White Paper

Strategies For Optimal Scale-Up And Technology Transfer Of Oral Small Molecules

Source: Catalent
Female scientist microscope-GettyImages-1453524892

The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition.

The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this white paper, experts demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs), and their impact on the finished dosage. Experts also explain how these approaches can facilitate the tech transfer of a program.

Learn more about identification of CMAs, CPPs, and CQAs of drug products and how to predict their impact on a formulation and manufacturing processes, as well as the primary processing technology in OSD manufacturing and how material characteristics dictate the unit operations method.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Drug Delivery Leader? Subscribe today.

Subscribe to Drug Delivery Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Drug Delivery Leader