Is your API ready for GMP scale up?

Developing a small molecule active pharmaceutical ingredient (API) is often a risky process so reaching the goal, be it first in human studies or commercial manufacture, requires data and material without incurring unnecessary delays or impact on costs. To do so, it’s important to start thinking about process steps and scalability early. 

During this webinar, you will learn: 

  • how to assess your process from safety to efficiency and robustness as well as understanding the solid form
  • the importance of having strong analytical methods to detect any impurities and their impact
  • what supporting analytical data is required prior to good manufacturing practice (GMP) manufacture which makes part of investigational new drug/investigational medicinal product dossier (IND/IMPD) filing

We will also discuss how Concept Life Sciences can support you in progressing your drug development journey from route design to process development, ensuring readiness for GMP manufacture. 

Submit your questions

Although this webinar was recorded live on 7 April 2022, you’ll still be able to submit questions to experts Caroline German and David Fengas through the webinar Q&A function and they will answer your questions live, following the presentation.

演讲嘉宾

  • David Fengas - Director of CMC services 
  • Caroline German - Technical Director (analytical)

更多信息

Who should attend? 

  • Anyone interested in material characterization to support process development
  • Anyone who is ready to take their API candidate into early development
  • Anyone who is interested in finding out the IND submission requirements
  • Anyone who is interested in finding out more about route design, process development and phase appropriate scale up

What will you learn? 

  • When to look at route design
  • SELECT criteria
  • Method development & validation key to process robustness – detecting your impurities
  • How to be GMP ready – importance of data in regulatory submission