On Feb 10 Charles River Laboratories International sold its holding in the business to UK-based Quotient for $75m (€71m) in cash.
Charles River, which bought QS Pharma last April, said: “the CDMO business was not optimized within Charles River’s portfolio at its current scale.”
The takeover is the second Quotient Clinical has made in a month. Last week, it also bought Florida-based SeaView Research Ltd.
Mark Egerton, CEO of Quotient, told us the firm aims to “replicate” its Translational Pharmaceutics platform in the US to address increasing customer demand over there.
Quotient provides development services for oral, inhalation, dermal and intravenous formulations, 90% being small-molecule products.
The firm’s platform is built to house both formulation development, GMP manufacturing and clinical trials at one site, to shorten time to the market and permit formulary changes as patient data is collected.
“It sounds simple, but it's actually quite unique and difficult to replicate. This is because CDMO businesses typically don't have much insight into the clinical data and objectives of a trial. The CRO and CDMO industries are very siloed structures, where there's little or no integration,” Egerton explained.
Real-time manufacturing
Quotient focuses on early phase drug development services, by integrating formulation development, real-time manufacturing and clinical testing to a single UK location – Nottingham.
A second facility in Edinburgh employs around 50 people to process clinical data, which Quotient also bought off of Charles River back in 2009.
The firm claims this affords its clients the opportunity to modify dose and formulation compositions in response to emerging clinical data (safety, pharmacokinetic or pharmacodynamic).
Egerton explained there is a qualified person overseeing the whole process, rather than passing on paperwork from one site to another: “They're actually intimately involved as the product Is being manufactured. It's a real advantage, as no one else really offers that, which is why we have so many US customers.”
Therefore, Egerton told us the firm’s priority with QS Pharma is to replicate the platform in the US market too, rather than embark on a UK expansion.
“A UK expansion may still happen in the future, but we felt the US move was the priority, driven by the concentration of clients out there investing into Pharmaceutical R&D - it's really where the action is,” he added.
Biologicals
Egerton told us QS Pharma will work exclusively on small molecules formulations, despite SeaView’s Florida sites having capabilities for biologicals too.
Quotient also has multiple biosimilar products ongoing at its Nottingham site, however, this is just for patient dosing and not manufacturing.
“The biosimilar work in Nottingham we've done to date has all evolved around a conventional process - where the pharma company has taken the responsibility to manufacture that we're going to dose (so simply a clinical trial unit) for these,” he explained.
“Although our platform development plan for QS Pharma could be translated to biologicals, this requires a completely different skill set and manufacturing infrastructure.”