Our Previous Work
Here are just a few examples where the Maitland Team was able to step up to a challenge and provide critical input on a project. Not only do we get the job done right, but we were also able get it done on time and on budget.
We contracted to produce a venom-based oncology product for clinical studies in the EU. The task was to isolate the active protein from the venom mixture to a purity of 99.9% using chromatography and then aseptically package the product in 10 ml vials. We were able to demonstrate our capability at the purification and quality assessment of this investigational biologic drug according to the submitted clinical trial process. We were also requested to investigate scalable and robust method for production to meet future commercial demands. A process was identified, and the study continues in order to optimize and prepare for an upgrade to the Investigational Medicinal Product Dossier (IMPD).
A client asked us to prepare active and placebo formulas. The formulations were prepared without difficulty and they met all the required specifications. However, the placebo formula was not designed to be a true placebo formula and it could have unblinded the study. The client was notified, we redesigned a placebo formula, prepared it and shipped in time. Our clinical trials expert was able to step in when no randomization process had been installed and the products were labelled to ensure no clinical site errors. The trial was completed on time, and without incident.
A client requested a formula to be developed and stored in IV bags in such a way that it was protected from oxygen. Our intensive investigation revealed that this approach was not feasible and as a result, the drug product would be unstable. In order to save the project concept and keep the process on track, we converted the project to a glass vial format and in the end, the reworked process met the required specification. The client is now preparing to add this revised format to its clinical trial program.
A university group requested a novel intrapulmonary product for a clinical study in infants. The production request included formulation and aseptic filling. Given the sensitivity of the target population and the known preferences of the FDA, we investigated the available stability profile of the product. We also contacted the API manufacturer for additional information and eventually an interim thermal stability test was organized. For this initial test it was determined that the drug product could be terminally sterilized thereby increasing the level of sterility assurance of the product concurrently reducing the costs of production. The project was successful and completed on schedule.
A client with a complex product was having great difficulty in finding a site that could cost effectively produce their CTM made with hazardous APIs. Their search went on for 4 years but was unsuccessful. The project was presented to us and a solution was developed that resulted in the company building out a space to handle the hazardous drugs and organizing the clients to produce the CTM using their own staff. The client’s staff completed GMP training in order to be allowed to operate within the facility and assistance with the development of their standard operating procedures (SOPs) for product was provided. Because of our efforts and flexibility, the client is now looking forward to submission of an IND.