Evidence map›Paper›PMID 41743609›Full record

ArticleAAPS open2025

Recent trends in pharmaceutical freeze-drying and control strategies observed in human drug applications and manufacturing inspections.

Steve Y Rhieu, Maxwell Korang-Yeboah, David D Anderson, John Arigo, Thomas O'Connor, Rakhi Shah

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in AAPS open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Steve Y RhieuOffice of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Maxwell Korang-YeboahOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
David D AndersonOffice of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
John ArigoOffice of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Thomas O'ConnorOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Rakhi ShahOffice of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Freeze-drying has been a workhorse for the pharmaceutical industry to enable long-term storage and long-distance transport of drug products that are unstable in liquid or frozen form. The importance of freeze-drying was particularly evident in the development and storage of life-saving medicines such as mRNA-based vaccines during the COVID-19 pandemic. In response to growing demand for improved manufacturing efficiency, emerging freeze-drying technologies spurred by the U.S. Food and Drug Administration (FDA) Pharmaceutical Quality for the 21st Century Initiative have been introduced with the aim to modernize the pharmaceutical manufacturing sector. Here, we provide regulatory considerations for emerging technologies in pharmaceutical freeze-drying from a manufacturing perspective. We also present an analysis of current trends in freeze-drying and in-process controls submitted in human drug applications-24 New Drug Applications, 118 Abbreviated New Drug Applications, and 20 Biologics License Applications assessed between 2020 and 2023-seeking FDA approval. Additionally, we analyzed the Form FDA-483 Inspection Observations educed from 201 inspections conducted at manufacturing facilities performing freeze-dried parenteral operations between 2015 and 2019, to identify common compliance challenges and provide regulatory insights for the pharmaceutical industry.

Indexed as

Continuous manufacturingEmerging technologiesFreeze-dryingLyophilizationManufacturing controls

Identifiers

PMID41743609
PMCPMC12930400

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.