Predicting raw material impact on cell culture parameters in commercial biotherapeutic manufacturing.

Phyllis C Pugh, Bijay R Khanal, Jenna L Lemons, Mario A Murillo, Jacika N Patel, Preeya K Boppana, Veera Padmanabhan

Abstract read

In one paragraph

Article in Biochemistry and biophysics reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Phyllis C PughManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Bijay R KhanalManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Jenna L LemonsManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Mario A MurilloManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Jacika N PatelManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Preeya K BoppanaManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Veera PadmanabhanManufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Complex, chemically-undefined media components are often used as nutrients in the production of biological products via mammalian cell culture. Variability in the compositions of these complex raw materials can significantly impact product yields. This paper investigates the influence of raw material quality on the cell culture process by developing data-based models to estimate final productivity in an industrial antibody production operation at AstraZeneca. Fourier Transform Infrared (FTIR) spectroscopy measurements of selected raw material components were obtained. These measurements were processed, derivatized, and used to create Partial Least Squares (PLS) regression chemometric models. The resulting models were then employed to predict the influence of such raw variability on the yields of biotherapeutic molecules.

Indexed as

ChemometricsFourier-transform infrared spectroscopy (FTIR)Multivariate analysisPartial least squaresProcess analytical technology (PAT)Silico modelingSpectroscopy

Identifiers

PMID40821908

DOI10.1016/j.bbrep.2025.102192

PMCPMC12354791

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LicenceCC BY-NC-ND

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Registered trials

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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.