A two-part interview with Martin Wing-King, Vice President and General Manager, Site Head at Quotient Sciences – Reading
Martin Wing-King, Vice President and General Manager, Site Head at Quotient Sciences—Reading, discusses the capabilities offered on-site at Reading and expertise that our team offers in formulation development for both simple and complex dosage forms.
In this second part of our two-part blog feature on our Reading, UK site, Martin discusses Quotient Sciences’ approach to formulation development, explains how our experts approach “simple” and “complex” drug programs and choosing the most appropriate dosage form, and tailored solutions to meet the needs of pediatrics and rare disease drug programs.
Miss the first part of our series? Read it here.
Can you discuss Quotient Sciences’ approach when it comes to “simple” versus “complex” formulation development?
Over the years, we’ve become known for our expertise in “complicated” formulation development. In that context, we commonly consider programs requiring modified release, hot melt extrusion, and other solubility enhancement techniques as more complex. The Reading facility has 12 GMP manufacturing suites. With the space, equipment, and expertise that we have in Reading, we can develop tablets, solutions, suspensions, and inhaled dosage forms as part of our formulation development capabilities—all depending on what the customer needs to meet the solubility, bioavailability, and other criteria needed for their drug.
At the same time, we know that complex formulations are not always necessary to get into the clinic if the customer’s goal is simply to accelerate to FIH trials. The extra equipment that we recently brought online at Reading gives us capacity and tools to investigate simple formulations faster.
For example, “drug in capsule” (DIC) and “powder in bottle” (PIB) approaches give our customers the opportunity to get their drug product into the clinic quickly for a Phase I trial. In these cases, we would use the Xcelodose® machine for directly filling API into capsules with a high level of accuracy and fill quantities between 0.1 and 100mg.
These simple formulations are a great choice compared to alternative choices of hand filling or developing powder blend formulations. These approaches reduce analytical method development and manufacturing time, simplify stability requirements, and reduce API usage in Phase I studies—this also translates to savings, as the API can be conserved and used for later trials, or smaller batches can be made potentially of the API in the first place.
How is this increased demand and scalability helping to meet pediatric and rare disease indication needs?
Rare and orphan diseases often have a much smaller patient population and can be overlooked due to their commercial viability, low volume requirements, or complex patient needs. We’re proud to say that these are areas are where we are well suited, with both expertise and equipment available to take on these smaller batches and novel use cases for our customers.
Additionally, API for rare disease indications can be expensive or complicated to produce. It may even be in short supply. Conserving API is something we keep in mind for our customers’ programs. We have seen numerous times where a simple “drug in capsule” approach for Phase I and even Phase II trials saves and cost in developing more complex formulations, especially for pediatrics and rare disease use cases.
Finally, are there any examples of programs where Reading has worked with other locations in Quotient Sciences’ network? Is there one that stands out for you?
There have been several due to the nature of how we work as a business. We’ve done drug product manufacturing often in Reading to supply a clinical pharmacology program, such as a drug-drug interaction (DDI) study. Probably the best case is also where we conduct a Translational Pharmaceutics® program at our Nottingham Phase I clinic with healthy volunteers, as well.
Another example that comes to mind is an oncology customer who partnered with us for formulation development and manufacturing of their drug product, a potential treatment for liver cancer. In this case, the API supply was limited and at a very high cost per kilogram. Not only that, but there were long lead times for new batches of the API and a multiyear Phase Ib/IIa trial was being conducted in multiple countries and had to be dosed in oncology patients. Recruitment rates were likely to vary from clinic to clinic.
We overcame the API challenges by using a “drug in capsule” approach to conserve API and worked closely with the customer to manufacture batches to resupply clinics throughout dosing periods for their trial.
Based on favorable clinical data, we are now formulating the drug product that can be used in Phase IIb and beyond. The redeveloped formulation will be manufactured throughout 2024 to support Phase IIb dosing and we are in discussion about how our Philadelphia site may be utilized to support a larger Phase II/III program, potentially leading to commercial batches as they get ready for regulatory approvals.