Cell therapies and other novel biologics have been touted as the next breakthrough pharmaceutical drug that is posed to revolutionize cancer therapy. Stemming from the successful commercialization of several cell therapies, other innovative biopharmaceuticals are flowing through the drug development pipeline. To support this influx in demand, the production of relevant cell therapy raw materials must also be scaled-up. Furthermore, regular guidelines managing the performance, quality, consistency, and safety of biologics’ raw materials have increasingly become a focal point within this industry.
To address and meet the needs of cell therapy manufacturers, ACROBiosystems has launched its custom GMP-grade protein services. ACROBiosystems, a cornerstone of the global biopharmaceutical and health industries, has accumulated over 10 years of experience in protein development and manufacturing, with over 5,000 recombinant protein products.
For their GMP-grade products, ACROBiosystems emphasizes their strict compliance to the regulations regarding cell therapy raw materials and its excipients. Their advanced protein expression technology, comprehensive quality management system and quality controls, and third-party audited GMP facilities, help ensure batch-to-batch consistency. Strict process controls and testing are performed to eliminate potential contaminants including viruses, mycoplasma, endotoxins, and others; all of which follow relevant regulatory requirements. Each step is performed automatically or under sterile conditions to minimize any contamination risk while using an animal-component free process.
ACROBiosystems’ custom GMP-grade protein service offers two different development methods to facilitate the transition from the preclinical to clinical phases. One method is to select a non-GMP proteins from their extensive catalog to be manufactured as a GMP-grade products. Since their GMP-grade protein products utilize the same manufacturing methods as their non-GMP counterparts and maintain the same level of performance, customers can initially use non-GMP proteins to save time, costs, and meet their deadlines. Otherwise, ACROBiosystems can also provide customized development services to develop products from scratch that are structurally designed and validated for cell therapy use as raw materials, offering various expression systems, purification methods, and protein tags/labels.
ACROBiosystem’s 10-year expertise in developing high-quality recombinant proteins enables their customers to obtain the optimal GMP-grade protein raw material for their cell therapy needs; all without disrupting customers’ development process and providing comprehensive support to begin their clinical trial research.