Evidence map›Paper›PMID 38937372›Full record

ReviewPharmaceutical research2024

Stability of Protein Pharmaceuticals: Recent Advances.

Mark Cornell Manning, Ryan E Holcomb, Robert W Payne, Joshua M Stillahn, Brian D Connolly, Derrick S Katayama, Hongcheng Liu, James E Matsuura, Brian M Murphy, Charles S Henry and 1 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

17 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. 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

11 authors.

Mark Cornell ManningLegacy BioDesign LLC, Johnstown, CO, USA. manning@legacybiodesign.com.
Ryan E HolcombLegacy BioDesign LLC, Johnstown, CO, USA.
Robert W PayneLegacy BioDesign LLC, Johnstown, CO, USA.
Joshua M StillahnLegacy BioDesign LLC, Johnstown, CO, USA.
Brian D ConnollySpyre Therapeutics, Inc., Waltham, MA, USA.
Derrick S KatayamaSamsung Biologics, 201-2, Songdo-Dong, Yeonsu-Gu, Incheon, Korea.
Hongcheng LiuScholar Rock, Inc., Cambridge, MA, USA.
James E MatsuuraJim Matsuura Pharma Consulting LLC, Lafayette, CO, USA.
Brian M MurphyJust-Evotec, Seattle, WA, USA.
Charles S HenryDepartment of Chemistry, Colorado State University, Fort Collins, CO, USA.
Daan J A CrommelinUtrecht University, Utrecht, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There have been significant advances in the formulation and stabilization of proteins in the liquid state over the past years since our previous review. Our mechanistic understanding of protein-excipient interactions has increased, allowing one to develop formulations in a more rational fashion. The field has moved towards more complex and challenging formulations, such as high concentration formulations to allow for subcutaneous administration and co-formulation. While much of the published work has focused on mAbs, the principles appear to apply to any therapeutic protein, although mAbs clearly have some distinctive features. In this review, we first discuss chemical degradation reactions. This is followed by a section on physical instability issues. Then, more specific topics are addressed: instability induced by interactions with interfaces, predictive methods for physical stability and interplay between chemical and physical instability. The final parts are devoted to discussions how all the above impacts (co-)formulation strategies, in particular for high protein concentration solutions.'

Indexed as

Drug StabilityProteinsProtein StabilityAnimalsAntibodies, MonoclonalChemistry, PharmaceuticalDrug CompoundingExcipientsHumansAntibodies, MonoclonalExcipientsProteinsco-formulationformulationmonoclonal antibodiesproteinsprotein stability

Identifiers

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.