Evidence map›Paper›PMID 40579685›Full record

ReviewPharmaceutical research2025

Critical Needs and Opportunities for Advanced Manufacturing of Lyophilized Injectables.

Alina Alexeenko, Maxwell Korang-Yeboah, Serguei Tchessalov

Abstract readReview
In one paragraph

Review in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

3 authors.

Alina AlexeenkoPurdue University, West Lafayette, IN, 47907, USA. alexeenk@purdue.edu.ORCID http://orcid.org/0000-0003-2123-9064
Maxwell Korang-YeboahOffice of Pharmaceutical Quality Research, CDER, FDA, Silver Spring, MD, 20993, USA.
Serguei TchessalovBiotherapeutics, Pharmaceutical Sciences, Pfizer Inc., Andover, MA, 01810, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lyophilized drugs and biologics have an outsized role in protecting public health due to their ability to provide extended shelf life for stockpiling. Over 70% (14 out of 19) of antibiotics on the Essential Medicines list are supplied as lyophilized sterile powders for injection (FDA, 1). Additionally, many new drugs, including first-in-kind medicines, such as the first checkpoint inhibitor cancer immunotherapy Keytruda, were initially introduced to market in a lyophilized form, accelerating availability to patients by several years while a stable liquid formulation was being developed. The article describes methodologies, both short-term and long-term, to address the current manufacturing challenges for lyophilized injectables based on the findings of the workshop by National Institute of Pharmaceutical Technology and Education held in January 2024.

Indexed as

Biological ProductsChemistry, PharmaceuticalDrug CompoundingDrug StabilityFreeze DryingHumansInjectionsTechnology, PharmaceuticalBiological ProductsAdvanced manufacturing technologyFreeze-dryingLyophilization

Identifiers

PMID40579685
PMCPMC12222488

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.