ACROBiosystems, a pivotal player in the pharmaceutical industry, recently announced the launch of its GMP grade DLL4, a significant advancement in the field of stem cell research and biologics manufacturing.
DLL4, or Delta-like Ligand 4, is a recombinant, soluble protein now available in a GMP (Good Manufacturing Practice) compliant form. This launch marks a considerable milestone, offering a consistent, contaminant-free product, essential for stem cell culturing in a controlled environment.
Traditionally, stem cell culturing involved the use of feeder cells like OP9-DLL4, which replicate the bone marrow niche, aiding in stem cell growth and differentiation. However, these animal-derived feeder cells pose risks of pathogen contamination and complicate regulatory approval due to variability in the final cell product. Additionally, they are not ideal for large-scale production and their removal from the final product can be technically challenging.
The introduction of ACROBiosystems’ GMP grade DLL4 addresses these challenges. It provides a safer, regulatory-compliant alternative to feeder cells, supporting the streamlined path towards commercialization of biologics.
This development is particularly crucial for manufacturing biologics undergoing clinical trials, as it minimizes data revalidation during Investigational New Drug (IND) submissions.
Qian Liu, Senior Quality Assurance Manager at ACROBiosystems, emphasized the company’s commitment to accelerating biologics development and regulatory approval through this high-quality, GMP-grade DLL4 recombinant protein. The product is designed to aid customers in overcoming the limitations of traditional feeder cells, ensuring safety and compliance with regulations.
ACROBiosystems, with over a decade of experience in developing recombinant proteins, boasts strict quality controls, an audited quality management system, and skilled quality control specialists. This ensures the delivery of high-purity, low-endotoxin, and consistent batch-to-batch growth factors, including DLL4, alongside comprehensive regulatory documentation.
GMP grade DLL4 is now available through ACROBiosystems’ website and partner distributors. ACROBiosystems Group, established in 2010 and listed in 2021, operates globally with offices, R&D centers, and production bases across the United States, Switzerland, England, and Germany. The company has forged strong partnerships with leading pharmaceutical enterprises and academic institutes, reflecting its influential role in the biopharmaceutical and health industries.