Evidence map›Paper›PMID 34323013›Full record

ArticleBiotechnology progress2021

Microfluidic chip-based single-cell cloning to accelerate biologic production timelines.

Jonathan Diep, Huong Le, Kim Le, Ewelina Zasadzinska, Jasmine Tat, Pheng Yam, Ryan Zastrow, Natalia Gomez, Jennitte Stevens

Open access · greenAbstract read
In one paragraph

Article in Biotechnology progress, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

9 authors at 1 institution in 1 country.

Jonathan DiepDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.ORCID 0000-0003-3876-2126
Huong LeDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.
Kim LeDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.ORCID 0000-0001-6626-5202
Ewelina ZasadzinskaDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.
Jasmine TatDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.
Pheng YamDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.
Ryan ZastrowDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.
Natalia GomezDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.ORCID 0000-0002-4246-9304
Jennitte StevensDrug Substance Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, California, USA.ORCID 0000-0002-4081-4696
Amgen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cell line development (CLD) represents a critical, yet time-consuming, step in the biomanufacturing process as significant resources are devoted to the scale-up and screening of several hundreds to thousands of single-cell clones. Typically, transfected pools are fully recovered from selection and characterized for growth, productivity, and product quality to identify the best pools suitable for single-cell cloning (SCC) using limiting dilution or fluorescence-activated cell sorting (FACS). Here we report the application of the Berkeley Lights Beacon Instrument (BLI) in an early SCC process to accelerate the CLD timeline. Transfected pools were single-cell cloned when viabilities reached greater than 85% or during selection when viabilities were less than 30%. Clones isolated from these accelerated processes exhibited comparable growth, productivity, and product quality to those derived from a standard CLD process and fit into an existing manufacturing platform. With these approaches, up to a 30% reduction in the overall CLD timeline was achieved. Furthermore, early process-derived clones demonstrated equivalent long-term stability compared with standard process-derived clones over 50 population doubling levels (PDLs). Taken together, the data supported early SCC on the BLI as an attractive approach to reducing the standard CLD timeline while still identifying clones with acceptable manufacturability.

Indexed as

Lab-On-A-Chip DevicesAnimalsCHO CellsCloning, MolecularCricetinaeCricetulusFlow CytometryHumansImmunoglobulin GMicrofluidic Analytical TechniquesRecombinant Fusion ProteinsSingle-Cell AnalysisImmunoglobulin GRecombinant Fusion ProteinsBerkeley Lights Instrumentcell line developmentsingle-cell cloningspeed-to-markettimeline

Identifiers

PMID34323013
PMCPMC9285370
OpenAlexW3183653618

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.