---
title: 'Manufacturing Daily Summary: What Happened on October 23, 2026'
headline: CMC requirements remain a late-stage risk in rare-disease drug development
description: A separate podcast discussion covered Merck’s manufacturing capacity,
  supply network and use of digital tools.
url: https://thebench.bio/news/manufacturing/2026-10-23
topic: manufacturing
date: '2026-10-23'
covers:
- '2026-10-23'
date_published: '2026-10-24T00:03:13Z'
date_modified: '2026-10-24T00:03:13Z'
tags:
- Manufacturing
- Regulatory
sources: 2
publisher: TheBench.Bio
---

# Manufacturing Daily Summary: What Happened on October 23, 2026

**CMC requirements remain a late-stage risk in rare-disease drug development**

A separate podcast discussion covered Merck’s manufacturing capacity, supply network and use of digital tools.

## Today in brief

Elisabeth Gardiner and Donny Xu called chemistry, manufacturing and controls (CMC) the biggest late-stage risk for rare-disease drug developers. [1] Xu said unmet CMC requirements led several companies to receive FDA complete response letters, not deficiencies in safety or efficacy data. [1]

## CMC requirements can derail rare-disease applications

Gardiner and Xu identified CMC as the biggest late-stage risk for developers of rare-disease treatments. [1] Xu said several companies had received FDA complete response letters because they had not met CMC requirements, rather than because of inadequate safety or efficacy data. [1]

## Also worth knowing

- On the Pharmaceutical Executive Podcast, Merck’s Dave Maraldo discussed U.S. capacity investments, manufacturing partners, digital tools and efforts to strengthen agility and resilience in the supply network. [2]

## Sources

1. [Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 2: CMC and Regulations](<https://www.biopharminternational.com/view/rare-pediatric-prvs-manufacturing-strategies-for-expedited-approval-part-2-cmc-and-regulations>), BioPharm International, 2026-10-23
2. [Building Biopharma Manufacturing for Speed, Scale, and Flexibility](<https://www.pharmexec.com/view/building-biopharma-manufacturing-for-speed-scale-and-flexibility>), Pharmaceutical Executive, 2026-10-23

---

TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing.

[1]: <https://www.biopharminternational.com/view/rare-pediatric-prvs-manufacturing-strategies-for-expedited-approval-part-2-cmc-and-regulations>
[2]: <https://www.pharmexec.com/view/building-biopharma-manufacturing-for-speed-scale-and-flexibility>