Key Takeaways
- PL BioScience and DewCell are collaborating to develop a synthetic, animal-free human platelet lysate, addressing the growing demand for ethical and standardized cell culture media.
- This partnership supports global regulatory momentum—led by FDA, EMA, and WHO—toward eliminating animal-derived materials in drug development and manufacturing.
- New USP guidelines and advances like recombinant endotoxin testing signal a broader industry shift toward scalable, animal-free bioprocessing solutions.
German life sciences company PL BioScience and Korean biotech company DewCell Biotherapeutics have signed a letter of intent (LOI) for the supply of artificial platelet raw material, an agreement under the terms of which DewCell will provide batches of artificial platelets for PL BioScience’s human platelet lysate solution for cell expansion (1).
The LOI follows a memorandum of understanding, signed on March 27, 2025, laying the groundwork for collaboration between PL BioScience and DewCell to develop the world’s first artificial platelet lysate (1).
In a press release on May 19, 2025, PL BioScience said its ability to meet global demand for high-quality, animal-free cell culture media would be strengthened by the partnership (1). DewCell’s process of making the artificial platelets involves differentiating stem cells into megakaryocytes, then optimizing them for scalable production.
“By combining DewCell’s pioneering artificial platelet technology with PL BioScience’s advanced manufacturing expertise, we aim to deliver a high-performance synthetic, animal-free culture medium that sets a new standard in the industry,” said Jungsoo Park, vice-president, Marketing and Sales, PL BioScience, in the release (1). “This collaboration represents a significant step toward replacing conventional, animal-derived products.”
Global organizations go animal-free
According to PL BioScience, FDA, the European Medicines Agency, the World Health Organization, and the Pharmaceutical and Medical Devices Agency of Japan are among the global regulatory bodies driving a shift to animal-origin-free solutions in cell therapy and manufacturing, to enhance safety, standardize quality, and satisfy ethical considerations (1). In April 2025, FDA said it would be taking steps to replace animal testing in development of monoclonal antibody therapies and other drugs with “human-relevant” methods the agency said are more effective (2).
Usage of platelet lysate with a high concentration of growth factors from human platelets is an expanding technique that is gaining more attention in the field of cell-based pharmaceuticals, PL BioScience said (1).
“This LOI demonstrates the industrial potential of artificial platelet technology,” Minwoo Lee, CEO of DewCell Biotherapeutics, said in the PL BioScience release (1). “Our goal is to move beyond research applications and expand into GMP-compliant manufacturing and clinical use.”
New regulatory guidelines
In the November 2024 episode of Pharmaceutical Technology® Group’s Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discussed the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, published that month by the United States Pharmacopeia–National Formulary (3). The chapter permits the use of non-animal-derived reagents for endotoxin testing and is part of USP’s commitment to expanding the use of animal-free methods and materials.
“Twenty years ago, the predominant test procedure for determining endotoxin level, or pyrogen level, as we called it, was the rabbit test,” Schniepp said in the video feature. “And we used to actually inject rabbits, which was very subjective because you'd measure their temperature ... And then we evolved to using the limulus amoebocyte lysate or LAL test, and there was the chromogenic [test] but they were all predicated off the horseshoe crab. So now we're moving forward to reagents for this test, which is critical to the release of sterile injectables that does not involve animals. So absolutely, we should consider this.”
View the full Ask the Expert video with Schniepp and Schmitt’s commentary!
References
1. PL BioScience. PL BioScience and DewCell sign LOI to Jointly Develop Artificial Human Platelets for Scalable, Animal-Free Cell Culture Media. Press Release. May 19, 2025.
2. FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. Press Release. April 10, 2025.
3. Thomas, F. and Haigney, S. Non-Animal-Derived Reagents for Endotoxin Testing. BioPharmInternational.com, Nov. 27, 2024.
