Life Sciences

Sterling Pharma goes from ADC strength to strength in response to industry demand

By Will Chu

CPHI provided an opportunity for Sterling Pharma Solutions to update on business strategy off the back of recent facility investments.

At CPHI in Frankfurt, Sterling Pharma Solutions were on hand to provide a business update, particularly the efforts made by the UK-based CDMO to expand its analytical and development capabilities.

Sterling is coming off the back of a recent £1 million (€1.1m) expansion project at its dedicated bioconjugation and antibody-drug conjugates (ADCs) facility, expanding laboratory space and additional service capabilities in the process.

 

“It’s been growing demand for that business from a development perspective,” explained Mathew Minardi, Executive Vice President at Sterling.

“And it’s really gearing up for the MHRA inspection and getting certified to be able to execute CGMP programs in the ADC area.”

The facility in Deeside, UK is set to expand from its current laboratory space from 275 to 419 square metres, with plans to recruit up to five additional scientists.

Novartis site acquisition

Sterling has recently announced a £1.5m (€1.7m) expansion project in Cary, North Carolina; and a planned £10m (€11.4m) investment in process development and commercial-scale manufacturing capacity at its headquarters in Dudley, UK.

Additionally, in March 2022, Sterling announced a deal to acquire Novartis’ 110-acre Ringaskiddy API manufacturing campus as part of its plan to expand its global footprint.

“The series of investments have been planned over time,” Minardi explained. Just as those needs were generated, we were executing on a plan that we put together, quite some time ago to continually increase our capability. The plan has been focused mainly on the API industry.

“As our pipeline grows, we need that extra capacity and serving customers in the right areas,” added Sterling’s Marketing director Emma Greenwood.

“70% of our customers are in the US. We’ve got two US sites now and the Novartis Facility  acquisition, will place us firmly in Europe. That’s likely to go through by the end of this year.”

More than an API partner

Minardi and Greenwood go on to the discuss the evolution of the complex molecule and the insights gleamed from its chemistry that is growing its role in a number of therapeutic areas.

The feeling now is that an API manufacturer needs to expand its offering to offer more within a collaboration.

“It’s definitely about the right partner,” said Minardi. “I think within the industry, one of the things that we see is that the values of Sterling, how we do business, the partnership really resonates with the customers and they appreciate that transparency that we provide.

“We talk a lot about one Sterling and one approach that we need to have,” he said “There were 34 or 35 cross site projects that we’ve worked on in the last couple of years.

“So how we integrate amongst the sites and leverage the expertise and assets within the different sites, is really critical and adds value to the customer.

Sterling and MIB COVID pact

As the industry slowly gets back to normal post-pandemic, Sterling have built on its recent partnership with the University of Manchester Institute of Biotechnology (MIB), formed in December 2021.

The aim of the collaboration is to support the development of a novel, low-cost manufacturing route to Molnupiravir, a new anti-viral drug for the treatment of COVID-19.

The route now uses a novel enzyme, cytidine aminotransferase, which would reduce the manufacturing cost of the drug.

The process has now been transferred to Sterling’s UK facility in Dudley to scale up to multi-kilogrammes.

This could then allow generic pharmaceutical manufacturers to produce large-scale quantities of Molnupiravir for lower-income countries, subject to authorisation.