Adapting to Demand: The Importance of Flexibility in HPAPI Small-Batch Manufacturing

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Webinar Date/Time: Thursday, October 12, 2023 at 11am EDT | 4pm BST | 5pm CEST

In this webinar, experts will address the challenges posed by manufacturing HPAPIs and suggest strategies to ensure the small-batch flexibility needed for HPAPI manufacturing.

Register Free:

Event Overview:

The use of High Potency Active Pharmaceutical Ingredients (HPAPIs) in drug production has seen a significant increase in recent times, especially in the creation of cancer therapies. These HPAPIs are present in up to 25% of the drugs available in the market. However, the process of producing such drugs safely and cost-effectively while meeting regulatory requirements is a significant challenge.
As the demand for low-volume drugs containing HPAPIs continues to grow, the need for flexibility in small-batch manufacturing becomes increasingly evident. Traditional manufacturing approaches may not be suitable for producing these specialized drugs in smaller quantities efficiently, hence, adopting flexible manufacturing strategies allows pharmaceutical companies to respond quickly to market demands while minimizing waste and costs.
In this webinar, experts will address the challenges posed by manufacturing HPAPIs and suggest strategies to ensure the small-batch flexibility needed for HPAPI manufacturing. Additionally, the panel will discuss various approaches to enhance the efficiency of small-batch manufacturing, such as risk-based operational frameworks, innovative technological solutions, and smart investments.

Key Learning Objectives

  • Gain insights into the market trends of HPAPI and small-batch manufacturing.
  • Discuss safety considerations, and operational strategies necessary for successful HPAPI manufacturing.
  • Learn how a CDMO can provide the expertise and adaptability required for cost-efficient HPAPI production.

Who Should Attend

  • Drug Developers
  • Consultants
  • Product Development
  • Project Managers
  • Program Managers
  • Procurement


Justin Mason-Home, BSc (Hons), FRSC
HPAPI Project Services Limited

Justin Mason-Home is a Fellow of the Royal Society of Chemistry, with over 20 years’ experience in supporting pharma companies and the management of potent drug safety. He is a pharma insider, is published and is a frequent chair/presenter at international HPAPI conferences. Justin formed HPAPI Project Services Limited in 2017, offering a high-level, practically focused and pragmatic resource to support (bio)pharma companies in the design, development and delivery of potent and HPAPI projects; from R&D, scale-up and formulation development, right through to full scale manufacturing. Justin has been involved in and has worked on potent and highly potent API projects for more than 22 years and specializes in technical complex and strategic projects. He has unique experience managing sensitive highly potent and toxic biopharmaceutical compound matters.

Kyle Fugit, PhD
Director, Commercial Readiness and Special Projects

Kyle Fugit is the Director of Commercial Readiness and Special Projects at Catalent’s facility in Greenville, North Carolina, which specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. In his role, Kyle is responsible for evaluating new project opportunities and the transfer of products into commercial manufacture developed internally by Catalent’s pharmaceutical development team and from external manufacturing sites. His team also oversees the design and implementation of high potent handling strategies for the overall site. He holds a Bachelor of Science degree in chemical engineering from the University of Alabama and a doctorate degree in pharmaceutical sciences from the University of Kentucky.

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