GMP Biomanufacturing Learning Pathway

Aseptic Practices and Biologics 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

Aseptic Practices & Biologics Manufacturing Monoclonal Antibody (mAB) Focus

This training is intended for individuals seeking to enhance their understanding of industry standards, regulated manufacturing environments, and proficiency in aseptic techniques. It offers a valuable opportunity for those with experience in lab-scale biomanufacturing, enabling them to deepen their knowledge of real-world manufacturing environments.

3-day intensive Hands-on lab training 3 CASTL locations
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 — GMP/GDP & Contamination Control

  • Contamination control and cleanroom classification
  • Gowning and cleanroom cleaning
  • GMP recap and ALCOA+ documentation principles

Day 2 — Buffer & Solution Prep in a GMP Environment

  • Buffer preparation according to GDP
  • Filter integrity testing
  • Aseptic practices

Day 3 — Biomanufacturing Process Overview (mAB)

  • Upstream processing
  • Downstream processing
  • Fill-finish overview
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

Gowning & Cleanroom Conduct

Execute gowning practices and perform cleanroom cleaning activities consistent with contamination control principles.

Buffer Prep

Buffer & Solution Preparation

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

Aseptic

Aseptic Practices

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

Filtration

Filter Integrity Testing

Perform and interpret filter integrity testing at a foundational level within a manufacturing workflow.

Process Flow

Upstream to Fill-Finish

Describe and contextualize upstream, downstream, and fill-finish stages within the overall biomanufacturing 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.