Cell & Gene Therapy Product Characterization
Cell and gene therapy products are a class of therapeutic drugs requiring special attention and understanding when it comes to the presence and characterization of visible and sub-visible particulate matter.
The presence and characterization of visible and sub-visible particulate matter in parenteral products is a critical consideration during development, manufacturing, clinical and commercial release, and investigations. Established analytical methodologies for testing and regulatory guidance is well understood for pharmaceutical parenteral products; however, specific methodologies for cell and gene therapy products are not as mature.
The detection of particulate matter defects, or “foreign particulate matter” in cell and gene therapy products is a critical aspect to both manufacturing and quality assurance. Gateway Analytical employs several analytical methodologies to characterize and determine the potential sources of such particulates. Detection and characterization of foreign particulates is vital to the pharmaceutical manufacturing process, and a cohesive program should address remediation, reduction and ultimately elimination of foreign particulate matter.
Specialty Areas of Expertise:
Visible Particulate Matter Defects (“Foreign Particulate Matter”)
- Development and application of secondary testing methods to support internal visual inspection programs
- Specialized isolation methods for cellular products of varying densities
- Optical imaging and particulate sizing
- Identification and characterization testing by multi-analytical methods
- Comparisons to reference materials from the pharmaceutical manufacturing environment
- Expert opinion and consultation of the analytical data and results from testing
- Consultation in the development of particulate matter remediation and reduction programs
- Consultation in the development of personalized particulate matter defect libraries
Sub-visible Particulate Matter Testing
- USP-complaint methods to support release testing by USP <788>
- Custom protocol creation, method development and method verification testing
- Expert services to differentiate cellular components from true particulate matter
- Specialized sample handling and preparation methods to ensure accurate results and minimize OOS investigations
- Identification and characterization testing by multi-analytical methods as necessary
- Controlled laboratory environments to minimize the occurrence of extraneous particulate matter contaminations