The COVID-19 pandemic has significantly disrupted supply chains and production schedules around the world. It underscores the importance of having a robust supply chain strategy and being ahead of challenges before they arise.
Understanding the complexities of supply chain management in Good Manufacturing Practices (GMP) production of your cell and gene therapy (CGT) products can help you make an informed decision when choosing your contract development and manufacturing organization (CDMO) and avoid supply chain disruptions.
Here are three things you should ensure that your CDMO considers so that your project will stay the course.
1. Data-Driven Planning to Get Ahead
An important aspect of proactive planning is to create a demand signal – this is a message to suppliers that goods are required. Your CDMO should use a data-driven process to forecast and predict product demands to routinely communicate to suppliers. These demand signals are used by suppliers to make important decisions about how much to produce and when.
Good supply chain leaders know that the larger a demand signal (e.g. the amount of supplies needed), the more you can drive production. Your CDMO should be using a demand planning approach to create the strongest demand signal by aggregating demand data.
2. Relationships Matter
Strong supplier-customer relationships are the foundation of a robust supply chain. Relative to traditional therapeutics (e.g. small molecules, enzymes, antibodies, etc.), CGT supply challenges are more complex and nuanced, and therefore the strength of these relationships is even more important. CGTs are emerging technologies that are primarily in the research and development and early clinical trial phases. Therefore, many suppliers in the CGT space produce mainly research-grade material, which means GMP supplies are produced in smaller scale runs that don’t happen as frequently. Your CDMO should have a solid network of suppliers they are constantly in contact with so that they can secure GMP material in a timely manner.
To mitigate these issues at a tactical level, be sure to ask if the supply chain team at your CDMO is coordinating weekly communications with key suppliers to review orders, especially for materials that are supply-constrained. A high level of engagement with suppliers is important for communicating demand signals early and increasing stability of supply.
Confirm if the supply chain team at your CDMO has a backup for each supplier. Their relationships should include multiple qualified suppliers for the same materials. In the instance that one supplier encounters a shortage, your supply chain team must be able to quickly activate a second source.
3. Making Recommendations Tailored to Each Customer
The supply chain team at your CDMO will work closely with you to analyze your supply needs and make recommendations to streamline manufacturing and reduce costs. They will provide advice on supplies that will be optimal for your process. In many cases, this means they will make recommendations to use supplies (e.g. reagents and consumables) that they have experience with.
As a result, the CDMO can create a stronger demand signal by putting in larger orders with suppliers and increasing certainty of supply, which benefit both you and the CDMO. Using the same supplies with different customers can help streamline the CDMO’s internal processes, making it faster to receive and release materials for use in the manufacturing facility.
By working closely with customers to understand their supply needs, a CDMO can anticipate and mitigate the risk of issues early on. For instance, the COVID-19 pandemic has temporarily increased demand and lowered production of many materials and consumables. Demand for certain key supplies has increased as COVID-19 vaccine researchers and manufacturers continue to ramp-up efforts and this is further exacerbated by end-users stockpiling supplies. At the same time, suppliers have been forced to reduce the number of people in their facilities to meet COVID-19 physical distancing requirements, and thus operating capacity has been affected.
No matter the challenge, the supply chain professionals at your CDMO must be able to identify materials critical to your process that are supply-constrained and develop a plan for securing those materials.
Ultimately, the most successful supply chain leaders are tenacious and will collaborate with you to complete critical follow-ups that ensure you have the right supplies when you need them.
Contact us (firstname.lastname@example.org) to learn more about how our supply chain expertise can help in the manufacturing of your CGT.