Evidence map›Paper›PMID 31677011›Full record

ArticleThe AAPS journal2019

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle.

Roman Mathaes, Linda Narhi, Andrea Hawe, Anja Matter, Karoline Bechtold-Peters, Sophia Kenrick, Sambit Kar, Olga Laskina, John Carpenter, Richard Cavicchi and 4 more

Abstract read
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In one paragraph

Article in The AAPS journal, 2019. 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. Review
  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

14 authors.

Roman MathaesLonza Drug Product Services, 4057, Basel, Switzerland. roman.mathaes@lonza.com.
Linda NarhiAmgen, Inc, One Amgen Center Dr, Thousand Oaks, California, 91320, USA.
Andrea HaweCoriolis Pharma, Fraunhoferstr. 18b, 82512, Martinsried, Germany.
Anja MatterLonza Drug Product Services, 4057, Basel, Switzerland.
Karoline Bechtold-PetersNovartis, 4056, Basel, Switzerland.
Sophia KenrickWyatt Technology Corporation, 6330 Hollister Ave., Santa Barbara, California, 93117, USA.
Sambit KarMolecular and Analytical Development, Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, New Jersey, 08534, USA.
Olga LaskinaWest Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, Pennsylvania, 19341, USA.
John CarpenterUniversity of Colorado, Denver, Colorado, USA.
Richard CavicchiNational Institute of Standards and Technology, Gaithersburg, Maryland, 20899, USA.
Ellen KoepfCommercial Product Support, Innovation and Investments, Pharmaceutical Development & Supplies, PTD Biologics Europe. F. Hoffmann-La Roche Ltd, Basel, Switzerland.
E Neil LewisMettler-Toledo, Autochem, Inc., Redmond, Washington, USA.
Rukman De SilvaU.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Dean RippleNational Institute of Standards and Technology, Gaithersburg, Maryland, 20899, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The phase-appropriate application of analytical methods to characterize, monitor, and control particles is an important aspect of the development of safe and efficacious biotherapeutics. The AAPS Product Attribute and Biological Consequences (PABC) focus group (which has since transformed into an AAPS community) conducted a survey where participating labs rated their method of choice to analyze protein aggregation/particle formation during the different stages of the product life cycle. The survey confirmed that pharmacopeial methods and SEC are the primary methods currently applied in earlier phases of the development to ensure that a product entering clinical trials is safe and efficacious. In later phases, additional techniques are added including those for non-GMP extended characterization for product and process characterization. Finally, only robust, globally-accepted, and stability-indicating methods are used for GMP quality control purposes. This was also consistent with the feedback during a webinar hosted by the group to discuss the survey results. In this white paper, the team shares the results of the survey and provides guidance on selecting phase-appropriate analytical methods and developing a robust particle control strategy.

Indexed as

Drug DevelopmentQuality ControlBiological ProductsParticulate MatterBiological ProductsParticulate Matterbiotechcontrol strategydrug productprotein aggregationsubvisible particles

Identifiers

PMID31677011

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.