Activity
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Thrilled to be representing Breakout Ventures at BioVenture Nexus 2024 on October 3-4 at the JW Marriott - The Ritz Carlton, Los Angeles! This…
Thrilled to be representing Breakout Ventures at BioVenture Nexus 2024 on October 3-4 at the JW Marriott - The Ritz Carlton, Los Angeles! This…
Liked by Sara Mills
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Please join my team and I as we discuss questions related to late stage IND CMC readiness for cell therapy and tissue engineering products!
Please join my team and I as we discuss questions related to late stage IND CMC readiness for cell therapy and tissue engineering products!
Liked by Sara Mills
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I'm looking forward to the 9th CAR-TCR Summit in Boston this September! Let me know if you're attending! #CARTCR CAR-TCR Summit Series
I'm looking forward to the 9th CAR-TCR Summit in Boston this September! Let me know if you're attending! #CARTCR CAR-TCR Summit Series
Liked by Sara Mills
Volunteer Experience
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President
San Diego Juvenile Diabetes Research Foundation Young Leadership Committee
- 3 years 9 months
Health
The JDRF San Diego Young Leadership Committee (YLC) is a group of young professionals who are actively involved with JDRF and are dedicated to JDRF's mission to cure, treat and prevent type 1 diabetes (T1D).
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Vice President
San Diego Juvenile Diabetes Research Foundation Young Leadership Committee
- 1 year 6 months
Health
Publications
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Process evolution in cell and gene therapy from discovery to commercialization
The Canadian Journal of Engineering
The field of cell and gene therapy (CGT) is maturing at a rapid rate. Manufacturing remains a major challenge and manufacturing failures and limitations are a notable source of CGT products not meeting specification or being held back from regulatory approvals. To ensure that products remain compliant and competitive throughout their lifecycle, CGT process development requires both ongoing advancement of fit-for-purpose technologies to allow for and support well-designed development studies…
The field of cell and gene therapy (CGT) is maturing at a rapid rate. Manufacturing remains a major challenge and manufacturing failures and limitations are a notable source of CGT products not meeting specification or being held back from regulatory approvals. To ensure that products remain compliant and competitive throughout their lifecycle, CGT process development requires both ongoing advancement of fit-for-purpose technologies to allow for and support well-designed development studies, and a methodology that enables these studies to occur effectively during focused product development campaigns. We describe a framework for ongoing innovation in CGT process development, manufacturing, and clinical testing, based on the quality by design (QbD) approach. We propose use of the concepts of process discovery, process characterization, and process development in an iterative way to refine the design space as a product matures. This strategy is enabled by the early implementation of broad and robust analytics, and a modular approach to accelerate optimization. With these strategies, CGT developers can prospectively plan for comparability studies and develop in a stage-appropriate manner, to allow for ongoing innovation and improvements from discovery through to commercialization.
Other authorsSee publication -
Incomplete DNA methylation underlies a transcriptional memory of the somatic cell in human iPS cells
Nature Cell Biology
Human induced pluripotent stem (iPS) cells are remarkably similar to embryonic stem (ES) cells, but recent reports indicate that there may be important differences between them. We carried out a systematic comparison of human iPS cells generated from hepatocytes (representative of endoderm), skin ?broblasts (mesoderm) and melanocytes (ectoderm). All low-passage iPS cells analysed retain a transcriptional memory of the original cells. The persistent expression of somatic genes can be partially…
Human induced pluripotent stem (iPS) cells are remarkably similar to embryonic stem (ES) cells, but recent reports indicate that there may be important differences between them. We carried out a systematic comparison of human iPS cells generated from hepatocytes (representative of endoderm), skin ?broblasts (mesoderm) and melanocytes (ectoderm). All low-passage iPS cells analysed retain a transcriptional memory of the original cells. The persistent expression of somatic genes can be partially explained by incomplete promoter DNA methylation. This epigenetic mechanism underlies a robust form of memory that can be found in iPS cells generated by multiple laboratories using different methods, including RNA transfection. Incompletely silenced genes tend to be isolated from other genes that are repressed during reprogramming, indicating that recruitment of the silencing machinery may be inefficient at isolated genes. Knockdown of the incompletely reprogrammed gene C9orf64 (chromosome 9 open reading frame 64) reduces the ?efficiency of human iPS cell generation, indicating that somatic memory genes may be functionally relevant during reprogramming.
Other authorsSee publication -
Comparison of sequencing-based methods to profile DNA methylation and identification of monoallelic epigenetic modifications
Nature Biotechnology
Analysis of DNA methylation patterns relies increasingly on sequencing-based profiling methods. The four most frequently used sequencing-based technologies are the bisulfite-based methods MethylC-seq and reduced representation bisulfite sequencing (RRBS), and the enrichment-based techniques methylated DNA immunoprecipitation sequencing (MeDIP-seq) and methylated DNA binding domain sequencing (MBD-seq). We applied all four methods to biological replicates of human embryonic stem cells to assess…
Analysis of DNA methylation patterns relies increasingly on sequencing-based profiling methods. The four most frequently used sequencing-based technologies are the bisulfite-based methods MethylC-seq and reduced representation bisulfite sequencing (RRBS), and the enrichment-based techniques methylated DNA immunoprecipitation sequencing (MeDIP-seq) and methylated DNA binding domain sequencing (MBD-seq). We applied all four methods to biological replicates of human embryonic stem cells to assess their genome-wide CpG coverage, resolution, cost, concordance and the influence of CpG density and genomic context. The methylation levels assessed by the two bisulfite methods were concordant (their difference did not exceed a given threshold) for 82% for CpGs and 99% of the non-CpG cytosines. Using binary methylation calls, the two enrichment methods were 99% concordant and regions assessed by all four methods were 97% concordant. We combined MeDIP-seq with methylation-sensitive restriction enzyme (MRE-seq) sequencing for comprehensive methylome coverage at lower cost. This, along with RNA-seq and ChIP-seq of the ES cells enabled us to detect regions with allele-specific epigenetic states, identifying most known imprinted regions and new loci with monoallelic epigenetic marks and monoallelic expression.
Other authors
More activity by Sara
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Interesting article on gene-editing strategies for allogeneic iPSC cell therapies from our expert, VP of Cell Line Development, Suzanne Snellenberg!…
Interesting article on gene-editing strategies for allogeneic iPSC cell therapies from our expert, VP of Cell Line Development, Suzanne Snellenberg!…
Liked by Sara Mills
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Looking forward to attend CAR-TCR with my OmniaBio colleagues next month. Let's schedule time to meet!
Looking forward to attend CAR-TCR with my OmniaBio colleagues next month. Let's schedule time to meet!
Liked by Sara Mills
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Chimeric Therapeutics is featured in Stockhead's 'Health & Biotech' Investor Guide, spotlighting our work in CAR-T therapies. Under the leadership of…
Chimeric Therapeutics is featured in Stockhead's 'Health & Biotech' Investor Guide, spotlighting our work in CAR-T therapies. Under the leadership of…
Liked by Sara Mills
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The journey of Cal Poly Humboldt CIRM Bridges Intern Joshua Nelson is an inspiration to all interested in dedicating their lives to supporting…
The journey of Cal Poly Humboldt CIRM Bridges Intern Joshua Nelson is an inspiration to all interested in dedicating their lives to supporting…
Liked by Sara Mills
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Today, we announced exciting updates to the growing team at 4DMT, including new additions to our #leadership team, strengthening 4DMT’s large market…
Today, we announced exciting updates to the growing team at 4DMT, including new additions to our #leadership team, strengthening 4DMT’s large market…
Liked by Sara Mills
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