Exhibit Hall Theater
Qualifying GMP or cGMP (current Good Manufacturing Practice) raw materials is a responsibility that falls upon cell therapy manufacturers. Finding a good supplier that can support the transition to clinical manufacturing is crucial in regulated manufacturing. As an expert in protein manufacturing, our stringent quality control and regulatory support enables us to offer industry leading GMP proteins for ancillary use. From our perspective, we see numerous considerations in selecting a GMP raw material supplier begins long before entering clinical trials. Early adoption of GMP raw materials can significantly streamline regulatory approval. By establishing robust quality control systems and documentation practices early on, researchers can avoid costly and time-consuming revalidation studies when formal GMP compliance becomes necessary. Additionally, utilizing premium, pre-GMP compliant materials can minimize the burden during transition. These materials often come with established quality control data, simplifying integration into GMP workflows. Our approach is to provide raw materials and solutions that help expedite the regulatory process and pave the way for smoother clinical trials for cell and gene therapies from discovery to the clinic.