With the rapid development of novel biological products such as cell therapy products, the demand for the production of raw materials is constantly increasing. Among them, the performance, quality, consistency and safety of raw materials for cell culture have increasingly become the focus of the industry.
ACROBiosystems has developed more than 5,000 recombinant protein products and accumulated more than 10 years of protein development and manufacturing experience. To better meet the needs of cell therapy products development stages and applications, and to comprehensively accelerate research and development process, ACROBiosystems has launched its custom GMP-grade protein services.
ACROBiosystems strictly complies with regulations of cell therapy raw materials and excipients, relying on GMP facilities, through advanced protein expression technology and comprehensive quality management system and quality controls, to ensure the consistency between batches, while the full process of strict control of virus, mycoplasma, bacteria, endotoxin and other external factors pollution, to meet the regulatory requirements. Each step is automated or performed under sterile conditions to minimize external contamination risks. Production and purification procedures use equipment and media that are confirmed to be animal-free.
To facilitate a seamless transition from preclinical development to clinical phase,ACROBiosystems offers two different developmental processes: converting their non-GMP protein products to GMP or developing a custom GMP-grade protein product from scratch. GMP-grade protein products use the same clone, sequence, and expression system as their non-GMP grade proteins and have the same performance. Customer can use non-GMP proteins (Premium or RUO reagents) to save time, costs,
and meet deadlines. When transition into later clinical phases, ACROBiosystems’ products are ready to scale-up and match your demands through clinical research and beyond. ACROBiosystems can also provide customized development services from scratch and ensure that its products are both structurally designed and validated for cellular therapies manufacturing. Different expression systems, purification methods, and protein tags/labels can be selected to maximize therapy’s success.
Through the custom GMP-grade protein services, ACROBiosystems seeks to provide high-quality raw materials without disrupting customers’ development process and comprehensive support for clinical trials.
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