Evidence map›Paper›PMID 39958269›Full record

ArticleChonnam medical journal2025

Biopharmaceutical Analysis by HPLC: Practices and Challenges.

Golshan Mahdi, Ashkan Alamdary, Hooman Kaghazian, Nayebali Ahmadi, Rajab Mardani, Alireza Gholami

Abstract read
In one paragraph

Article in Chonnam medical journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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.

Golshan MahdiPharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.
Ashkan AlamdaryDepartment of Research and Development, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran.
Hooman KaghazianDepartment of Research and Development, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran.
Nayebali AhmadiDepartment of Medical Lab Technology, Proteomics Research Center, Faculty of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Rajab MardaniDepartment of Viral Vaccine, Research and Production Complex, Pasteur Institute of Iran, Tehran, Iran.
Alireza GholamiDepartment of Research and Development, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

High-Performance Liquid Chromatography (HPLC) is an essential analytical technique in the biopharmaceutical industry, crucial for the separation, identification, and quantification of complex biological molecules such as monoclonal antibodies and recombinant proteins. It plays a vital role in assessing the purity, potency, and stability of biopharmaceutical products, which are critical for regulatory approval. HPLC offers high resolution and sensitivity, allowing for the detection of small quantities of compounds in complex samples. Its versatility is evident in various modes, including reversed-phase, ion-exchange, size-exclusion, and affinity chromatography. However, challenges remain, such as selecting the appropriate stationary phase, addressing peak overlapping and matrix interference, and optimizing operational parameters like flow rate and mobile phase composition. Standardization and method validation are essential for ensuring reproducibility, accuracy, and regulatory compliance in HPLC analyses. The need for reliable reference materials and calibration methods is also a significant challenge. Recent advancements in HPLC technology, including ultra-high-performance liquid chromatography (UHPLC) and hybrid systems that integrate HPLC with mass spectrometry, are helping to overcome these challenges by enhancing sensitivity, resolution, and analysis speed. In summary, as biopharmaceutical products grow more complex, HPLC's role will continue to evolve, highlighting the need for ongoing research and development to refine this critical analytical tool.

Indexed as

Biological ProductsChromatographic SystemsChromatography, High Pressure Liquid

Identifiers

PMID39958269
PMCPMC11821985

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.