OSD

Bringing your high potent drug to market: Managing risk from development to commercial manufacturing

High potency drug development presents unique challenges, from containment and operator safety to API efficiency, scale-up and tech-transfer. In this webinar, we share how we support pharmaceutical and biotech companies in navigating these challenges through an integrated, risk-based approach spanning development, manufacturing and commercial supply.

The presentation provides an overview of Recipharm's high potency capabilities, infrastructure and project management approach, highlighting the key considerations that can influence the success of a high potency programme. Drawing on practical experience across oral solid dose and sterile manufacturing, the webinar explores how early risk assessment, containment strategies, scalable process design and structured tech-transfer can help reduce risk and support reliable manufacturing outcomes.

Attendees will gain insights into how Recipharm works with partners to accelerate development, maximise valuable API, support successful scale-up and create a clear path to commercial manufacturing.

What you will learn

  • Key considerations for developing and manufacturing high potency therapies
  • Why toxicology data and early risk assessment are critical to programme success
  • Approaches to containment, cross-contamination control and operator safety
  • How scalable development strategies can support smoother scale-up and tech-transfer
  • Ways to improve API efficiency and minimise material loss during development and manufacturing
  • How structured project governance and integrated teams support predictable execution
  • How Recipharm's capabilities and experience can help support high potency programmes from clinical development through to commercial supply
     

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