Friday, November 17, 2023
ACROBiosystems, a leading entity in the pharmaceutical industry dedicated to providing innovative tools and solutions, has recently introduced the GMP grade DLL4. This represents a recombinant, soluble form of Delta-like Ligand 4 (DLL4), and notably, it is one of the few products on the market manufactured under Good Manufacturing Practice (GMP) conditions.
The unveiling of DLL4 produced under GMP conditions is a significant stride for enterprises engaged in the development or manufacturing of stem-cell-based biologics. The GMP process ensures the consistency and contaminant-free nature of the DLL4 recombinant protein, making it a reliable raw material for stem cell culturing within a controlled environment.
Traditionally, feeder cells such as OP9-DLL4 are utilized to secrete DLL4 during the growth and differentiation of stem cells in vitro, creating a microenvironment that replicates the natural bone marrow niche. While these feeder cells have played a crucial role in stem cell research and therapy development, they are not without limitations. Concerns include the risk of pathogen contamination, complexities in regulatory approval due to variability, and challenges associated with large-scale production.
ACROBiosystems' GMP grade DLL4 is specifically designed for stem cell culturing in biologics manufacturing undergoing clinical trials. Serving as a safer and regulatory-compliant alternative to feeder cells, it facilitates a streamlined path towards commercialization by reducing the need for data revalidation during Investigational New Drug (IND) submissions.
ACROBiosystems, expressed pride in offering GMP-grade DLL4, highlighting the company's commitment to expediting biologics development and regulatory approval. The high-quality DLL4 recombinant protein acts as a feeder-cell alternative, enhancing safety and regulatory compliance for customers.
With over a decade of experience in developing recombinant proteins and growth factors, ACROBiosystems provides a comprehensive solution from research to commercialization. Stringent quality controls, a well-audited quality management system, and expert quality control specialists ensure high-purity, low-endotoxin, and batch-to-batch consistent growth factors, including DLL4. This approach goes beyond GMP, offering a wide range of high-quality research-grade growth factors to support research discovery and scale up to meet manufacturing needs.
GMP grade DLL4 is now available on ACROBiosystems' website and through its partner distributors, expanding accessibility to this crucial tool within the pharmaceutical industry.