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|March 14, 2023
Finding the Right CDMO for Your Niche Drug Project
Author(s)LGM Pharma
Tailored manufacturing capabilities are critical in a CDMO. But, when you’re sprinting to market with a niche product, a partner who can also source your raw materials and de-risk your regulatory pathway is everything. With the right partner, every point along the development and manufacturing value chain journey becomes accelerated.
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
AI Formulation: Regulators Want Data
2
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
3
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
4
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
5