Drug Product Development: Challenges and Strategies for High-Potent and Low-Dosed Products

Life Sciences, Drug Discovery & Development, Drug Safety,
  • Tuesday, October 10, 2023

The landscape of drug development is constantly evolving, presenting pharmaceutical companies with unique challenges that demand innovative solutions. Among others, critical areas that require special attention are highly potent active pharmaceutical ingredients (HPAPI) and handling of micro-dosed APIs at the same time. The webinar explores the challenges, and the measures drug developers and manufacturers must adopt to effectively handle HPAPIs, as well as solid dosage form technologies that allow for handling low-dosed APIs.

HPAPI handling stands out as a paramount concern in the current research and development (R&D) pipeline, accounting for a significant 50 percent of the projects. These potent APIs often exhibit remarkable efficacy even at extremely low doses. Consequently, drug product development companies must adopt a comprehensive approach to address the complexities that arise from HPAPI handling. This holistic concept revolves around three pillars: production equipment, processes and people.

Implementing specific concepts for shared facilities and establishing highly flexible setups become crucial factors for the fast and efficient development of drug products. These tailored approaches allow for quicker adaptation to the unique requirements of each HPAPI, ensuring safety, and maintaining high productivity levels.


A particular challenge lies in handling low-dosed APIs as they demand meticulous attention to detail. Ensuring a uniform distribution of the API throughout the formulation is critical for achieving safe and effective drug therapy. To address this issue, technology and formulation platforms play a vital role. Additionally, a comprehensive analytical setup and sampling process are mandatory to monitor the API’s performance accurately.

In some instances, low-dosed APIs pose difficulties when processed using standard technology. In such cases, fast-track formulation of clinical material becomes necessary. Here, micro-dosing technologies come to the rescue, enabling drug developers to overcome these challenges. By encapsulating micro doses in hard capsules, the physicochemical properties of the API remain intact, leading to enhanced therapeutic efficacy. Moreover, this approach facilitates special applications like inhalation, expanding the possibilities for drug delivery.

One significant advantage of micro-dosing is the rapid development of clinical study material. Defining effective dosage levels and studying the drug’s performance becomes more feasible with micro-dosing, thus expediting the overall drug development process.

To summarize, development service providers in the pharmaceutical industry must adapt to the ever-changing landscape brought forth by innovative APIs. This necessitates a thorough understanding of safety and quality measures, especially when dealing with HPAPIs. Moreover, mastering novel and highly engineered formulation and dosing technology becomes a crucial asset in overcoming the challenges posed.

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In conclusion, drug developers must be proactive in their approach to adapt to the current challenges in the R&D pipeline. By effectively handling HPAPIs, devising targeted therapy solutions and employing advanced formulation technologies, they can pave the way for successful drug development in the future.

Join this webinar to get insights into the challenges and strategies in drug product development and manufacturing and the safe and flexible handling of HPAPIs.


Florent Bordet, Aenova Group

Florent Bordet, Chief Scientific Officer (CSO), Aenova Group

Mr. Florent Bordet is a pharmacist by training (Pharm D) and holds a master’s degree in industrial pharmacy. He has over 25 years of experience at various CDMO market leaders, where he held high-level positions in R&D, manufacturing, technical operations, site and business unit management and business transformation.

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Klaus Pollinger, Aenova Group

Klaus Pollinger, PhD, Head of Manufacturing Science & Technology, Aenova Group

Dr. Klaus Pollinger is a pharmacist by training and holds a PhD in pharmaceutical technology. He has more than 10 years of experience in the pharmaceutical industry with site and corporate roles in Pharmaceutical Development and Manufacturing Operations. In these functions, he has been broadly working on high potent products.

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Martina Breuer, Aenova Group

Martina Breuer, PhD, Head of Operations / QP, Aenova Group

Dr. Martina Breuer holds a PhD in pharmaceutical analytics and has been with Aenova for many years. After positions as Head of Quality Assurance and Qualified Person, she is the Head of Operations from 2021 at the Aenova site in Münster. She is a subject matter expert in cleaning validation and handling of high potent products.

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Who Should Attend?

This webinar will appeal to professionals in the following fields:

  • Pharmaceutical drug product development
  • Manufacturing science & technology teams
  • Manufacturing operations teams
  • Quality engineering and quality assurance teams
  • Environment, health and safety (EHS) teams
  • Drug development and manufacturing outsourcing teams

What You Will Learn

Attendees will gain insights into:

  • Current view on trends, challenges and strategies in drug product development and manufacturing
  • Highly potent active pharmaceutical ingredients (HPAPI) handling and ensuring utmost safety and keeping flexibility at the same time
  • How low-dosing technology can be advantageous for current drug product development and manufacturing challenges

Xtalks Partner

The Aenova Group

The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. As a one-stop store, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes from pharmaceuticals to dietary supplements for human and animal health: solid, semi-solid and liquid, sterile and non-sterile, high and low dose, OEB 1 to 5 (Occupational Exposure Band). Approximately 4.000 employees at 14 sites in Europe and the USA contribute to Aenova’s success. Further information can be found at www.aenova-group.com.

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