable parameters.
In this case, after data collection and an extensive R&D process, Olsa engineered and developed the ThawMX®.
Fundamental was the extensive experience in the production processes of pharmaceuticals and cosmetics and on the knowledge of the complete plasma fractionating process and the high-quality standards it is subject to, having designed, implemented and manufactured several fractionating systems for leading pharmaceutical companies worldwide. Thanks to a progressive and effective process of testing and improving, Olsa’s engineering expertise met or exceeded the project objectives.
WHATEVER THE APPLICATION, WE HAVE THE SOLUTION - OLSA
