What to Look for in a Trusted cGMP Manufacturing Partnership
Ashley H. Fong, PhD, Business Development Associate | August 31, 2017
Taking a new cell therapy from early clinical trials all the way to commercial manufacturing is a long and difficult process that few have completed to date.
There are innumerable challenges that can undermine the commercialization of a new cell therapy, such as the cost of goods for the therapy, quality control issues, sustainability of the therapy and its scalability. When these factors aren’t accounted for as part of a comprehensive development by design (DbD) framework, it can hamper the success of the therapy or even turn it into a non-starter.
Having the right manufacturing partner can smooth out the process of commercializing your cell therapy and increase the odds of success. There are examples of cell therapies that, at one time, were unable to reach completion because of non-compliance with key current good manufacturing practices (cGMPs), but were ultimately able to reach commercialization because the cell therapy’s developer found a reliable manufacturing partner--such as the example in this case study.
Before taking on a new partner for your cell therapy, though, it’s crucial to know what to look for in a trusted cGMP manufacturing partnership.
What to Look for in a Cell Therapy Manufacturing Partner
One of the first things to consider when researching a manufacturing partnership is whether or not your potential partner has the capability to meet cGMP requirements or the specific needs of the client. This includes making sure the partner has:
cGMP-compliant manufacturing capabilities and facilities
Infrastructure for transporting materials in a safe, cGMP-compliant fashion (such as global logistics and cryogenic storage for cell therapy products)
Phase-appropriate cGMP quality and operations systems
Manufacturing Development (Process and Analytics)
Capacity for manufacturing and development requirements
Expertise in your manufacturing process
Without these specific capabilities, it’s highly unlikely that a manufacturing partnership will prove fruitful. However, there’s more to a successful partnership than simply having the capability to do the work.
Other factors to look for in a trusted cGMP partnership include:
Risk Identification and Mitigation
A prospective manufacturing partner should have processes and tools to help them identify risks before they become obstacles that limit your cell therapy. Proactively assessing automation, process changes, optimizations, and pitfalls at the very start of the clinical development process reduces the risk of costly delays and setbacks later in the process.
Then, your manufacturing partner should create strategies for mitigating risks based on how important each risk factor is.
A History of Overcoming Manufacturing Challenges
No matter how well-optimized a process is for a given cell therapy, there’s always an element of risk—the infamous “Murphy’s Law,” which postulates that anything that can go wrong will go wrong at the worst possible time.
So, instead of looking for a manufacturer who assures you that nothing will ever go wrong, it’s important to find a partner that has experience in dealing with unexpected challenges and overcoming them.
Trust and transparency are critical for overcoming manufacturing challenges. A manufacturer who’s willing to show you what’s gone wrong in the past, and how they fixed those issues, helps demonstrate the level of transparency you need to establish complete collaboration.
A true cell therapy manufacturing partner is one that will be adaptable to your needs and the needs of the therapy you’re developing. There is no perfect, one-size-fits-all templated approach to developing cell therapy, so flexibility is a must.
Collaboration is an essential component of the partnership. Many cell therapy companies desire a collaborative relationship with a CMO so that their voices are heard and concerns are addressed during the development and technology transfer. Pre-existing platforms may seem like an ideal environment to streamline the process, however, fitting all cell therapies into a cookie cutter offering can consequently change the overall process and ultimately the resulting cell therapy product.
One thing to look for in a manufacturing partner is their ability to learn and adapt to the needs of your program when necessary. This helps create a partnership that creates maximum impact for each stage of development from phase I trials all the way to commercialization.
Any manufacturing partnership requires strong two-way communication between both parties. When one party falls silent, it can lead to disastrous misunderstandings and delays.
When vetting a partner, see if they’re willing to work with the project management and communication tools you’re most familiar with. It’s also important to agree on certain issues, such as the frequency and nature of communication, as well as who the main points of contact will be at each organization. It is also important to develop a relationship with the account manager because this channel of communication will ensure a positive client experience.
By sharing information quickly and consistently, therapy progress can be easily monitored and controlled. This makes it easier to resolve issues when they arise and prevent misunderstandings.
Your cell therapy is your intellectual baby—and protecting it is a major concern. When vetting a manufacturing partner, you need to be able to trust them with the safety and security of your intellectual property rights.
Ideally, your manufacturing partner should have a spotless record and a strong set of protections for their data to minimize the chances of your IP being lost or stolen. This includes having a strong focus on electronic record keeping, using strict cybersecurity, and creating a comprehensive disaster recovery framework in case the primary data center holding your information fails.
Contract and Development Manufacturing Organization—One Stop Shop
Developing a cell therapy product takes a village to help with the process improvements and manufacturing in addition to providing strategic advice for the development roadmap.
Many cell therapy companies have their own process development capabilities, however, they lack the expertise to develop a scaleable, closed-system process. A Contract and Development Manufacturing Organization (CDMO) that can provide consulting services would be able to provide a roadmap of process and analytical changes to ensure the survival of the cell therapy product throughout the clinical and commercial manufacturing lifecycle.
Additionally, it is important to have the capabilities to perform the process development into automated and closed systems. At that point, it would make sense for the same CDMO, who has now become an expert in your process, to seamlessly transition into the clinical and commercial manufacturing.
These are some of the most important qualities to look for in a trusted cGMP cell therapy manufacturing partner—qualities that PCT exemplifies.