Product and Process Development

Non-DEHP alternatives for blood bag systems

One of PPO’s major research lines is the search for alternatives to di(2-ethylhexyl)phthalate (DEHP) plasticizers in blood bag systems. DEHP is a phthalate compound that renders blood bags malleable and stabilizes red cell membranes. In line with European regulatory decisions, the use of DEHP in medical devices, including blood collection and storage systems, will no longer be permitted after 2030. This regulatory shift requires the blood transfusion field to identify and validate novel, safe, and effective plasticizer alternatives that maintain or improve red cell storage quality. PPO is therefore investigating a range of new materials and plasticizers, evaluating their impact on red blood cell integrity, hemolysis rates, and metabolic stability during storage, while ensuring full compliance with future legislative requirements.

Red cell concentrate from cord blood for premature neonates

Another innovative focus of PPO is the development of a specialized red blood cell concentrate derived from cord blood, intended for use in premature neonates. Premature infants frequently require transfusion support, and conventional adult red blood cell products may not fully meet their physiological needs. In particular, the high levels of adult hemoglobin and the different oxygen dissociation characteristics may contribute to complications such as retinopathy of prematurity, a serious condition that can cause lifelong visual impairment. Cord blood, by contrast, is rich in fetal hemoglobin, which has distinct oxygen transport properties better suited to the physiology of the premature neonate. By developing a standardized cord blood–derived red cell concentrate, PPO aims to offer a tailored transfusion product that could improve outcomes and reduce the risk of retinopathy of prematurity in pre-term infants. Ongoing studies focus on the processing, quality control and clinical evaluation of this product, as well as its potential integration into neonatal transfusion practice.

Human platelet lysate as a xeno-free alternative to FBS

PPO is, in an international collaborative, advancing the production of human platelet lysate (hPL) as an alternative to fetal bovine serum (FBS) for use in cell culture systems. FBS has traditionally been used as a supplement in cell expansion protocols, but its animal origin poses risks of xenogeneic contamination, immunological reactions, and batch variability. Furthermore, ethical concerns and regulatory pressure increasingly demand the transition to xeno-free culture systems, particularly for advanced therapy medicinal products (ATMPs). Human platelet lysate, derived from expired or surplus platelet concentrates, provides a rich source of growth factors that support robust cell proliferation. PPO’s research is directed at standardizing hPL production methods, ensuring pathogen safety, and optimizing its use across a broad range of cellular therapies. By developing hPL as a validated and safe supplement, PPO contributes to the establishment of more reliable, ethical, and clinically acceptable cell culture practices.

Development of allogeneic serum eye drops

Serum eye drops (SEDs) are used to treat patients with extreme dry eyes and other corneal defects. Serum is used in severe ophthalmic cases where conventional eye drops (artificial tears) have insufficient effect. The use of SEDs in dry eye patients usually has a rapid effect. Most patients claim the effect to be instantaneous, and all symptoms improve within 48 hours. There is evidence suggesting that substances in serum may help in the healing of epithelial defects, such as epidermal growth factor, fibroblast growth factor, fibronectin, and/or vitamin A. However, the precise serum factor responsible for alleviating the patient’s complaints is currently not known.

Commonly, autologous SEDs are used, but they are replaced more and more by allogeneic SEDs prepared from donor serum. Preparing autologous SEDs is often problematic due to patient-related problems and hospitals are not always equipped to produce these products under GMP conditions. The use of allogeneic SEDs will solve these problems. Allogeneic SED are derived from healthy voluntary, non-remunerated male donors with blood group AB, produced under blood bank GMP conditions, providing a safer product in larger quantities that is quickly available for each patient.

Within the project several characteristics of the SED are studied to learn more about the working mechanism. Changes are studied in relation to processing and storage time, like in growth factor content and ability to support corneal cell lines recovery after external damage by scratching. In the co-development with muDrop an innovative applicator will be used to pack the serum, allowing single use without too much waste of valuable serum.