High Potency APIs (HPAPIs)

Maximising the potential of highly potent APIs

With more drugs than ever classified as highly potent under development today, we are uniquely positioned to leverage our technical competency in high containment chemical synthesis with our extensive experience developing and scaling small molecules from their initial pre-clinical requirements through commercialisation into reliable ongoing supply.

Highly Potent APIs at Sterling

As the complexity of new chemical entities (NCEs) entering the small molecule development pipeline continues to surge, so too does the requirement to handle increasingly potent drug substances, or highly potent APIs. At Sterling, we utilise purpose-built facilities managed and operated by expert teams to phase-appropriately develop, scale and manufacture your HPAPI safely and compliantly. Core to our services as a leading highly potent API CDMO is a focus on primary engineering controls for protection. These facility capabilities are coupled with a culture of collaboration; we are committed to working closely with our customers in true scientific partnership to deliver their unique HPAPI project requirements. ... Read more

Following are some aspects of our approach that contribute to our strength in highly potent APIs:

  • Multi-layered containment: Our facilities were designed and constructed with multiple layers of engineered containment controls that systemically mitigate risk.
  • Support for the full-lifecycle: We are able to support HPAPI programmes beginning with pre-clinical quantities of grams, phase appropriate development scales, and into commercial manufacture with up to a 10 kilogram per batch scale at the highest level of containment.
  • Tailored solutions: We design processes that meet your unique HPAPI project requirements, including considerations such as cryogenics, hydrogenations, distillations and particle sizing.
  • Commitment to compliance: Our highly potent API manufacturing suites are inspected by the FDA and adhere to global cGMP regulatory requirements.Read less

Key Benefits

Targeted treatments:

HPAPIs are in-demand for their ability to deliver highly targeted treatments at lower doses, resulting in fewer side effects.

Versatility:

Drugs for a variety of indications, including cancer, asthma, diabetes, and autoimmune disorders, include highly potent intermediates.

 Flexibility:

HPAPI development and manufacturing can be paired with a variety of process considerations, such as distillation, hydrogenation, and particle sizing, to meet specific product requirements.

A flexible and tailored approach to highly potent API manufacturing

We work to maximise success throughout the entire duration of our customers’ HPAPI programmes, from early development through commercialisation. We aid our customers in designing a process that fits their specific requirements while ensuring repeatable quality, safety, and efficiency. Our flexible asset configuration enables us to adjust equipment configurations to handle both solids, liquids, pyrophoric and other hazardous materials in a wide range of processes such as distillation, cryogenics, hydrogenations, and particle sizing. ... Read more

The asset flexibility afforded by our HPAPI manufacturing suites enables us to not only meet a diverse range of process requirements, but also scale to meet demand throughout your project’s lifecycle.

In addition, we perform a comprehensive toxicological evaluation at the onset of each programme in order to develop a custom containment strategy that is both safe and pragmatic. As more clinical data becomes available, we adapt our approach as throughout your project to ensure a continued, optimal balance between safety and efficiency. Read less

Safely handling HPAPIs through a multi-layered containment strategy

Highly potent API manufacturing requires stringent safety standards as well as specialised facilities and equipment. Our Germantown, US site is equipped with two high containment cGMP manufacturing suites that are purpose-built for the safe handling of HPAPIs. These suites are FDA approved and capable of handling batches up to 10 kilograms while adhering to regulatory requirements around the world. ... Read more

Our HPAPI manufacturing suites are designed with multiple, concentric layers of containment to systemically mitigate risk, including:

  • Advanced engineering controls with the equipment itself acting as a primary layer of protection containing hazardous particles at the nanogram level.
  • Process downflow booths with unidirectional HEPA-filtered airflow serving as a secondary layer of protection, directing potentially hazardous materials away from operators’ breathing air space and the wider facility.
  • Isolated cGMP suites perform as a tertiary layer of protection, ensuring that in the unlikely event of hazardous particles breaching containment, airlocks within the suites themselves with pressure cascades will prevent migration to the wider facility. Read less

An HPAPI manufacturing company that prioritises safety

At Sterling, we are passionate about protecting our people, your product, and our planet. In addition to placing engineering controls within the facilities themselves we take a number of additional measures to heighten our safety standards when working with HPAPIs. ... Read more

Our HPAPI team members are specifically trained on control strategies, containment solutions and cleaning considerations to work safely with the highly potent compounds they handle. They are secondarily equipped with PPE to further protect them from any potential exposure; our suites are equipped with designated gowning and de-gowning areas as well as misting showers to deliver optimal levels of containment control. Meanwhile, team members working in the broader facility are educated on HPAPI specific safety measures that contribute to our site-wide culture of process safety and risk mitigation. Read less

As with any hazardous process at Sterling, safety is our top priority when working with high potency APIs. Our specialised teams and facilities are equipped to develop and manufacture these highly potent compounds for our customers in a way that is safe, saleable, flexible, phase-appropriate and comprehensive. Adam Kujath | Senior Director of Technical Operations

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Germantown, Wisconsin, US

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