Evidence map›Paper›PMID 28795351›Full record

ReviewThe AAPS journal2017

Advancements in Understanding Immunogenicity of Biotherapeutics in the Intraocular Space.

Eric Wakshull, Valerie Quarmby, Hanns-Christian Mahler, Hongwen Rivers, Dhananjay Jere, Meg Ramos, Piotr Szczesny, Karoline Bechtold-Peters, Sharmila Masli, Swati Gupta

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.0field-weighted citation impact, top 9% 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

10 citing papers in PubMed, 26 citations in OpenAlex.

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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

10 authors at 8 institutions in 3 countries.

Eric WakshullBioAnalytical Sciences Genentech, South San Francisco, California, USA.
Valerie QuarmbyBioAnalytical Sciences Genentech, South San Francisco, California, USA.
Hanns-Christian MahlerLonza, Drug Product Services, Basel, Switzerland.
Hongwen RiversDrug Delivery, Allergan, Irvine, California, USA.
Dhananjay JereLonza, Drug Product Services, Basel, Switzerland.
Meg RamosAbbVie, Preclinical Safety, North Chicago, Illinois, USA.
Piotr SzczesnyPDS-Lead, F. Hoffmann-La Roche AG, Basel, Switzerland.
Karoline Bechtold-PetersNovartis Pharma AG, Basel, Switzerland.
Sharmila MasliBoston University, Boston, Massachusetts, USA.
Swati GuptaNonclinical and Translational Sciences, Allergan, Irvine, California, USA. gupta_swati@allergan.com.ORCID 0000-0003-4559-4984
Bioanalytical Systems (United States) · USLonza (Switzerland) · CHAbbVie (United States) · USAllergan (Ireland) · IEAllergan (United States) · USBoston University · USNovartis (Switzerland) · CHRoche (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Therapeutic breakthroughs in a number of retinal degenerative diseases have come about through the development of biotherapeutics administered directly into the eye. As a consequence of their use, we have gained more insight into the immune privileged status of the eye and the various considerations that development, manufacturing, and use of these drugs require. It has been observed that therapeutic proteins injected into the vitreous can elicit an immune response resulting in the production of anti-drug antibodies (ADAs) which can have clinical consequences. This review includes discussion of the anatomy, physiology, and specific area of the eye that are targeted for drug administration. The various immunologic mechanisms involved in the immune responses to intraocularly administered protein are discussed. This review entails discussion on chemistry, manufacturing, and control (CMC) and formulation-related issues that may influence the risk of immunogenicity. Based on the available immunogenicity profile of the marketed intraocular drugs and their reported adverse events, the animal models and the translational gap from animals to human are discussed. Thus, the objective of this review article is to assess the factors that influence immunogenicity in relation to intraocular administration and the steps taken for mitigating immunogenicity risks.

Indexed as

Biological TherapyAnimalsBiological ProductsEye DiseasesHumansBiological Productsimmunogenicityintraocular administrationocular biotherapeutics

Identifiers

PMID28795351
OpenAlexW2743669077

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.