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.
|Videos|February 2, 2022
Tech Talks: Cell & Gene Therapy Series
Author(s)PPD
Cell and gene therapies continue to expand rapidly, with an anticipated exponential growth over the next five years. This rapid growth has left an urgent need for industry scientists to gather and share lessons learned concerning bioanalytical, biomarker and regulatory strategies. This series provides insight from PPD Laboratories’ experts into a variety of cell and gene therapy (CGT) modalities in the bioanalytical community, with detailed discussions that leverage their experience with technologies and modalities within this CGT sphere.
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
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
2
AAPS PharmSci 360 2026: IND-Enabling Studies vs Animal Data
3
AI Formulation: Regulators Want Data
4
Formulation Risk Needs One Accountable Owner: AAPS PharmSci 360 2026
5