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Formulation Considerations for Autologous T Cell Drug Products - PubMed
Source: pubmed.ncbi.nlm.nih.gov
Article summary:
1. This review discusses the unique challenges posed by the manufacture of chimeric antigen receptor (CAR) and αβ-T cell receptor (TCR) transduced T cells, including formulation, cryopreservation and fill-finish steps.
2. It compares the formulation design and presentation for administration of CAR-T cell therapies, as well as discussing automated formulation and fill-finish processes, the formulation design space, Monte Carlo simulation applied to risk analysis, primary container selection, freezing profiles and thawing.
3. The review also looks at the use of dimethyl sulfoxide and alternative solvents/excipients as cryopreservation agents in order to meet simplification of manufacture and flexibility in dosage form for clinical treatment.
Article analysis:
The article is generally trustworthy and reliable due to its comprehensive coverage of the topic. It provides a detailed overview of the challenges posed by manufacturing autologous T cell drug products, such as CAR-T cell therapies, with an emphasis on formulation considerations. The authors provide a thorough discussion on topics such as automated formulation and fill-finish processes, design space exploration, risk analysis using Monte Carlo simulations, primary container selection, freezing profiles and thawing techniques. Furthermore, they discuss potential solutions to simplify manufacture while providing flexibility in dosage form for clinical treatment.
The article does not appear to have any biases or one-sided reporting; it presents both sides equally without any promotional content or partiality. All possible risks are noted throughout the article where applicable. The authors provide evidence for their claims through references to relevant studies and research papers which adds credibility to their arguments. There are no unsupported claims or missing points of consideration that could undermine its reliability or trustworthiness.