Top three considerations to set your HPAPI programme up for success

17th Nov 2022

In this blog, Senior Technical Manager at Sterling, Matt Miklas, discusses the key considerations in setting your high potency API (HPAPI) programme up for success. 

About the author: Matt Miklas joined Sterling in October 2013 as a Process Engineer and has since became Senior Technical Manager at our Germantown, Wisconsin site. He has a bachelor’s degree in Chemical Engineering from the University of Wisconsin-Maddison, and his specialisations include process engineering, process integration, GMP, and design of experiments.

Given their ability to offer more targeted treatments across a broad range of treatment areas, high potency APIs, or HPAPIs, continue to grow in popularity. In addition, more robust toxicological assessments and demand for greater safety precautions have resulted in more molecules being classified as highly potent, which has also contributed to their growth. In fact, the global high potency API market is anticipated to grow at a CAGR of 8.7 percent through 2026, reaching a total value of $32.2 billion.

With highly potent molecules in development on the rise, the demand for an outsourced HPAPI solution provider has also increased. Given the stringent containment controls necessary to safely handle highly potent intermediates and the high cost of related infrastructure, many pharmaceutical and biotechnology organisations turn to outsourcing. But selecting the right partner for your organisation can create an additional layer of complexity, as it is critical that an HPAPI partner fulfils several key criteria.

The decision to outsource HPAPI services is an important one, and selecting an appropriate partner is essential. Read on to discover the importance of a tailored HPAPI approach that is marked by a customised containment strategy, asset flexibility, and specialised teams and facilities capable of handling the full range of HPAPI requirements.

Customised containment strategy

When working with high potency APIs, all projects have different requirements. As a result, it is critical to work with a partner who possesses extensive toxicological expertise in order to shape a containment strategy that is tailored to a customer’s specific project requirements.

When designing a containment approach, comprehensive toxicological assessments are important to correctly classify materials and ensure that the necessary safety and containment measures are in place. Organisations generally leverage an occupational exposure band approach to define occupational exposure limit (OEL) levels and determine the appropriate control measures, with materials that fall into occupational exposure bands (OEBs) 4 and 5 requiring the highest levels of containment.

There are a number of other factors that should weigh equally into containment decisions, including the concentration of active ingredient required, the material’s physical properties, the unit operations involved in the process, and the potential level of employee exposure to the material. By carefully considering all of these factors, organisations can then shape an ideal, multi-layered containment strategy that is best suited for the specific requirements of a given high potency API programme.

Asset flexibility

In addition to a customised containment approach, organisations require the flexible assets necessary to support different levels of containment and other project requirements. The right partner will have the experience and discretion to understand where and when additional containment is necessary, without creating avoidable added costs and project delays. Furthermore, the equipment should provide the ability to pair HPAPI development and manufacturing with a variety of complex process considerations, like distillation, cryogenics, chromatography, hydrogenation and particle size manipulation, to name just a few.

Because high potency intermediates are often used in conjunction with other chemistries and technologies, organisations should have the capacity to customise their equipment configuration to support a broader range of process requirements without sacrificing safety.

Specialised teams and facilities

Due to the complex and sensitive nature of HPAPIs, facilities must be purpose-built to handle highly potent intermediates. These facilities should be designed with multiple layers of engineered containment controls in order to systemically mitigate risk. However, it is also important to note that the best facilities and equipment are only as effective as the teams using them.

Specialised teams with a demonstrated track record in HPAPI development and manufacture are integral to the success of a project. In addition, from a safety perspective, team members working with HPAPIs require specialised training and PPE to protect themselves from any hazardous materials. A team with deep HPAPI expertise can also support toxin and toxin-linker synthesis involving highly potent compounds for bioconjugation projects.

Finally, the right partner’s expertise should extend beyond HPAPIs, with the dedicated teams and equipment necessary to support the full project lifecycle, handling molecules from early phase through commercialisation. This will ensure complete continuity with a single, dedicated partner, mitigating the added costs, delays, and information gaps associated with frequent knowledge transfers.

Selecting the right partner for high potency APIs

Given the significant growth and widespread applications of HPAPIs, the importance of an experienced partner has never been greater. Many factors should be considered when selecting an outsourced partner, but a tailored containment approach, asset flexibility, and dedicated teams and facilities are among the most important.

At Sterling, we understand the challenges that arise when searching for the right small molecule HPAPI partner. That’s why we are committed to meeting our customers’ specific requirements for HPAPI projects. Our dedicated team undergoes comprehensive training to ensure that they are able to meet specified containment targets when handling highly potent compounds, and our GMP HPAPI manufacturing suites are purpose-built with multiple levels of containment. In addition, we provide support for bioconjugation projects at Sterling’s Deeside site through toxin and toxin-linker synthesis. With expertise spanning the entire molecule lifecycle, we can support a diverse range of process requirements while handling HPAPIs from early development to commercialisation.

Speak with an expert to learn more about the importance of right-sized containment for HPAPIs and how to develop a strategic approach for your programme.

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High Potency APIs

Germantown, Wisconsin, US