Ensuring Clinical Grade Product Quality from Manufacturing to Delivery
This blog post focuses on the quality aspects of clinical-grade, GMP-compliant products and the importance of a comprehensive Quality Management System framework.
The quality and consistency of starting cellular material is governed by regulatory agencies according to GMP guidelines, which we defined in part one of this series. This is critical to the success of allogeneic cell and gene therapies because the cells are the therapeutic product and this is largely impacted by the donors, which we covered in part two.
It is essential for a supplier to manage all of these regulations and requirements to ensure the integrity of the supply chain. AllCells operates under a Quality Management System (QMS) framework; a set of quality standards that take into account industry best practices and regulatory requirements in mind to produce consistent, high-quality and robust research and clinical grade products. The clinical grade products adhere to additional GMP requirements, which fall under the umbrella of a company’s QMS and encompasses critical aspects of product manufacture, processing, testing and delivery including:
- donor management
- maintenance of a robust supply chain such as sourcing/validating raw material providers
- comprehensive equipment, facilities validation
- staff training
- operational SOPs
- product testing – validated product release assays and sterility testing
- document management systems
- established Corrective and Preventive Action (CAPA) plan to investigate discrepancies to prevent their recurrence
- cold chain handling and logistics
Our GMP-compliant cells meet all current FDA and European Medicines Agency (EMA) guidelines for quality biological products. Donors are screened and tissues are collected in accordance with FDA Title 21 CFR 1271 subparts A-C and provisions of subpart D. Additionally, AllCells meets EU directives 2004/23/EC and 2006/17/EC for procurement organisations.
AllCells’ clinical grade bone marrow and leukopaks are fresh, GMP-compliant and collected and processed in the California LeukoLab – Donor Care and Management Facilities. Apheresis collections adhering to standardised operational protocols at the IRB approved facilities are performed using the Spectra Optia® Apheresis System, an advanced apheresis platform for efficient cell collections while ensuring the comfort and safety of the donors with stringent QA oversight.
Following collection, our clinical grade products undergo quality control testing to ensure they meet predefined release criteria. Total cell count and viability assays are performed using validated AO/PI protocols. Additionally, sterility testing specified by USP 71 is performed on clinical grade products by qualified, third-party laboratories using compendial testing. The implementation of strict quality oversight from the donors through product shipment combined with the assurances provided by adherence to GMP requirements make up AllCells’ robust QMS ensuring the high standards are met for our GMP-compliant collections.
To ensure the quality of our product is maintained during delivery from our lab to yours, we’ve partnered with AeroSafe Global to provide cold chain logistics to eliminate the risk of transient temperature excursions during shipment. The insulated and reusable AeroSafe shipping package will maintain a safe temperature range (up to 96 hours after packaging) in accordance with ISTA 7D standards in summer and winter profiles.
We hope this blog series has given you some useful insight into GMP requirements and QMS framework used to produce clinical-grade cellular products.