With the rapid development of novel biological products such as cell therapy products, the demand for the production of raw materials is constantly on the rise. Among them, the quality, performance, consistency and safety of raw materials for cell culture have increasingly become an industry focus.
Image Credit: ACROBiosystems
With more than ten years of experience in developing and manufacturing proteins, ACROBiosystems has developed more than 5,000 recombinant protein products.
To better meet the needs of cell therapy products' development stages and applications and to comprehensively accelerate the research and development process, ACROBiosystems has launched its custom GMP-grade protein services.
ACROBiosystems strictly complies with regulations surrounding cell therapy raw materials and excipients, relying on GMP facilities through advanced protein expression technology and comprehensive quality management system and quality controls.
This is done to ensure consistency between batches and to completely control the contamination caused by viruses, mycoplasma, bacteria, endotoxins, and other external factors.
To minimize the risk of external contamination, each stage is automated or executed in a sterile environment. Equipment and media used in production and purification processes have been verified to be animal-free.
ACROBiosystems offers two distinct developmental procedures to enable a smooth transition from the preclinical to the clinical phase: converting their non-GMP protein products to GMP or creating a unique, GMP-grade protein product from scratch.
GMP-grade protein products perform similarly to their non-GMP-grade protein counterpart and employ the same clone, sequence, and expression method. Users can save time and money and meet deadlines by using non-GMP proteins (Premium or RUO reagents).
Moving further down the clinical phases, the products from ACROBiosystems are prepared to scale up and meet user expectations through clinical research and beyond. Moreover, ACROBiosystems can offer bespoke development services from scratch and guarantee that its products are structurally sound and approved for the production of cellular therapies.
Various expression systems, purification methods, and protein tags/labels can be chosen to improve the therapy’s efficacy.
Image Credit: ACROBiosystems
The custom GMP-grade protein services offered by ACROBiosystems are intended to deliver top-notch raw materials without impeding customers’ product development processes and provide comprehensive assistance for clinical trials.
About ACROBiosystems
ACROBiosystems is a leading manufacturer of recombinant proteins and other critical reagents to support the development of target therapeutics. The company employs an application-oriented development strategy, with a particular focus on product design, quality control, and solution-based support. Our products and services enable anyone in the field of drug development to have a more intuitive and streamlined process.
To respond to the coronavirus pandemic, ACROBiosystems has developed SARS-CoV-2 antigens specifically designed and optimized for serological test kits, including Spike-derived antigen S1, RBD, and Nucleocapsid protein. Proteins have been supplied to diagnostic companies in large quantities.
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