The past year saw the active pharmaceutical ingredients (APIs) market marked by the rising demand for highly potent APIs (HPAPIs), with contract development and manufacturing organizations (CDMOs), including Lonza and Piramal, expanding their capacity to provide more in the sector.
Sterling Pharma was not left behind, implementing its previously announced plans for expansion with a ₤6m ($7.6m) scale-up operation at its facility in the UK, as well as with the acquisition of CiVentiChem’s facility in Cary, North Carolina, US, which signified the company’s general growth.
In-PharmaTechnologist (IPT) spoke to Andrew Henderson (AH), Sterling's sales and marketing director, to find out more about the demands of the HPAPI market, how it is set to evolve in 2020, and how the company plans to address the upcoming challenges.
He told us that scientific advances continue to push the demand for HPAPIs higher, driving the need for more efficient, faster manufacturing processes, lower costs and improved quality.
Moreover, he stated that the company intends to tap into new technologies and continue its expansion to meet those needs, as well as being on the lookout for further acquisition opportunities.
IPT: What were the main market needs in APIs during 2019?
AH: In response to demand for the industry to tackle increasing costs and product quality, companies were focused on finding innovative ways to perform the chemical transformations required to manufacture APIs. In a bid to improve transformation efficiency, development speed and more complex synthesis in higher yields, companies were exploring complex and hazardous chemistries to reduce the number of synthesis steps required. As a result, strong process hazard evaluation and hazardous capabilities have become a requirement for API manufacture. This allows firms to understand the hazards associated with a process and implement measures to eliminate or minimize impact on personnel safety and the environment. There are a number of specialist companies, like Sterling, which have expertise in this area, adding invaluable insight into the essential considerations during process design.
IPT: What will be the main challenge in the field in 2020?
AH: One challenge we are facing in 2020 is the growing demand for HPAPIs due to advances in therapeutic areas, such as oncology. The HPAPI market is set to reach $26bn (€23.3bn) by 2023, which means greater demand for service providers who can cater for these complex molecules.
HPAPIs require considerable knowledge and specialist skills to ensure safe handling and manufacturing, meaning much of this demand is being outsourced to contract development and manufacturing companies (CDMOs), such as Sterling, with established expertise in this area. While these skills are often not available in-house, CDMOs often possess the specialist equipment and knowledge and understand procedures required to ensure safe and precise manufacture of highly potent products.
IPT: As a result of this, what new technologies are expected to be most adopted this year?
AH: In line with demand for HPAPIs, hazard evaluation, process design and hazardous chemistries are becoming increasingly important. As more complex and highly potent products continue to enter the drug development pipeline due to growing demand for targeted therapies, it’s likely that more sponsor companies will look to outsource HPAPIs to partners with the expertise and capabilities to swiftly and safely manufacture hazardous products.
CDMOs need to be able to offer these specialist solutions as standard, as the ability to use hazardous chemistries can allow for a more direct route to a molecule and can shorten turnaround times as a result. These capabilities are often key factors in the selection of a CDMO partner.
IPT: What are Sterling’s main goals for 2020?
AH: At Sterling we are looking to continue broadening our capabilities in 2020 to allow us to meet the evolving needs of our customers and the industry.
Sterling’s new milling and solid form facility (MASF) is set to open in early 2020 and will enhance our range of milling and micronization capabilities, from development to commercial scale. We will be able to branch into new technologies such as mechanical milling, spiral jet milling, micronizing and small lab-scale trial milling, as well as expanding Sterling’s general laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection and particle engineering and crystallization scale up.
In addition, we are looking to grow our service portfolio and expand our presence in new markets. 2019 saw Sterling acquire the CiVentiChem facility in Cary, North Carolina, to grow our current good manufacturing practice (cGMP) API manufacturing offering, support our expert medicinal chemistry services and grow our global chemistry services offering. In 2020, we continue to explore other potential acquisitions that will further strengthen our services.
Andrew Henderson is the sales and marketing director of Sterling. Prior to joining Sterling, Henderson was a development chemist at Onyx Scientific and held sales and marketing, project management and corporate development positions at Aesica Pharmaceuticals and Shasun Pharma Solutions.