Evidence map›Paper›PMID 40838463›Full record

ArticleBiotechnology and bioengineering2025

Accelerated Adeno Associated Virus Upstream Process Development From High-Throughput Systems to Clinical Scale.

Angela Andaluz, Brittany Monteverde, Kevin Vera, Brandon Tse, Ivan Gajic, Clifford Forelich, Seyed Pouria Motevalian

Erratum issuedAbstract read
In one paragraph

Article in Biotechnology and bioengineering, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. In Vivo T-Cell Engineering: Revolution in Delivery Strategies and Clinical Translation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  3. Exploring gene editing as a potential therapeutic strategy for hemophilia.Frontiers in bioengineering and biotechnology · 2026
    Review
  4. Cascade Oxygen Control Enhances Growth ofPlants (Basel, Switzerland) · 2025
    Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Angela AndaluzBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.
Brittany MonteverdeBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.
Kevin VeraBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.
Brandon TseBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.
Ivan GajicBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.
Clifford ForelichBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.
Seyed Pouria MotevalianBioProcess Sciences, Pharma Services, Viral Vector Services, Thermo Fisher Scientific, Plainville, Massachusetts, USA.ORCID https://orcid.org/0000-0003-3768-789X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adeno-associated virus (AAV) is one of the most common delivery systems used in gene therapy. Challenges in the development and manufacturing of AAVs include high cost of goods (COGs) per dose, process scalability, speed to market, and process-related impurities such as empty capsids. This article presents a streamlined approach to developing and scaling AAV upstream production process via triple transfection from bench scale to commercial volumes exceeding 1,000 L. By leveraging high-throughput technologies such as the AMBR®15 system, we achieved rapid upstream process development in under 2 months. These tools enabled optimization of productivity, impurity reduction, and COGs per dose. We also detail methodologies for direct scale-up from AMBR®15 to a 2,000 L single-use production bioreactor.

Indexed as

BioreactorsDependovirusGenetic VectorsHigh-Throughput Screening AssaysGenetic TherapyHumansTransfectionadeno‐associated viruscost of good reductiongene therapyhigh throughput developmentscale uptransfection

Identifiers

PMID40838463
PMCPMC12503008

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.