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.
News|Articles|May 28, 2026
Why Lyophilization Projects Fail, and How to Get It Right
Author(s)Jubilant HollisterStier
Scaling up a lyophilization process is one of the most technically demanding challenges in biomanufacturing, and even the smallest mistakes can lead to failed batches, delays, and extra costs. This white paper from Jubilant HollisterStier (JHS) shows how choosing the right partner can reduce risk, guarantee quality, and accelerate timelines and features a real-world case study of how JHS lead a successful Phase 3 oncology drug 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
AI Formulation: Regulators Want Data
2
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
3
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
4
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
5