Fujifilm Wako Pure Chemical Corp. launches MassivEVTM products for mass purification of extracellular vesicles; products promise high efficiency and purity to support exosome research and potential applications in healthcare, cosmetics, and food R&D

FUJIFILM Wako Pure Chemical Corporation (President: Koichi Yoshida) today announced the launch of the MassivEV^TM EV Purification Column PS and MassivEV^TM Purification Buffer Set, products designed for high-purity and high-efficiency mass purification of extracellular vesicles (EVs) to support exosome research.

EVs are lipid bilayer-delimited vesicles released by cells containing a variety of physiological active substances including lipids, nucleic acids, and proteins involved in intercellular communication that play a role in disease and health¹. EVs secreted by mesenchymal stem cells are reported to have a therapeutic effect on various diseases and skin conditions², prompting active R&D in the areas of healthcare, cosmetics, and food. In the medical field, there is a growing need for mass purification of high-quality EVs for application in diagnostic and drug delivery pharmaceutical manufacturing processes.

The MassivEV EV Purification Column PS and the MassivEV Purification Buffer Set are capable of EV purification from liter-scale cell culture supernatants compatible with safety and pharmacological testing. The products are based on the PS Affinity method³, FUJIFILM Wako Pure Chemical’s proprietary EV isolation technique, developed by Professor Rikinari Hanayama of Kanazawa University. The MassivEV products can achieve efficient single-step purification of EVs in higher purity than those obtained with the conventional mass EV purification method⁴, which requires multiple purification steps⁵.

FUJIFILM Wako Pure Chemical is working to achieve compliance with the Standards for Biological Ingredients⁶ and ISO20399⁷ and promoting further process development for future applications in commercial-scale manufacturing.

With commitment to the future of science and dedication to creating happiness, FUJIFILM Wako Pure Chemical will continue to develop and supply high-quality products that cater to the needs of our society and customers, and contributing to the advancement of academic research, industries and healthcare.

The new MassivEV products are currently available in the U.S. market.

¹Wang X et al. 2023. Cancer Gene Ther 30(8):1051-1065, PMID: 37106070.
²Kee LT et al. 2022. Int J Mol Sci 23(12):6742, PMID: 35743181.
³Method that uses Affinity purification method that leverages the biological interaction between specific molecules to selectively supplement and separate target molecules. The PS Affinity method targets Tim4 (T-cell immunoglobulin domain and mucin domain-containing protein 4), a protein which specifically binds phosphatidylserine (PS) present on the surface of EVs. Tim4 binds to PS in a calcium ion-dependent manner, allowing for EV capture on Tim4-coated magnetic beads in the presence of calcium ions, followed by elimination of contaminants and subsequent release of high-purity, intact EVs via a chelating reagent. (Yoshida and Hanayama. 2022. Methods Mol Biol 2466:23-36, PMID: 35585308).
⁴Conventional mass EV purification methods combine filtration-based Tangential Flow Filtration (TFF), Anion-Exchange Chromatography (AEX), and Size Exclusion Chromatography (SEC) steps.
⁵Per Fujifilm data obtained in November 2023
⁶Japanese Ministry of Health, Labor and Welfare Ordinance on Good Clinical Practice for Drugs item 37, setting out requirements for pharmaceutical manufacturing (including those used in manufacturing processes as additives, culture medium, etc) using materials derived from human and other lifeforms (excluding plants).
⁷International specifications defined by the International Standardization Organization (ISO) concerning ancillary materials present during the production of cellular therapeutic products.