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Manufacturing RNA-engineered cell therapies is not only complex – it’s incredibly expensive. Most cell therapy companies rely on contract manufacturers to complete the process that typically totals $150,000 in final costs. And those are per-patient costs. 

However, there is an alternate route that cell therapy companies can take: Moving the entire cell therapy manufacturing operation in-house. Not only is this solution cost effective, it also gives companies more control over the process. 

An industry leader that has developed RNA-engineered cell therapies for auto-immune, oncology, and respiratory diseases that are currently in clinical trials, Cartesian Therapeutics is one of the first companies to bring their process in-house. And they did so with the help of InstantGMP™ PRO software. 

In the following article, you’ll learn about the cell therapy manufacturing process, discover the benefits of moving the process in-house, and see how InstantGMP™ PRO software makes the decision possible. 

The Cell Therapy Process

The cell therapy process begins with a single patient. A cell therapy company such as Cartesian Therapeutics receives blood from an individual patient. After the blood sample is acquired, the genes that are required to prevent or mitigate a disease or medical condition are edited. Once this phase of the process is completed, the blood with the edited genes is injected into the patient. This entire outsourced process can last anywhere from days until weeks. Every time this process is performed, the cell therapy must pay approximately $150,000 for the manufacturing costs. 

Moving Cell Therapy GMP In-House

Instead of continuing to outsource their processing to a contract manufacturer, companies can benefit greatly by moving their cell therapy manufacturing in-house. While this may seem like a near-impossible task, it’s actually quite manageable for cell therapy companies. They just need an appropriate facility and the right software solution. 

As the required batches are much smaller than traditional pharmaceutical or dietary supplement products, cell therapy manufacturing can be processed in a smaller facility such as a laboratory setting. And much like pharmaceutical and dietary supplement manufacturing, all blood processing must follow GMP compliance requirements. 

Knowing that their entire manufacturing process has to follow the same GMP procedures as a 10 million tablet batch, a cell therapy company such as Cartesian Therapeutics, can make the decision to invest in their own manufacturing and quality system. 

Using InstantGMP™ PRO software, cell therapy companies can easily move their process in-house. In addition to adhering to GMP compliance, this all-in-one manufacturing and quality system allows companies to easily manage their process internally in a small laboratory setting. 

Moving cell therapy GMP in-house with InstantGMP™ PRO also provides cell therapy companies with two major benefits: Increased cost savings and greater control of the process.  

Cost Benefits of In-House Cell Therapy GMP

One of the biggest advantages of moving cell therapy GMP in-house software is the cost savings the organization can enjoy. After implementing InstantGMP™ PRO software and adopting internal processing, Cartesian Therapeutics was able to reduce their exorbitantly expensive per-batch-cost to an expense that is much more manageable. 

Now, instead of paying a contract manufacturer upwards of $150,000 per batch, they are simply paying internal labor costs to process their batches. At the same time, InstantGMP™ PRO’s manufacturing and quality system helps them maintain the equivalent quality of product. Plus, this software solution also ensures that each batch meets the FDA requirements for manufacturing products that are used in clinical trials. 

Greater Control with In-House Cell Therapy GMP

Being able to meet tight deadlines and patient availability is critical for cell therapy manufacturing and clinical trials. Having control over the process is really important to meet these necessary demands. Unfortunately, when a cell therapy company outsources their processing, they are at the mercy of the contract manufacturer’s schedule.  

When companies move their cell therapy GMP in-house, they gain greater control of the entire process. In any clinical trial, companies must identify and procure viable patients and candidates that meet the necessary profile. Since patient availability is fluid, time is of the essence. When appropriate patients are located, companies must promptly react. 

With in-house capabilities and InstantGMP™ PRO’s built-in batch records feature, the company can better manage the entire manufacturing process. A patient’s blood sample can be easily acquired. Then the genes can be spliced, reconstituted and administered into the patient’s bloodstream more efficiently and effectively. 

“From a manufacturing perspective, I think it’s absolutely critical to have your own facility in cell therapy,” said Murat Kalayoghu, M.D. of Cartesian Therapeutics in a recent interview with BIOPROCESS Online. “We started off on this path with a CRO (Contract Research Organization). It was very motivated and did a fine job, but we recognized that approach just wasn’t going to allow us to learn as much as possible for each and every engineering and production run.” 

This swift action allows the clinical trial to be completed in a faster time frame. This type of efficiency is a huge advantage as it results in a fixed cost and fixed time. The faster a company can complete a clinical trial, then the more efficient and effective they can be with their available funds. 

Conclusion

As you can see, there are many advantages when companies bring their cell therapy manufacturing and processing in house. Greater control, cost savings and more timely results are just a few of the benefits companies can enjoy. And InstantGMP™ PRO all-in-one manufacturing and quality system software can make the migration to in-house cell therapy GMP processing possible. 

To learn more about how the InstantGMP™ PRO can help your company bring its cell therapy processing in-house, contact us today!

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