Therapeutic Products Quality
‘Fit for Intended Use’ Product
The TPP Quality team is responsible for the creation and implementation of quality systems in compliance with internal and external quality standards as well as government regulations, as applicable, for current Good Manufacturing Practice (GMP) in both CPF and BPF. The Facility and its Quality system is accredited for more than minimal manipulation by the Foundation for Accreditation of Cellular Therapy (FACT).
Through stringent Quality Control and Quality Assurance measures, TPP Quality ensures that the environment, processes and materials utilized in manufacturing meet the standards necessary to generate high quality investigational products for clinical use.
ON THIS PAGE
Quality Control | Quality Management Program | Quality Assurance | Quality Management System
Schedule With Us
To request the support of TPP Quality Control for GMP test method development, validation and/or execution, connect with our product management group.
For more information about our quality services and how we can support your GMP production, contact us at:
Quality Control
The Quality Control (QC) team is responsible for developing, performing and review of all analytical assays required for quality control of raw materials, in-process and finished products, as well as execution of the Environmental Monitoring program.
All analytical assays developed and/or performed by TPP QC for the release of clinical products are validated according to cGMP and ICH Harmonized Guidelines.
Analytical assays currently available in TPP QC for release of GMP products include:
- Cell-based products QC: Gram Stain, Endotoxin, Mycoplasma, Cell counting and Viability assessment, Flow cytometry (cell phenotyping, transgene expression, cellular cytokine production detection), Chromium release assay and other functional / potency assays
- Biologics QC: Endotoxin, pH, Osmolality, Bioburden assessment, HPLC, ELISA including host cell protein, RNA Quantitation, Isoelectric Focusing, Immunoglobulin Isotyping, SDS-PAGE, Western Blot, Restriction Gel and UV-Vis Spectrophotometry
Quality Management Program (QMP)
The QMP is a comprehensive system of continuous quality assessment, assurance, control, and improvement. The program is designed to prevent, rapidly detect, and correct deficiencies that may adversely affect the integrity, safety and potency of therapeutic products.
These processes, illustrated here, are designed to ensure the manufacture of consistently high-quality products, but our organizational culture of quality is also critical.
Quality Management System (QMS)
The QMS is the tactical process that enables us to assess a product’s fit-for-use characteristics, identify operational and compliance risks and carry out continual improvement. These processes, illustrated here, are designed to ensure the manufacture of consistently high-quality product, but our organizational culture of quality is also critical.
View/download the full QMS flowchart.
