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Genomics02:02

Genomics

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Genomics is the science of genomes: it is the study of all the genetic material of an organism. In humans, the genome consists of information carried in 23 pairs of chromosomes in the nucleus, as well as mitochondrial DNA. In genomics, both coding and non-coding DNA is sequenced and analyzed. Genomics allows a better understanding of all living things, their evolution, and their diversity. It has a myriad of uses: for example, to build phylogenetic trees, to improve productivity and...
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DNA sequencing is a fundamental technique that is routinely used in the biological sciences. This method can be applied to a range of questions at different scales - from the sequencing of a cloned DNA fragment or the study of a mutation in a gene up to whole-genome sequencing. However, despite the widespread use of sequencing today, it was not until 1977 that Fredrick Sanger and his collaborators developed the chain-termination method to decode DNA sequences. It relies on the separation of a...
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The first human genome sequencing project cost $2.7 billion and was declared complete in 2003, after 15 years of international cooperation and collaboration between several research teams and funding agencies. Today, with the advent of next-generation sequencing technologies, the cost and time of sequencing a human genome have dropped over 100 fold.
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Synthetic Biology02:55

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Synthetic biology is an interdisciplinary science that involves using principles from disciplines such as engineering, molecular biology, cell biology, and systems biology. It involves remodeling existing organisms from nature or constructing completely new synthetic organisms for applications such as protein or enzyme production, bioremediation, value-added macromolecule production, and the addition of desirable traits to crops, to name a few.
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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Quality Assurance01:19

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Building a Quality Management System in a Core Facility: A Genomics Core Case Study.

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Implementing a quality management system (QMS) in academic core facilities enhances research rigor and reproducibility. This systematic approach, based on ISO 9001, improves operations and opens new funding avenues for core labs.

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Area of Science:

  • Biomedical Research Infrastructure
  • Laboratory Management
  • Genomics

Background:

  • Core facilities are essential academic research resources providing advanced technologies and expertise.
  • Recharge models and dynamic research landscapes necessitate robust quality control in core labs.
  • A quality management system (QMS) is a key differentiator for ensuring rigorous and reproducible research.

Purpose of the Study:

  • To describe a systematic approach for establishing a QMS in an academic genomics core facility.
  • To provide practical, step-by-step recommendations for implementing a QMS in core facilities.
  • To demonstrate the general applicability of the QMS model across diverse academic core facilities.

Main Methods:

  • The QMS model is based on International Organization for Standardization (ISO) 9001 principles.
  • Key initiatives include process mapping, comprehensive training, standard operating procedures (SOPs), and quality audits.
  • Methods for continuous improvement involve root cause analysis, visual controls, mock audits, metrics tracking, and customer feedback.

Main Results:

  • Implementation of the QMS led to improved operational efficiency and research quality within the genomics core.
  • The QMS framework facilitated compliance with good laboratory practices (GLP).
  • The core facility became qualified to pursue federally funded contracts, diversifying projects and revenue streams.

Conclusions:

  • A systematic QMS is crucial for academic core facilities to maintain competitiveness and ensure research integrity.
  • Adoption of GLP principles through a QMS fosters collaboration with pharmaceutical and federal research partners.
  • Implementing a QMS enhances a core facility's capabilities, leading to broader funding opportunities and revenue diversification.