Defining Quality in Ancillary Materials
High-quality ancillary materials are critical to ensuring the regulatory compliance, clinical performance, and commercial success of advanced therapies. However, understanding how best to define, measure and analyze quality is particularly difficult. These materials are critical to the production of advanced therapies, but have only recently come under consideration by regulators and standard-setting bodies.
Ancillary materials can be produced and qualified at various quality grades
- Laboratory-grade: products or materials that are intended to be used within the laboratory or for research use and not intended for food, drug or medicinal/clinical use.
- Research use only: products or materials limited for use in research or pre-clinical applications only and not for use in clinical trials unless qualified appropriately and approved for use in a given application by applicable regulatory authorities. RUO products may be manufactured under various quality management systems, including ISO-certified or GMP.
- Good Manufacturing Practice (GMP or cGMP): regulations requiring manufacturers, processors and packagers to take the necessary steps to ensure that their products are traceable, safe, pure and effective. GMP denotes proper design, monitoring and control of the manufacturing processes, facilities and the final product and can be considered under a phased approach, depending on the phase and intended use of a product within a clinical application.
- Clinical-grade: products or materials that are suitable for clinical use, for example, injectable grade. Material shown to be safe and efficacious for human use through appropriate clinical trials and regulatory approvals. Clinical-grade products are typically approved as drugs by regulators and labeling or product documentation should state sterility and safety profile.