Good Manufacturing Practice (also referred to as cGMP or current Good Manufacturing Practice) is one of the key quality control systems within the life sciences industry, the aim of which is to ensure product quality and safety as well as manufacturing consistence. These guidelines are in place so that products consistently meet the requirements for their intended use, and to ensure therapies are safe and efficaceous when administered.
In order for a cell therapy product to meet the regulatory requirements which include cGMP compliance, controls at multiple levels of the manufacturing cascade must be in place. Understanding GMP and ensuring a process is “GMP-compliant” can be complex and involved, and must be tackled from the earliest stages of product development.
While GMP guidelines are established, they are very often product and process-specific, which has led to confusion among cell therapy product manufacturers – which is unfortunate, because ensuring a compliant process through proper, early planning eliminates bumps that otherwise appear during the more advanced stages of the drug development process.
As a company that often provides guidance and support to other cell therapy manufacturers with implementation of cGMP practices, here we highlight 5 of the key elements to keep in mind when planning – or executing – your cell therapy process.
- Sourcing of raw materials
Raw and ancillary materials are at the core of every successfully commercialized cell therapy product. Traceability, source, quality, cost and grade are all considerations that must be made at the earliest stages in order to properly scale and plan the manufacturing stages.
Patient safety is of paramount importance when developing cell therapy products. Ensuring safety through proper traceability of raw materials and consumables, as well as their qualification and validation is a good first step to ensuring success. Other considerations, including in-process testing, final release testing, product sterility and how its intended use might impact sterility are key to eliminating contamination.
- Clearly defined and validated manufacturing process
Doing it once is fine, but making sure the process is robust and transferable is what the industry is really after. Cell therapy products are often difficult to quantify, therefore efforts within the industry are aimed at consolidating specifications and standardizing as many elements of the manufacturing process as possible. As a company, having a clearly defined, tested, and validated process goes a long way towards ensuring reproducibility. This is easier said than done, and there is a wide misunderstanding within the industry as to what proper validation includes. For those reasons, having a manufacturing partner who is well-versed in cGMP processes and robust manufacturing practices is beneficial.
- Up-to-date batch records
Tied in with robust, validated processes, having batch records that reflect those manufacturing processes to every minute detail is key. Straightforward, user-tested, and actively followed batch records can be thought of as a work of art, and – again – a manufacturing partner with a robust quality assurance department will go a long way to helping you achieve that.
- Suitable, validated release specifications
Certificates of Analysis, which outlines product quality attributes, accompany the release of most products in the industry. Yet setting those attributes in harder than it sounds – often, guidelines are set by the regulatory agencies as to the acceptable criteria, but often such guidelines do not exist.
There are multiple industry-wide initiatives that are attempting to standardize various parts of the cell therapy process. Akron has participated, just last year, in a workshop at the National Institute of Standards and Technology, the aim of which was to consolidate and standardize potency assays for cell therapy products. This is just one example – though there are many other organizations attempting to tackle the various disjointed elements of the cell therapy process in order to facilitate in setting clearer guidelines to companies developing cell therapy products.
Even without a comprehensive set of rules in place, developing a product that meets tight criteria is a challenge. A strong manufacturing partner, again, is key.
Here at Akron, we assist and support companies in their manufacturing campaigns – both on the regulatory level as well as on the process level. Please contact us to learn more and tell us about your process.