Moving into Clinical Trials and need to find GMP Suppliers

[Imecoli]

Greetings all,
I'm back again with another obscure question, or at least to me. Our process, we will take tissue from a patient, manipulate it, then re-inject it into the individual (Ex Vivo). The problem is most of the cell culture materials we will be using are for IVD or RUO only. Other than qualifying the product (advice on how to do this, we will send out for sterility and endotoxin testing) does anyone know what else can be done to locate GMP materials or justify the other materials use? Some facilities will only make GMP materials under contract with minimal volume requirements and we are not yet looking at those volumes to have it expire on the shelf.

Any help would be greatly appreciated.

Matt

 

[thnksnow247]

This is a very complex topic with evolving requirements depending on where you are in the development and regulatory pathway. You should look to hire a regulatory consultant (or several) familiar with this type of therapy. This is about as complex as it gets. Your requirements at an early investigational stage are likely different than at full scale commercial use.

GMP may not be your big initial problem. Will suppliers even sell you their products for your intended purpose? Using them outside of IVD and RUO may be a breach of your purchase contract in the first place. Many products require significant additional contracting and liability management strategies for investigational use. You can also be considered negligent in the event that something goes wrong because you are using a product in a way that it was specifically labeled not to be used for. You will ultimately need to work with suppliers and make a commercial justification that outweighs the their liability exposure. That is how the minimums come into play. You may be able to setup contracts that provide you with small amounts of product while limiting their liability exposure (limits on number of patients treated, defined regulatory pathway, bonds, insurance wrappers).

Also, most suppliers are willing to sell you a small amount of product if you pay the same amount as a larger amount.