Draft:Sterling Pharma Solutions

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) for the pharmaceutical industry. The company was founded in 1969 and currently has facilities in the United States, Europe and the United Kingdom.

Sterling is the largest contract maker of active pharmaceutical ingredients (API) in the UK. The firm delivers small molecule services spanning pre-clinical development to full commercial manufacturing, as well as antibody drug conjugate (ADC) development and manufacturing.

History
1969: The Sterling Drug API Facility is established in Dudley, Northumberland on the site of a former colliery yard and allotments.

1975: The Dudley paracetamol plant is commissioned and completed. At the time, it is the largest paracetamol manufacturing plant in Europe.

1990s: The firm begins to branch out into new ventures, constructing a new biological water treatment facility and pilot plant.

2016: Sterling Pharma Solutions is officially formed via a management buyout (MBO) of the Shasun Pharma Solutions site in Dudley.

Operations
Sterling Pharma Solutions’ small molecule services cover the range of services needed to support a molecule throughout its journey to market.

Sterling specialises in hazardous and complex chemistry, from drug discovery and clinical trials following Current Good Manufacturing Practices (CGMP) to scaling up and commercial manufacturing. The APIs that Sterling produces go on to become the active ingredients found in medicines.

The technologies and services Sterling uses include: solid-state chemistry, high-potency APIs, controlled substance manufacture, biocatalysis and flow chemistry.

The company has facilities in the USA and UK and employs over 850 people. An additional facility has also been acquired in Deeside, Wales specialising in the development of antibody drug conjugates (ADC) mainly used in the treatment of cancer. This facility boasts a dedicated bioconjugation team providing ADC development and manufacture. The firm also operates an API manufacturing facility in Ireland. This facility boasts a dedicated bioconjugation team providing ADC development and manufacture. The firm also operates an API manufacturing facility in Ireland.

Due to the level of dangerous substances used and stored onsite, the firm’s facility in Dudley, Cramlington is a top-tier Control of Major Accidents Hazards (COMAH) site.

Sterling has an exemplary compliance record with various regulatory bodies around the world including:


 * US Food and Drug Administration (FDA)
 * Medicines & Healthcare Products Regulatory Agency (MHRA)
 * Pharmaceuticals and Medical Devices Agency (PMDA)
 * Therapeutic Goods Agency (TGA)
 * Health Products Regulatory Authority (HPRA)
 * Ministry of Food and Drug Safety (MFDS)

The company is also a member of the Pharmaceutical Supply Chain Initiative (PSCI), an organisation helping suppliers practice responsible and safe supply chain processes by considering human rights and environmental sustainability.

Acquisitions and expansions
Acquisitions have been a key component of Sterling’s growth strategy, alongside investment into its existing facilities. The company’s acquisitions have improved the capacity and capability of its facilities through investment in new technologies and infrastructure. Various expansions have also allowed for the development of new expertise through significant recruitment.

Sterling has invested more than £75m in its sites between FY21-FY23.

2018: Sterling Pharma Solutions invests six million pounds into its UK pilot plant. This investment increases the site’s productivity as well as increasing capacity by 33%.

2019: GHO Capital acquires a majority equity stake in Sterling Pharma Solutions. This investment allows for further growth throughout 2019 and future years.

2019: Sterling Pharma Solutions acquires CiVentiChem’s facility in North Carolina, USA. This facility provides chemistry solutions for pre-clinical and early phase clinical supply.

2020: Sterling Pharma Solutions acquires Alcami’s facility in Germantown, Wisconsin. This facility is a large API development and manufacturing site providing additional capacity as well as new technologies, including the ability to develop and manufacture highly potent drug substances that require specific containment and specialised expertise.

2020: Sterling Pharma Solutions launches a multimillion-pound Material Science Centre (MSC). This expansion provides a range of specialist solid-state chemistry and milling services.

2021: A £10 million investment into Sterling Pharma Solutions’ Northumberland facilities is announced.

2021: Sterling Pharma Solutions acquires ADC Biotechnology’s Welsh site. The firm recognises the facility’s potential for developing upcoming treatments in oncology as well as its synergy with other sites.

2021: Sterling Pharma Solutions invests in a centre of excellence at its site in Dudley, UK. This centre allows for further research into commercial applications of continuous flow chemistry.

2022: A one-million-pound project to expand Sterling Pharma Solutions’ Deeside sites and facilities is announced.

2022: A $2.1 million project to expand Sterling Pharma Solutions’ North Carolina facility in Cary is announced.

2023: Sterling Pharma Solutions acquires Norvartis’ Ringaskiddy campus in Ireland. This state-of-the-art site provides extra capacity for the firm’s European customers. It also offers synergistic technologies and an ongoing supply agreement with Novartis to manufacture several APIs for cardiovascular, immunology and oncology medicines.

2023: Partners Group acquires a significant minority interest in contract development and manufacturing organisation (CDMO). This investment allows Sterling to expand its production across the UK, Europe and the USA.

2023: Sterling announces its fifth acquisition: NewChem Technologies, a chemistry services business in Newcastle upon Tyne.

Awards and achievements
2018: Sterling Pharma Solutions’ CEO, Kevin Cook, is shortlisted for the Excellence in Pharma: CEO of the Year award at the CPhI Pharma Awards.

2019: Sterling Pharma Solutions is named in The European Business Awards’ Ones To Watch list.

2019: Sterling Pharma Solutions wins a Queen’s Award (now known as the King’s Award) for international trade for outstanding short-term growth in overseas sales. The company’s overseas sales received an 80% growth across three years.

2021: The Germantown Area Chamber of Commerce award Sterling Pharma Solutions with their Business of the Year title. Sterling works to improve the lives of Germantown residents by supporting worthy initiatives focusing on education, environment and health care.

2021: Sterling Pharma Solutions achieves the title of runner-up for the Best Contract Research (CRO) Provider at the 2021 World ADC Awards.

2021-2022: EcoVadis Cold certifications for sustainability are awarded to Sterling Pharma Solutions’ Cramlington site. This recognition places the Cramlington site in the top four per cent of all companies globally and within the top one per cent of all pharmaceutical companies.

2022: Sterling Pharma Solutions’ Knowledge Transfer Partnership with Northumbria University is awarded the top grade of 'Outstanding’ by Innovate UK assessors.

2023: Sterling Pharma Solutions is named as the North East shortlisted nominee for the Medical/Life Sciences and Healthcare Award at the Insider’s Made In The UK Awards 2023.