Icelandic company Platome Biotechnology is reinventing cell culture to help speed up the development of approved cellular therapies.
Regenerative medicine will play a key role in the healthcare of the future and can generally be split into two different fields, one being tissue engineering, where engineering approaches and biomaterial sciences are used to construct an organ or a tissue, and the other being cellular therapies, where cells are infused into patients and then either directly or indirectly take part in regeneration. Both approaches have the potential to treat complex medical issues such as non-union fractures and severe graft versus host disease in the near future, while more complicated conditions (e.g. Alzheimer’s and Parkinson’s diseases) are further away.
The potential is great, but several issues need to be resolved before regenerative medicine enters common practice. One important issue that needs to be considered is how the cells used to treat are obtained and how they are handled prior to implantation into the patient. In order to obtain an effective treatment dose, the cells need to be expanded in the laboratory to reach high enough numbers, numbers that are clinically relevant. The expansion process should ideally take place under tightly regulated conditions to ensure quality and safety for the patient receiving the cells.
Are platelet lysates the solution?
For the past decades animal serum such as foetal bovine serum (FBS) has been essential for any cell culture, whether it is expansion or differentiation of cells. The use of animal serum to grow cells intended for medical treatment is strictly regulated. The strict regulations are due to potential health risks related to animal serum. Animal serum is also associated with high variability between production lots, and its availability is vulnerable to environmental factors. The use of FBS for cellular therapies is especially debated because it is frequently used and is associated with several drawbacks like potential transmission of xenogeneic viruses, proteins and antibodies that could have a detrimental effect on the recipient of the therapeutic cell product.
To solve this, scientists at Platome Biotechnology and other groups have been leading the way in finding alternatives to FBS that are safe for the clinical use of cell therapy products. The most promising alternative is platelet lysates created from expired platelet concentrates as a replacement for foetal bovine serum.
The problems linked to animal serum are costly, time-consuming and complicated. Animal-free options are needed, yet the development of such products has been problematic. Recent guidelines encourage the use of human-based alternatives such as the platelet lysates produced by Platome Biotechnology. Demand for such products has subsequently increased. The main trend is the increasing approval rate of cellular therapies, which is leading to the urgency of seeking specialised and complex ancillary materials that better suit this new scenario. Despite the fact that there is not yet a specific regulation, rather guidance on raw material use from national and international organisations – including the European Medicines Agency, the US Food and Drug Administration and the International Conference on Harmonisation – it is anticipated that regulations will be approved shortly, as happened with the gene therapy legislation in Europe.
Platome Biotechnology has the answer
Platome Biotechnology develops a range of solutions and products which solve the problems of animal serum. The products are used to supplement cell cultures instead of animal serum. They function as a direct replacement without affecting the cell culture methodology. All the products from Platome Biotechnology are made from expired platelets which are obtained from certified blood banks. Platelets from blood banks have passed vigorous quality control checks and are a valuable material. Blood banks, however, are forced to discard platelets regularly since the platelets have a short shelf life and expire only a few days after blood collection.
Platome Biotechnology has demonstrated that expired platelets can be used to fully support growing stem cells and has developed methods to turn this former waste into value. The products are biochemical solutions that are used as feedstock for cells in laboratories. They are environmentally friendly and support animal welfare since biological waste is reduced and no animals are harmed in the process. The aim is to make the development of cellular therapies both easier and safer. The platelet lysates are useful to all researchers and companies who work with stem cells, tissue engineering, biomaterials and therapy development, and help increase the safety and quality of their work.
Who are Platome Biotechnology?
Platome Biotechnology was founded in Iceland back in 2016 as a joint effort between Dr Sandra M Jónsdóttir-Buch and Professor Ólafur E Sigurjónsson, with the ambitious goal to make development of the growing field of cellular therapies both easier and safer. To succeed in such a task, they decided to reinvent how stem cells and other valuable human cells are grown in laboratories. Together they developed technology where processed human blood platelets are used to create a range of products and biochemical solutions that can be used as feedstock for cultured cells, fulfilling all their physiological requirements.
In a short period of time Platome Biotechnology has reached a rapid growth, expanded the team, and quickened the pace of product development. The company has been featured in international media, named as the Startup Company of the Year (2017) and attracted international awards.
Platome Biotechnology is based on several years of research in the laboratory of Sigurjónsson. When the group was awarded the Applied Science Award of the University of Iceland in 2014, Jónsdóttir-Buch and Sigurjónsson decided to found the company. Ms Helena Montazeri, a skilled biochemist, joined the team shortly after as the project manager. Jónsdóttir-Buch serves as the CEO and Sigurjónsson the CSO. Since then, Platome has been providing scientists with high-quality solutions to grow stem cells and tissues in laboratories without the use of animal serum.
The future of cell therapy development
From the beginning Platome Biotechnology has been creating knowledge, patents and products for the international market. Platome Biotechnology has several products in the pipeline – different variations of platelet lysates that serve different target groups. But the company will not stop at that.
After having developed the methodology to produce human platelet lysates, Platome Biotechnology now recognises how valuable this technology really is. The team is therefore now seeking ways to empower blood banks around the world to adopt the technology, allowing them to produce their own platelet lysates in an easy and manageable way.
To achieve this, Platome Biotechnology is already underway developing a complete easy-to-use closed system that will be available to all interested parties who wish to produce GMP human platelet lysates easily without having certified GMP facilities. This is in line with the original goal of the company founders to help make the development of cellular therapies easier and safer.
Dr Sandra Jónsdóttir-Buch, Helena Montazeri and Professor Olafur
Platome Líftækni ehf
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This article will appear in issue 7 of Health Europa Quarterly, which will be published in November 2018.