The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
|Articles|June 19, 2023
The Keys to Achieve Success with Commercial AAV Manufacturing Scale-up
Author(s)Thermo Fisher Scientific
How to achieve robust and consistent high-quality productivity for successful commercial manufacturing is dependent on clearly defining your criteria for successful scale-up. This article explains how using a fully optimized cell culture medium, and identifying it early in the development process, should be part of the criteria as they can avoid time-consuming and costly redevelopment at scale-up.
Related to this article
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Trending on Pharmaceutical Technology
1
AAPS PharmSci 360 2026: IND-Enabling Studies vs Animal Data
2
From URS to Acceptance Evidence: Defining and Testing Interfaces in Pen Injector Assembly
3
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
4
AI Formulation: Regulators Want Data
5