PEOPLE HELPING PEOPLE

The Plant

For Grifols, the journey from donor to patient consists of first extracting plasma from healthy donors and then providing effective, and above all, life-improving therapies to patients.

In the following sections you will find an overview of the essential steps on that often long and complex journey, and how we at Grifols leverage our expertise and passion to ensure it's as smooth and safe as humanly possible.

The right type of blood

Finding the right blood type for each recipient is one of the oldest challenges of hematology. From the very beginning, Grifols was at the forefront of blood typing, pioneering new techniques that make the process ever more accurate, rapid, and reliable.

We have designed extremely precise tools to identify and analyze blood, ensuring its suitability before transfusing it into a patient, and have worked for years to provide blood types in the shortest time.

Now, our serological, immunological, and NAT (Nucleic Acid Testing) protocols are trusted in hospitals and blood banks around the world to help ensure transfusion safety.

Donation of plasma: plasmapheresis

Plasma is the fluid component of blood that remains after the cells and platelets are extracted. Refining blood plasma and extracting and concentrating key proteins are central to our business and to the well-being of patients across the world.

Extracting plasma from a donor while allowing them to retain their blood cells and platelets is essential to large-scale production of plasma-based medicines that are vital to both our patients and our core business. And it was made possible thanks to another Grifols innovation: plasmapheresis.

Dating from 1951, the technique separates out the plasma for collection and re-transfuses the other cellular elements into the bloodstream of the donor.

Because plasma regenerates in the body much more quickly than whole blood, plasmapheresis allows us to safely gather more of the liquid, and extract more proteins. After plasmapheresis each and every unit of plasma is tracked to ensure the highest standards of quality and safety.

A lot has changed since we opened our first manufacturing plant in Parets del Vallès, near Barcelona, Spain, in 1972, but the essential principles of analysis, extraction, purification, and distribution remain the same, even if the scale and technology used has accelerated.

These days, we are the largest collector of human plasma on the planet. Over 45,000 annual donations are made at our 295 donation centers around the world, providing Grifols with a dependable supply of the plasma needed to produce our therapies.

At Grifols, we only accept donations from qualified donors to produce our medicines. The donors have to pass all our health checks and have never had any anomalies detected in previous donations. If donations come from centers other than our own, plasma units are reanalyzed according to our own, exacting standards.

Proteins: the source of health inside us

Medically speaking, the most important component of plasma is its proteins. They number in the thousands, and new ones are discovered daily. Over time, their roles in the human body are being revealed.

Plasma consists of 90 percent water and only 7 percent proteins, of which Grifols isolates and commercializes the following as they are industrially obtained:

  • Factor VIII and other clotting factors are mostly used to treat bleeding disorders such as hemophilia, von Willebrand disease and other conditions that may result in dangerous bleeding episodes
  • Fibrinogen is used in surgery as biological glue
  • Immunoglobulins are mostly used to treat problems of the immune system and chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological condition
  • Alpha-1 antitrypsin helps patients suffering from alpha-1 antitrypsin deficiency, a rare genetic condition that can lead to severe lung diseases, including emphysema
  • Antithrombin to treat hereditary antithrombin deficiency, a rare thrombophilia that can lead to thrombotic conditions
  • Albumin was one of the first plasma proteins to be used therapeutically. It can restore circulating blood volume and protein loss for patients suffering from conditions as diverse as liver cirrhosis, trauma, cardio-circulatory insufficiency, or severe burns. Currently, Grifols is leading research to assess its potential to treat Alzheimer's

Plasma fractionation: putting complexity in order

The route to obtaining a pure, individual protein that can be used therapeutically consists of a series of distinct steps. Step one is called plasma fractionation, and is the separation of different proteins from one another.

The process was first developed by the biochemist Dr. Edwin Joseph Cohn and takes raw plasma and successively applies different adjustments of temperature, pH, and alcohol concentration until the desired proteins precipitate and are isolated.

Once we have the proteins we need, the next step is to maximize their purity in order to concentrate their value to the patient. Currently, the number of plasma proteins that are used medically is limited to around ten. As more therapeutic possibilities are discovered, we will continue to be at the forefront of using plasma proteins to enhance the well-being of patients, looking for new treatments to improve lives around the world.

Purifying proteins: uncovering the essence

The purer the protein, the more effective its therapeutic benefits for the patient. Which means that maximizing purity is an essential step in the process of providing the medicines which will transform lives.

At the same time, we take the greatest care to include steps in our manufacturing processes with the capacity to inactivate potentially dangerous agents and filter out impurities in an effort to eliminate any threat to patients' well-being.

Experience has taught us that where patient health is concerned, it may be relevant to comply with additional standards to those required by the applicable regulations. Ours must become the model to follow, and it's a source of pride that we are experts in our field.

Filling vials: the critical moment

Once the product is purified, the next challenge is to ensure sterile filling of the final products.

To do so, the protein must be protected from the external environment, essentially locking it away from the outside world. Filling without contamination is the next critical step in the journey from donor to patient.

As part of our commitment to continual innovation, we have developed our own system for ensuring the most aseptic condition possible during the filling process.

A passion for safety keeps track of products

As our products approach their final destination, they also come closer to connecting the lives of the original donor with those of the eventual patients. When they leave our plants, we need to be sure that connection will be a success, properly tracked and traced.

Keeping an extensive, in-depth record of the entire life history of each product helps ensure that traceability, and thus the well-being of patients. The link between Grifols and its medicines remains intact even after they leave our facilities, and it's called the PediGri® program.

This sophisticated software tracks all products and contains all product-related information, making it available and transparent to healthcare professionals and helping to maintain our global and steadfast commitment to transforming and improving the lives of patients everywhere.

The hospital pharmacist: a customer and an ally

Our relationship with hospitals began with providing intravenous solutions, but today we also add value through other scientific advances and our innovative, integrated hospital pharmacy solutions.

We were pioneers in the use of information technology applied to hospital pharmacies, and even designed computers and software that responded to their specific needs.

The scope of our alliance with hospitals has been expanding over recent years with the advent of new solutions for clinical nutrition, hospital logistics, and compounding. Our fundamental goal, however, has been and is always the same: to make life easier for those responsible for their pharmacies.

It's all about the patients

As a company, our motivation is not the manufacture of products, but a mission to transform lives. Much of our focus is on rare diseases such as primary immunodeficiency, alpha-1 antitrypsin deficiency, bleeding disorders, and chronic inflammatory demyelinating polyneuropathy.

Our mission is to turn donors' generosity into better lives for patients around the world.