Sourcing & Development

Many discovery research programs look to build new molecules based on a common scaffold. Often having enough of an advanced intermediate is the bottleneck to advancing your research. Outsourcing the supply of your advanced intermediate to a high quality, low cost supplier can save not only considerable expense, but valuable time in progressing your research program.

We have an extensive network of contract manufacturing organisations in China and India that may be able to fill your needs. We only work with companies that we have personally audited and can assist in bridging the culture and language gaps to ensure the best possible outcome.

Need a hundred grams of API or a few kilograms to get you through clinical? We can help match high quality CMO's to the chemistry your molecule demands.

 The formulation and presentation of your product can have a critical influence on stability, shelf life and the need for further studies. We are able to assist in CRO identification and scoping for formulation development, leachable and extractable studies, specification setting, and stability studies.

We can assist in preparing the appropriate sections of the drug master file (DMF) and Chemistry Manufacturing & Control (CMC) dossier for regulatory filing. 

Want to do this yourself? We have a number of stability chambers and analytical equipment that are available to lease.

Your clinical candidate will almost certainly need some process development prior to commercial manufacture.

Process development looks to remove exotic reagents, dangerous or difficult solvents, and extremes of temperature and pressure. Process development seeks to minimise chromatographic steps and ensure reproducible yield and quality. Importantly, process development aims to minimise the cost of manufacture.

We at MoJo have extensive experience in Process Development and costing of processes. We can help you asses quotes and ‘scope of works‘ bids from contract manufacturing organisations.

We believe process development should be started as soon as the decision to enter the clinic has been made. Starting early allows you to get a picture of your products stability before it becomes a critical issue. Process development invariable makes changes to the route of synthesis and it is always best to conduct your trials with material produced by manufacturing method you intend to take to market. Often, process development results in new IP which can aid in partnering and capital raising.