GMP Biomanufacturing Learning Pathway

Aseptic Cell Culture Basics

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

Aseptic Cell Culture Basics GMP-Simulated Setting

This training is designed for individuals seeking to enhance their proficiency in aseptic processing techniques and mammalian cell culture. It offers a valuable opportunity for those aspiring to transition into the biomanufacturing sector, enabling them to deepen their knowledge and align with industry standards and expectations. No prior cell culture experience required.

3-day intensive Hands-on lab training Guelph, ON
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 For participants travelling 2+ hours to the training site.
01 — Schedule

3-day training agenda

Day 1 — Foundations & GMP

  • Introduction to GMP standards
  • Aseptic processing fundamentals
  • Basic lab skills orientation
  • Working with cells and equipment

Day 2 — Techniques & Documentation

  • Core cell culture techniques
  • Cleanroom readiness and gowning
  • Proper documentation practices
  • GDP in practice

Day 3 — Applied Practice & Careers

  • Practical skills application exercises
  • Documentation and batch record review
  • Biomanufacturing career exploration
  • Post-training self-assessment
02 — Learning Outcomes

What you will be able to do

GMP

GMP Requirements

Discuss GMP requirements and expectations in biomanufacturing and advanced therapy manufacturing contexts.

GDP

GDP & Data Integrity

Apply GDP using batch records and explain data integrity principles including the ALCOA+ framework.

Cleanroom

Cleanroom Activities

Demonstrate cleanroom procedures, aseptic gowning, and describe cleanroom-specific job roles and career pathways.

Aseptic

Aseptic Technique

Demonstrate safe and correct use of a BSC in graded environments and apply First Air Principles with open vessels.

Cell Banking

Cell Bank Operations

Perform common unit operations used to generate cell banks in an industry-standard biomanufacturing environment.

Equipment

Equipment & Career Readiness

Use automated equipment such as the Nucleocounter and assess personal skill development for cleanroom careers.

03 — Pre-Requisites

Mandatory self-paced courses before arrival

(Course access provided upon acceptance.)

Safety

Lab Safety & Biosafety

Foundation safety principles for laboratory and biological environments — mandatory before in-person training begins.

Regulatory

Introduction to GMP & Regulatory

Overview of Good Manufacturing Practice requirements and the regulatory framework governing biomanufacturing.

Documentation

Fundamentals of GDP

Core principles of Good Documentation Practice including data integrity, batch records, and ALCOA+ standards.

Technique

Aseptic Processing

Introduction to aseptic technique principles — foundational knowledge required for all in-person lab work.

Monitoring

Environmental Monitoring

Introduction to environmental monitoring programs, sampling methodologies, and alert and action limits in cleanroom settings.