Evidence map›Paper›PMID 33479640›Full record

ReviewRSC medicinal chemistry2020

Production of biomedical cell products: requirements for the quality of donor material and excipients of animal origin (review).

Marina A Vodiakova, Aliya R Sayfutdinova, Ekaterina V Melnikova, Artem A Goryaev, Natalia P Sadchikova, Vladimir I Gegechkori, Vadim A Merkulov

Open access · greenAbstract readReview
In one paragraph

Review in RSC medicinal chemistry, 2020. 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
0.2field-weighted citation impact, top 46% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

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 at 3 institutions in 1 country.

Marina A VodiakovaFSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Aliya R SayfutdinovaFSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Ekaterina V MelnikovaFSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Artem A GoryaevFSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Natalia P SadchikovaI.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) , 119991 Moscow , Russia . Email: vgegechkori@gmail.com.
Vladimir I GegechkoriI.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) , 119991 Moscow , Russia . Email: vgegechkori@gmail.com.
Vadim A MerkulovFSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation , Moscow , 127051 , Russia.
Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" · RUSechenov University · RUMinistry of Health of the Russian Federation · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Donor biological materials and excipients of animal origin are important components in the production of biomedical cell products (BMCPs). Their quality ensures the stability, safety, effectiveness and purity of the final product. This review discusses quality requirements for biological excipients intended for the production of biomedical cell products, in terms of the necessary information that should be included in the BMCP registration dossier during state registration and is subject to expert assessment during quality control. Considering that there is currently no production of biomedical cell products in the Russian Federation, the authors considered international approaches to ensuring the safety of donor material and excipients for the manufacturing of human cell- and tissue-based products (BMCP analogues).

Identifiers

PMID33479640
PMCPMC7580781
OpenAlexW3008986299

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.