NEWARK, Del., Nov. 16, 2023 /PRNewswire/ — ACROBiosystems, a global cornerstone of the pharmaceutical industry committed to offering innovative tools and solutions, recently announces the launch of GMP grade DLL4. GMP grade DLL4 is a recombinant, soluble form of Delta-like Ligand 4, or DLL4, that is one of the few products available on the market manufactured under GMP conditions.
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 guarantees 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 the natural bone marrow niche that allows for stem cells to thrive and differentiate. As such, these feeder cells are often utilized to stem cell research and 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.
Because our 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," says 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."
Leveraging over a decade-long experience in developing recombinant proteins and relevant growth factors, ACROBiosystems is poised to offer a complete solution from research to commercialization. Strict quality controls, an extensively audited quality management system, and professional quality control specialists all contribute to ensuring high-purity, low-endotoxin, batch-to-batch consistent growth factors, including DLL4, alongside a comprehensive set of regulatory documentation. This extends beyond GMP and a wide offering of high-quality research-grade growth factors to assist with research discovery, and scale-up to match customers’ manufacturing needs.
GMP grade DLL4 is now available on ACROBiosystems’ website and its partner distributors.
ACROBiosystems Group (SZ.301080), founded in 2010 and listed in 2021, is a biotechnology company aimed at being a cornerstone of the global biopharmaceutical and health industries by providing products and business models innovation. The company spans across the globe and maintains offices, R&D centers, and production bases in 12 different cities within the United States, Switzerland, England and Germany. ACROBiosystems Group has established numerous long-term and stable partnerships with the world’s top pharmaceutical enterprises, including Pfizer, Novartis, and Johnson & Johnson, and numerous well-known academic institutes. The company comprises of several subsidiaries such as ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.