Life Sciences

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

By Will Chu

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

At CPHI in Frankfurt, Sterling Pharma Solutions was on hand to provide a business update, particularly concerning 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 in Deeside, UK, expanding laboratory space and additional service capabilities in the process.

“Demand for that business from a development perspective has been growing significantly,” explained Mathew Minardi, Executive Vice President at Sterling.

“And now we’re really gearing up for the MHRA inspection and getting certified to be able to execute CGMP programmes in the ADC area.”

The facility is set to expand its current laboratory space from 275 to 419 square metres, with plans to recruit additional development and analytical chemists.

Novartis site acquisition

Sterling has also 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, Ireland, API manufacturing campus as part of its plan to expand its global footprint.

“This series of investments has been planned over time,” Minardi explained. Just as those needs were generated, we were executing on a plan to continually increase our capacity and capabilities, focused mainly on the API industry”.

“As our pipeline grows, we need that extra capacity in the right geographies for our customers,” 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 give us a world-class API manufacturing site in the European Union. That’s likely to go through by the end of this year.”

More than an API partner

Minardi and Greenwood went on to discuss the evolution of the complexity of small molecule APIs, and the insights gleamed from chemistry that is growing its role in a number of therapeutic areas.

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

“It’s definitely about being the right partner,” said Minardi. “I think within the industry, among the things that we see appreciated by customers are the values of Sterling and how we do business. This partnership approach really resonates with the customers and they appreciate the 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 has 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 reduces the potential 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.

Sterling’s growth continues to add both the technologies and capacity required by its customers, whilst retaining its focus on service excellence through the company’s values, which is integrated throughout its facilities.