Cell therapies are an integral part of the promising, fast-paced landscape of innovative therapies revolutionizing global health. In the race to develop the next best cell therapy product, manufacturers need to be acutely aware of the heavily regulated and stringent requirements for quality control in the manufacturing of these advanced therapy medical products. What does GMP-grade mean, and how are high-quality raw materials impacting the final product in this field?

Translation of any new discovery to a therapeutic application is an arduous and lengthy journey for all the stakeholders involved, be it researchers, patients, caregivers, biotech firms or regulators.

Not adhering to required standards – especially around quality and safety – in this translation process can be costly. It can lead to terminations of therapeutic development projects or shutdowns in production, with potentially high financial losses.

“When a product is used to directly treat humans, minor omissions could have grave consequences, such as failure to provide timely medical care to patients in need, or even cause patient harm,” highlighted Sheng Lu, Senior Director of Quality at ACROBiosystems, a biotechnology company that specializes in providing recombinant proteins, kits, antibodies, and other biopharmaceutical supporting services.

“Products for human use warrant more stringent quality and safety criteria, unlike for example, research-use-only products, which are used only in early stages of drug discovery and safety research.”

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This insight article is created by Labiotech.eu
Writer: Sudha Sundaram