ACROBiosystems launched GMP grade DLL4, a recombinant, soluble form of Delta-like Ligand 4, or DLL4, one of the few products available on the market manufactured under GMP conditions, according to the company.

In a statement, the company said that the availability of DLL4 manufactured under GMP conditions represents a significant milestone for enterprises engaged in developing or manufacturing stem-cell based biologics. The GMP process is designed to guarantee that the DLL4 recombinant protein is consistent, contaminant-free, and developed in a controlled production environment for use as a raw material in stem cell culturing.

Conventionally, feeder cells such as OP9-DLL4 are employed to secrete DLL4 during the growth and differentiation of stem cells in vitro. They provide a microenvironment that mimics natural bone marrow that allows for stem cells to thrive and differentiate. As such, these feeder cells are often utilized in stem cell research and to develop potential therapies.

However, the same feeder cells traditionally used in research and development come with notable limitations. The risk of contamination with pathogens, such as viruses or mycoplasma, is a significant concern when using animal-derived feeder cells, which can compromise the safety of therapeutic products. Second, the use of feeder cells complicates the regulatory approval process, as their presence can introduce variability and uncertainty in the final cell product. Lastly, feeder cells may not be suitable for large-scale production, and their removal from the final product can be technically challenging.

ACROBioSystems said that because its GMP grade DLL4 was designed for use in stem cell culturing for biologics- manufacturing undergoing clinical trials and as a complementary partner to our research and premium-grade DLL4, it supports a streamlined path towards commercialization by minimizing data revalidation during IND submissions.

“We are proud to finally offer DLL4 produced under GMP,” said Qian Liu, senior quality assurance manager. “This marks our commitment to helping accelerate biologics development and regulatory approval for our customers. By creating a high-quality, GMP-grade DLL4 recombinant protein, we are helping customers succeed by providing feeder-cell alternatives that are safer and regulatory-compliant.”