Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.
|Articles|November 18, 2022
5 CDMO attributes for successful late-phase tech transfers
Author(s)Thermo Fisher
Outsourcing projects to CDMOs is becoming increasingly prevalent as drug sponsors look to optimize their supply chain or conserve internal resources for other projects. In 2021 alone, 46% of newly developed drugs were outsourced. Drug sponsors can reap a variety of benefits by outsourcing late-phase projects, but it comes with risks. The technology transfer that must occur to transition a late-phase project to a CDMO is complex and costly. The average cost of a tech transfer is around $1M, so partnering with the wrong CDMO can be a costly mistake.
Related to this article
Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.
CDMOs announced expansions, exhibitors showcased automated equipment, and supply chain strategy discussions were a focus at CPHI Milan 2026.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
Trending on Pharmaceutical Technology
1
Using OEE Monitoring to Justify Expenditure on Aging Production Lines
2
Improving Oral Peptide Delivery Through Structural Modifications
3
Regulatory Roundup—October 2026: FDA Advances Rare Disease Development and Transparency Efforts
4
Drapeau’s AI Deep Dive: The Price of Acceptance in Regulated AI
5