GMP Biomanufacturing Learning Pathway

mRNA and mRNA-LNP Manufacturing

Entrepreneurship Bootcamp Timeline
Pre-training
Assessment, orientation,
access to preparatory material
and support (virtual)
In Lab Training
Hands-on laboratory work,
practical skills,
interactive case studies
(in person)
Post-training
Assessment and
Action Plan
(virtual)
Networking
Making new connections.
Follow-up
Program Impact
Survey
(virtual)
Total: 40h
Biomanufacturing Learning Pathway

mRNA and mRNA-LNP Manufacturing mRNA and mRNA-LNP Process Focus

This training is intended for individuals seeking to enhance their understanding of industry standards, regulated manufacturing environments and mRNA/mRNA-LNP production workflow from upstream to fill and finish.

3-day intensive Hands-on lab training Montreal
Go to the BioHubNet Training Platform
To enroll
  1. 01 Apply for ENGAGE Training Credits on the BioHubNet Training Platform If you are not already enrolled in the BioHubNet ENGAGE program
  2. 02 Request to Enroll on the Training Platform under the Training Marketplace (under special programs)
Travel & accommodation support Available for eligible participants travelling to a CASTL training site.
Assessment & instructor support Instructor-led assessment of practical skills, plus knowledge checks for the on-demand components.
01 — Schedule

3-day training agenda

Day 1 — mRNA Intro & Cleanroom Foundations

  • Introduction to mRNA manufacturing
  • Contamination control and cleanroom classification
  • Grade C gowning
  • Buffer preparation

Day 2 — Transcription & Aseptic Processing

  • mRNA manufacturing: linearization, transcription, and capping
  • Aseptic techniques
  • UF/DF in mRNA manufacturing

Day 3 — Purification, LNP & Fill-Finish

  • Chromatography in mRNA manufacturing
  • LNP encapsulation
  • Fill and finish
02 — Learning Outcomes

What you will be able to do

GMP/GDP

GMP & GDP Foundations

Apply foundational GMP and GDP concepts in a controlled training environment, and apply ALCOA+ principles to documentation and activity recording during practical exercises.

Contamination

Contamination Control

Demonstrate contamination control behaviours aligned to cleanroom expectations and overall contamination risk awareness.

Cleanroom

Buffer Preparation in Pilot Scale

Prepare buffers and solutions following a GDP-aligned workflow discipline in a GMP-simulated environment.

Workflow

GDP Workflow Discipline

Follow a GDP-aligned workflow discipline across practical exercises in a GMP-simulated environment.

Aseptic

Aseptic Practices

Demonstrate foundational aseptic practices and contamination risk awareness when working with open systems.

Process Flow

Upstream to Fill-Finish

Describe and contextualize upstream, downstream, and fill-finish stages within the overall mRNA process flow.

03 — Pre-Requisites

Mandatory on-demand courses before arrival

Course access provided upon acceptance.

Regulatory

Introduction to GMP & QA/QC

Overview of Good Manufacturing Practice and the quality assurance and quality control functions governing biomanufacturing.

Lectures

Preparatory Lectures

Establish shared technical context and improve safety, readiness, and facility familiarity.