The Nuts and Bolts of Good Manufacturing Practices
This blog post delves into deciphering GMPs and how they ensure quality and consistency of primary cell products that can be used for the manufacture of cell therapies.
This week, we are excited to kick off part one of this GMP blog series, where we will begin to decipher Good Manufacturing Practices (GMP) and how they ensure quality and consistency of primary cell products that can be used for the manufacture of cell therapies.
With the FDA approvals of several cell therapy products and many more progressing through the clinical pipeline towards commercial development, sourcing high-quality cellular materials has become a critical determinant of a cell therapy’s success. Particularly with allogeneic cell therapies becoming more feasible, access to donor cells that meet regulatory, quality and quantity needs is paramount. The initial material is harvested from human donors and is the most critical component of any cell therapy, however, it is inherently variable. As such, securing a reliable supplier is critical and failure to do so can result in unwanted manufacturing variability, poor quality or performance in the final cell-therapy product, regulatory compliance issues that result in costly delays and potential cancellations of clinical trials, minimising the odds of successful commercialisation. Working with a supplier that adheres to GMP can save money and time by mitigating supply-chain disruptions.
But what does GMP really mean in the context of primary tissues isolated for cell therapies?
GMP is a system designed to mitigate risks in pharmaceutical and biologics production and ensure products are consistently produced and controlled according to quality standards. Regulatory agencies, such as the FDA, Health Canada, the EMA etc. are responsible for developing and enforcing GMP standards.
Typically, GMP compliance is incorporated into a supplier’s overall quality management system (QMS), which covers a set of business processes focused on achieving quality policy and quality objectives to meet customer requirements. GMP broadly covers all aspects of production from the starting materials, production site and manufacturing equipment to the staff training and personal hygiene. In particular, there must be detailed documentation for any procedure related to the manufacture of the finished product to ensure that all steps were executed according to protocol and done correctly. Understanding GMP/GTP regulations and having quality systems in place to ensure product fidelity are absolutely critical for a supplier of apheresis peripheral blood products.
Additionally, for human cellular and tissue-based products (HCT/Ps), suppliers are also regulated by Good Tissue Practices (GTP) guidelines for the protocols and facilities used for manufacturing. GTP includes parameters like donor screening and infectious disease testing, product recovery, processing, storage, labelling and distribution.
A major bottleneck for cell therapy developers today is meeting the demand for high quality starting material to fulfil requirements for development and scale-up procedures, especially as therapies move closer to commercialisation. It may be sufficient in early-stage development to use local, regional centres to obtain starting leukapheresis material but large-scale commercial production necessitates the availability of healthy donor cells at scale and on demand that also meet regulatory guidelines for therapeutic use.
To meet the needs of the cell therapy market, AllCells offers fresh, GMP-compliant, clinical-grade bone marrow and leukopaks. Because each cell therapy program is unique, customised ‘made to order’ clinical-grade formats are available along with several standard formats. AllCells’ 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. AllCells, considered a procurement organisation, also meets EU directives 2004/23/EC and 2006/17/EC.
Other blogs in this series include:
- The Importance of Donor Management for Clinical Product Development
- Ensuring Clinical Grade Product Quality from Manufacture to Delivery