Evidence map›Paper›PMID 32839030›Full record

ReviewTrends in biotechnology2020

Process Analytical Technologies and Data Analytics for the Manufacture of Monoclonal Antibodies.

Murali K Maruthamuthu, Scott R Rudge, Arezoo M Ardekani, Michael R Ladisch, Mohit S Verma

Open access · bronzeAbstract readReview
In one paragraph

Review in Trends in biotechnology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.3field-weighted citation impact, top 4% of its field
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

22 citing papers in PubMed, 88 citations in OpenAlex.

  1. Article
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  3. Synthetic spectral libraries for Raman model calibration.Analytical and bioanalytical chemistry · 2025
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  18. CDMOs Play a Critical Role in the Biopharmaceutical Ecosystem.Frontiers in bioengineering and biotechnology · 2022
    Review
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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

5 authors at 2 institutions in 1 country.

Murali K MaruthamuthuBirck Nanotechnology Center, Purdue University, West Lafayette, IN 47907, USA; Department of Agricultural and Biological Engineering, Purdue University, West Lafayette, IN 47907, USA.
Scott R RudgeRMC Pharmaceutical Solutions, Inc., Longmont, CO 80501, USA.
Arezoo M ArdekaniSchool of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Michael R LadischDepartment of Agricultural and Biological Engineering, Purdue University, West Lafayette, IN 47907, USA; Weldon School of Biomedical Engineering, Purdue University, West Lafayette, IN 47907, USA; Laboratory of Renewable Resources Engineering, Purdue University, West Lafayette, IN 47907, USA. Electronic address: ladisch@purdue.edu.
Mohit S VermaBirck Nanotechnology Center, Purdue University, West Lafayette, IN 47907, USA; Department of Agricultural and Biological Engineering, Purdue University, West Lafayette, IN 47907, USA; Weldon School of Biomedical Engineering, Purdue University, West Lafayette, IN 47907, USA. Electronic address: msverma@purdue.edu.
Purdue University West Lafayette · USRMC Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Process analytical technology (PAT) for the manufacture of monoclonal antibodies (mAbs) is defined by an integrated set of advanced and automated methods that analyze the compositions and biophysical properties of cell culture fluids, cell-free product streams, and biotherapeutic molecules that are ultimately formulated into concentrated products. In-line or near-line probes and systems are remarkably well developed, although challenges remain in the determination of the absence of viral loads, detecting microbial or mycoplasma contamination, and applying data-driven deep learning to process monitoring and soft sensors. In this review, we address the current status of PAT for both batch and continuous processing steps and discuss its potential impact on facilitating the continuous manufacture of biotherapeutics.

Indexed as

Antibodies, MonoclonalBioreactorsCell Culture TechniquesTechnology, PharmaceuticalAnimalsCHO CellsComputational BiologyCricetinaeCricetulusDrug ContaminationHumansAntibodies, Monoclonalcontinuous manufacturingmonoclonal antibodiesprocess analytical technologysensorsspectrometryspectroscopy

Identifiers

PMID32839030
PMCPMC7442002
OpenAlexW3081027044

What OpenQuestion holds

Textmetadata
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.