Evidence map›Paper›PMID 32430594›Full record

ReviewMethods in molecular biology (Clifton, N.J.)2021

Addressing Manufacturing Challenges for Commercialization of iPSC-Based Therapies.

Mehdi Dashtban, Krishna Morgan Panchalingam, Mehdi Shafa, Behnam Ahmadian Baghbaderani

Abstract readReview
PubMed Publisher
In one paragraph

Review in Methods in molecular biology (Clifton, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

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  12. Advances in Manufacturing Cardiomyocytes from Human Pluripotent Stem Cells.Annual review of chemical and biomolecular engineering · 2022
    Review
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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

4 authors.

Mehdi DashtbanCell Therapy Process Department, Lonza Houston, Inc., Houston, TX, USA.
Krishna Morgan PanchalingamCell Therapy Process Department, Lonza Houston, Inc., Houston, TX, USA.
Mehdi ShafaCell Therapy Process Department, Lonza Houston, Inc., Houston, TX, USA.
Behnam Ahmadian BaghbaderaniCell Therapy Process Department, Lonza Houston, Inc., Houston, TX, USA. behnam.ahmadianbaghbaderani@lonza.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of reprogramming technology to generate human induced pluripotent stem cells (iPSCs) has tremendously influenced the field of regenerative medicine and clinical therapeutics where curative cell replacement therapies can be used in the treatment of devastating diseases such as Parkinson's disease (PD) and diabetes. In order to commercialize these therapies to treat a large number of individuals, it is important to demonstrate the safety and efficacy of these therapies and ensure that the manufacturing process for iPSC-derived functional cells can be industrialized at an affordable cost. However, there are a number of manufacturing obstacles that need to be addressed in order to meet this vision. It is important to note that the manufacturing process for generation of iPSC-derived specialized cells is relatively long and fairly complex and requires differentiation of high-quality iPSCs into specialized cells in a controlled manner. In this chapter, we have summarized our efforts to address the main challenges present in the industrialization of iPSC-derived cell therapy products with focus on the development of a current Good Manufacturing Practice (cGMP)-compliant iPSC manufacturing process, a comprehensive iPSC characterization platform, long-term stability of cGMP compliant iPSCs, and innovative technologies to address some of the scale-up challenges in establishment of iPSC processing in 3D computer-controlled bioreactors.

Indexed as

CommodificationBiomedical TechnologyHumansInduced Pluripotent Stem CellsPractice Guidelines as TopicRegenerative Medicine3D computer-controlled bioreactorsCell therapycGMPCommercializationInduced pluripotent stem cellsProcess development

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.