Article

What You Need To Know To Avoid Costly Delays In Your API Scale-Up

Source: Thermo Fisher Scientific

By Peter Pöchlauer, Principal Scientist, Small Molecules API, Thermo Fisher Scientific

What You Need To Know To Avoid Costly Delays In Your API Scale-Up

If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. For these reasons, a company must be aware of any potential conditions that could occur at a small-scale that could create major issues during commercial scale-up.

Traditionally, the development of a small-scale synthesis for an active pharmaceutical ingredient (API) and its scale-up to meet the materials demand for clinical trial phases is a sequential activity that passes through multiple sets of hands. Even if the synthesis used at a small scale is the same one used at a large scale, the developer must be prepared to encounter and react to any changes to the API’s quality attributes, such as by-product profile and physical form. If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. For these reasons, a company must be aware of any potential conditions that could occur at a small-scale that could create major issues during commercial scale-up.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of BioProcess Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: