Get help from seasoned development/CMC experts on any microbiome project.

Do you need a partner to help navigate this early but critical stage of your company’s progress toward producing an LBP that gets to the clinic? Here are some of the many things we can do while working with you.

Help with early stage understanding of the phases of microbial drug development and the pitfalls to avoid while developing the microbial asset.

Map the strategy for taking strains from isolation stage through to growth in fermentors, along with discussion/advice on the various preservation methods used with microbial products.

Define the experiments needed to confirm whether selected microorganisms are capable of being use as a therapeutic.

For clients who are already in Phase I or about to be in their first clinical trial with an LBP, we can offer help with:

Overall process development strategy, process optimization, technical reports and documentation, IND support, etc.

We offer help with all unit operations from medium choice and cell banking to fermentation and harvesting (including scale up) to lyophilization and other preservation method selection to blending and final dosage form selection.

Once you have been through the first clinical trial, you may need more help optimizing the process of production or altering the process to be used at a larger scale.

We can help examine the current data used to develop the Phase I process to suggest improvements/modifications to the process.

We can help define experiments to test steps in the process that are potential points of failure, reducing the likelihood of failed batches during manufacturing campaigns.

We can identify parts of the process that have the potential to improve overall yield and suggest ways to increase yield and/or potency.

In Phase III, minor changes to the process that make improvements in overall yield and potency can be explored.

Through a data-driven approach, we can examine all prior work and suggest experiments to explore process improvements, in addition to identifying areas that are targets of process efficiency.