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Unlocking the
potential of HPAPIs

With the rise of highly targeted therapeutics and complex new chemical entities (NCEs), the global demand for highly potent APIs (HPAPIs) continues to climb. HPAPIs are widely sought after for their ability to offer more targeted treatments at lower doses and with fewer side effects.1 As the number of highly potent molecules in development rises, so does the demand for an outsourced HPAPI solution provider.


Read on to explore the growth of highly potent molecules and explore key considerations to unlock their full potential in your organisation.

25%
of drugs are considered highly potent today.2

high potency drugs

Why the growth?


Several key factors have contributed to the growth of outsourced HPAPI development and manufacture.

Targeted therapeutics on the rise.

60% of oncology drugs today involve highly potent intermediates.3

Because of their ability to provide highly targeted treatments at lower doses, HPAPIs are commonly found in therapeutics for cancer, diabetes, asthma, autoimmune disorders, and more.4,5 Small molecule drugs currently represent the majority of sales in the HPAPI market.6

 

Enhanced toxicological assessments and improved health and safety standards.

APIs with an 8-hour average OEL of <10 µg/m3 generally call for contained processing.4

Advancements in toxicology assessments have made it easier to identify highly potent APIs. Recent drug design developments include leveraging high-throughput screening, toxicogenomics, and computational biology.4

 

High cost of entry and specialised equipment.

50% of biopharmaceutical professionals expressed plans to outsource HPAPI services.7

Because of the need for specialised facilities, equipment, personnel, and processes, it is expensive and time consuming for biotechnology and pharmaceutical organisations to handle HPAPIs in-house. As a result, many have turned to outsourcing.

 

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Choosing a
potential partner

Key factors for success when making your HPAPI outsourcing decision


Research estimates that there are roughly 96 CDMOs representing 130 facilities that deliver HPAPI services.7 But not all vendors are created equal. The decision to outsource HPAPI services is an important one, and selecting the right partner is essential.

Click on the five characteristics below to shape your search for a partner that will help you put the potential of HPAPIs to work.

  • Facilities

    Look for facilities that have been purpose-built to handle highly potent intermediates.

    Ask questions like:

    • Were your facilities designed specifically for HPAPIs, or have they been retrofitted from another use?
    • What kind of containment measures are in place?
    • What are the levels of protection in the event that a failure occurs?

    close

  • Flexibility

    Look for asset flexibility to support a variety of process demands, even within the same programme.

    Ask questions like:

    • Do you have the ability to support different forms and processes like cryogenics and milling?
    • Am I able to configure assets to meet my process demands without compromising containment?
    • How much room is there to expand assets as my needs scale?

    close

  • Personnel

    Look for specialised teams with a demonstrated track record in HPAPI development and manufacture.

    Ask questions like:

    • Do you have a designated team that is specialised in highly potent processes?
    • Have operators and support staff undergone training for HPAPI safety and containment measures?
    • Do you have strength in HPAPI-critical processes like powder handling, cleaning, and line breaks?

    close

  • Containment

    Look for right-sized containment strategies, shaped by a partner with deep toxicological expertise.

    Ask questions like:

    • Do you begin each programme with a toxicological assessment?
    • Do you continually reassess your containment approach, or adhere to your initial conclusion?
    • Do you tailor containment requirements based on the risk that exists, not just the hazard that is present?

    close

  • Comprehensiveness

    Look for a partner who can support your needs from development through to commercialisation.

    Ask questions like:

    • Which parts of the drug development lifecycle do you support?
    • What batch size are you capable of handling?
    • What is your compliance and safety record like?

    close

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Which characteristics matter most to you when searching for an HPAPI partner?

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Maximising the potential with Sterling

Delivering world-class HPAPI solutions


At Sterling, we understand the challenges you face when searching for the right small molecule HPAPI partner. Through our world-class HPAPI facilities, specialised processes, expert personnel, and uniquely collaborative approach, we address all of the characteristics that are key to maximising the potential of your HPAPI programmes.

Explore our cGMP manufacturing suites to learn more about our multi-layered approach to containment, and our dedicated HPAPI teams and processes. 

  • Specialised teamsOur dedicated HPAPI team, composed of some of the industry’s leading experts in handling highly potent compounds, undergoes comprehensive and specific training on control, containment, and cleaning.
  • Process designLeveraging our deep process engineering and optimisation expertise, we work with you to combine HPAPI-specific processes with best practices in small molecule API development and manufacture for optimal quality, safety, and efficiency.
  • Flexible assetsOur flexible asset configuration enables us to adjust our equipment and processes as needed to account for the specific requirements of your programme.
  • Multi-layered containment approachWe have a containment approach that safeguards processes and personnel through concentric layers of protection.
  • Process downflow boothsShould primary containment fail, they are fully enclosed in downflow booths with unidirectional airflow to direct any potentially hazardous materials away from operators’ breathing space and the wider facility.
  • Advanced engineering controlsPrimary controls within the equipment itself act as a first layer of protection, supporting containment of potentially hazardous particles at the nanogram level.
  • Isolated cGMP suitesIn the unlikely event that anything manages to pass through the first two safeguards, airlocks within the suites themselves prevent it from migrating to the wider facility.
  • Personal protective equipmentOur team members are equipped with PPE to protect them from potentially hazardous materials. Our isolation suites include designated areas for gowning and de-gowning, as well as misting showers for complete migration control.
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  1. Patnaik, T. HPAPI: When Less is More, 2011. Contract Pharma. https://www.contractpharma.com/issues/2011-09/view_features/hpapi-when-less-is-more/ (accessed Dec 14, 2020).
  2. Choosing the right CMO for outsourced work with APIs, 2015. Manufacturing Chemist. https://manufacturingchemist.com/news/article_page/Choosing_the_right_CMO_for_outsourced_work_with_HPAPIs/112307 (accessed Dec 14, 2020).
  3. Vatsa, K. Trends in CMO Market of High Potency Drugs, 2019. American Pharmaceutical Review. https://www.americanpharmaceuticalreview.com/Featured-Articles/363901-Trends-in-CMO-Market-of-High-Potency-Drugs/ (accessed Dec 14, 2020).
  4. Pavlovich, J. Classifying Potent and Highly Potent Molecules. Pharmaceutical Technology [Online] 2018, 2018 Supplement, s18-s20, s33. https://www.pharmtech.com/view/classifying-potent-and-highly-potent-molecules (accessed Dec 14, 2020).
  5. Haigney, S. HPAPI Capacity Challenges. Pharmaceutical Technology [Online] 2019, 2019 Supplement, s6-s10. https://www.pharmtech.com/view/hpapi-capacity-challenges (accessed Dec 14, 2020).
  6. Tiene, G. Targeted, Highly Potent Therapies: Big Growth Driver for the CDMO Market is Here…, 2016. Pharma’s Almanac. https://www.pharmasalmanac.com/articles/targeted-highly-potent-therapies-big-growth-driver-for-the-cdmo-market-le-here (accessed Dec 14, 2020).
  7. Munk, S. High Potency API Market Trends, 2016. Contract Pharma. https://www.contractpharma.com/issues/2016-09-01/view_features/high-potency-api-market-trends/ (accessed Dec 14, 2020).