Are you looking for a supply partner to help you scale cell and gene therapy (CGT) manufacturing? Do you need a partner that can help you keep up with pre-existing capacity increases? These challenges may lead to some hard choices.
CGT is an emerging field. Its products are neither simple nor inexpensive. Their precursors require a specialized supply chain with products for both the blood and bioprocessing industries. This means that your ideal supplier may be difficult to find.
What to Look For in a CGT Supplier
Patients depend on CGT to solve life-threatening medical issues. Supply bottlenecks, quality issues, and communication problems can impact more than your bottom line. The best suppliers won’t just deliver a product. Instead, they’ll actively collaborate with you, altering their existing materials to provide the best match for your processes.
When you’re looking for a CGT supplier, it’s important to find a partner that meets the following criteria:
- Able to scale alongside a growing industry
- Meets stringent quality and purity requirements
- Understands and complies with regulatory requirements
- Provides expertise in handling complex customer support requests
Best-in-Class CGT Suppliers Deliver Availability and Flexibility
Critical materials availability is one of the most important aspects of a strong CGT supply chain. These materials include things like cell culture media, viral vectors, and gene delivery devices. They must be of the highest quality and available when needed to ensure the success of CGT treatments. Ensuring proper transport and care is essential to the viability of these fragile components. If a bag thaws or gets compromised, then what?
Another important aspect of a strong CGT supply chain is the flexibility to adapt to changes in demand. This is because the demand for CGT products is expected to grow rapidly in the coming years. Suppliers must be able to quickly increase production to meet this demand.
Lastly, suppliers should be able to ensure a consistent and high-quality supply of materials that might ordinarily be considered generic. One example of this is PVC tubing, which is one of the key components of a strong and reliable cell and gene therapy supply chain. This versatile material is easy to use for transferring cells and fluids, while also making it ideal for use with cell and gene therapy production. Any shortage could force CGT producers to seek lower-quality alternatives, or halt production altogether. Therefore, the ideal CGT supplier can provide both high-quality precursors and more fundamental materials.
Ensuring Continuity of Production for CGT
Here is some advice for building a strong CGT supply chain:
- Choose suppliers that have a proven track record of reliability and flexibility; look at how they performed during the coronavirus crunch.
- Establish open lines of communication with your suppliers so that you can quickly respond to changes in demand; assess whether they return your emails or quotes in a timely manner
- Conduct regular audits of your suppliers to ensure that they are meeting your quality standards
- Build a contingency plan in case of a supply disruption; look at potential backup suppliers
By taking these steps, you can help to ensure that your CGT treatments are safe and effective. Learn more about how we can help you avoid costly pitfalls here.
