April 1, 2026

CRISPR-Cas9 Experiment Design and Validation for Biomanufacturing

Instructor: Kaitlin M. Dailey, PhD, URI

Location: URI

Session 1: June 15-17 (Room 303)

Session 2: June 24-26 (Room 303)

Course Overview

This workforce development workshop module was designed to strengthen Rhode Island’s biomanufacturing talent pipeline by providing participants with applied, industry‑relevant training in CRISPR‑Cas9 experiment design and validation. The workshop emphasizes how genome-editing technologies are used in modern biomanufacturing workflows, including strain engineering, process optimization, quality control, and product consistency. Participants will be guided through the full experimental lifecycle, from target identification and guide RNA design to control selection, validation strategies, and data interpretation, with a strong focus on reproducibility, scalability, and regulatory awareness – core competencies required in biomanufacturing and translational research environments.

The module highlights validation approaches critical to biomanufacturing contexts, including genotypic confirmation, phenotypic screening, off‑target risk assessment, and documentation practices aligned with quality systems and good laboratory/manufacturing principles. Case studies and applied design exercises connect CRISPR decision‑making to downstream manufacturing considerations such as yield stability, process robustness, and technology transfer. By emphasizing experimental rigor, the workshop will equip participants with transferable skills directly relevant to roles in biotech industries.

This workshop directly supports Rhode Island’s life sciences and biomanufacturing workforce priorities by developing core biotechnical competencies. At the national level, the training aligns with federal workforce development goals to strengthen domestic biomanufacturing capacity and expand the skilled technical workforce. By connecting foundational genome-editing knowledge to real-world manufacturing applications, the workshop contributes to an innovation-ready workforce capable of supporting both near-term industry needs and long-term national bioeconomy objectives.

Learning Outcomes

  • Apply CRISPR‑Cas9 genome editing principles to biomanufacturing‑relevant contexts by designing gene‑editing experiments that account for strain engineering goals, process robustness, reproducibility, and downstream manufacturing considerations.
  • Implement appropriate validation and quality‑control strategies—including genotypic confirmation, phenotypic assessment, off‑target risk evaluation, and documentation practices—aligned with biomanufacturing standards and quality‑driven laboratory and production environments.
  • Translate genome‑editing design decisions into workforce‑ready competencies by connecting experimental planning and data interpretation to scalability, regulatory awareness, and technology transfer needs across biotechnology and biomanufacturing sectors.

Lab Report

Students will be expected to:

  • Maintain clear, accurate, and contemporaneous laboratory notebooks that document experimental objectives, protocols, materials, conditions, deviations, and observations in sufficient detail to support reproducibility and troubleshooting.
  • Record data and results systematically, including raw data, calculations, controls, and validation outcomes, using standardized formats and clear labeling consistent with laboratory and biomanufacturing best practices.
  • Design and validate a genetic modification and perform the initial steps in vitro to implement the schematic.

Resources Used in this Module

  • Standard Operating Procedures – DNA extraction methods, PCR, restriction digest, ligation, plasmid generation and cloning.
  • SerialCloner software for in silico experimental design and validation
  • Microsoft Powerpoint slide decks for lectures

Proposed Timeline (Subject to Change)

Day 1Day 2Day 3
8:30 AM – 9:00 AMWelcome, safety and workforce framingDay 2 briefingResult synthesis and communication
9:00 AM – 10:30 AMGenetic engineering and CRISPR-Cas9 foundationsSupervised Benchwork: genetic engineering executionBiomanufacturing and workforce alignment
10:30 AM – 10:45 AMBreakSupervised Benchwork: genetic engineering executionBreak
10:45 AM – 12:15 PMCRISPR experiment design (design thinking)Supervised Benchwork: genetic engineering executionReflection, assessment and next steps. This will occur from 11:00 AM – 12:30 PM.
12:15 PM – 1:00 PMLunchLunch
1:00 PM – 2:30 PMLaboratory documentation and data planningBenchwork validation and initial analysis
2:30 PM – 2:45 PMBreakBreak
2:45 PM – 4:30 PMBenchwork orientation and pre-lab activitiesData Interpretation & Quality Thinking