About
CASTL courses

Introduction to Bioprocessing (Onsite)

Introduction to Bioprocessing introduces the biopharmaceutical industry and its associated processing principles and techniques to individuals looking to enhance their knowledge of the industry. This on-site training is delivered on the floor of CASTL Biomanufacturing Training Facility allowing attendees an up-close and personal tour of the equipment used in upstream, downstream and fill finish processes.

Who should take this course?
Anyone working in the biopharmaceutical and related industries who wish to further their understanding of all aspects of biopharmaceutical manufacturing.

Delivery
Onsite at a CASTL Biomanufacturing Training Facility.

View our training calendar to register for this course

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Introduction to Bioprocessing (Virtual)

Introduction to Bioprocessing introduces the biopharmaceutical industry and its associated processing principles and techniques to individuals looking to enhance their knowledge of the industry. This online theory course provides an overview of industry processes including upstream, downstream, and fill finish operations. The course also includes an interactive virtual tour of the award-winning and globally recognized National Institute for Bioprocessing Research and Training (NIBRT) Pilot Plant Facility.

Who should take this course?
Anyone working in the biopharmaceutical and related industries who wish to further their understanding of all aspects of biopharmaceutical manufacturing.

Delivery
Delivered live online through virtual classroom

View our training calendar to register for this course

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Introduction to Upstream Processing

Level: Introductory
Delivery: Online and in person 

Overview

This course includes both hands-on practical and theory components covering cell vial thaw, aseptic techniques, cell counting, metabolic analysis, scale up, and bioreactor operation. Equipment such as biosafety cabinets, cell culture consumables, wave bag reactors, stirred-tank reactors, as well as single-use bioreactors will all be utilized to reflect the current state of biopharmaceutical manufacturing technology.

Audience

Operators, technical staff, engineers, and managers wishing to increase their knowledge of the upstream operations in industrial biomanufacturing.

Key Topics

• Aseptic techniques in biological safety cabinets
• Mammalian cell culture best practices
• Analysis of cell growth and nutrients in culture
• Introduction to bioreactor operations (glass and disposable)
• Aseptically set-up and operate a 200L single-use bioreactor
• Aseptic connections and transfer to single-use bioreactors

Learning Objectives

• Understand the principles of aseptic techniques
• Describe the practice of culturing mammalian cells in an aseptic environment in small scale
• Count cells using both an automated and manual method
• Interpret the nutrient and metabolite levels of cell culture medium
• List the equipment required for scale up mammalian cultures
• Describe the cell expansion and inoculation methods in single-use systems
• Identify the main components of state-of-the-art bioreactor systems
• Aseptically prepare and run a 200L single-use bioreactor

Delivery

2 mornings of theoretical instructor-led online training in virtual classroom + 2 days in-person, hands-on training practical at a CASTL biomanufacturing training facility.

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Introduction to Downstream Processing

Level: Introductory
Delivery: Online and in person 

Overview
This course includes both hands-on practical and theory components covering topics including clarification, ultrafiltration/diafiltration, viral clearance, and chromatography. Participants will be introduced to the basics of filtration and chromatography in a theory session before building on this knowledge and performing these operations using a practical component.

Audience 

Individuals who are new to downstream processing including operators, technical staff, engineers, and managers who need to increase their basic knowledge of actual operations in a modern downstream processing biopharmaceutical plant.

Key Topics 

• Depth Filtration
• Sterile Filtration
• Tangential Flow Filtration (Ultrafiltration, Diafiltration & Microfiltration)
• Chromatography & Column Packing

Learning Objectives

• Describe the different types of chromatography operations used in a bioprocessing facility
• Pack chromatography column utilizing a flow pack method
• Describe the key operations of ultrafiltration diafiltration
• Perform protein concentration and buffer exchange using UF/DF systems
• Assessment 

Delivery

1 morning of theoretical instructor-led online training in virtual classroom + 2 days in-person, hands-on training practical at a CASTL biomanufacturing training facility.

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Biopharmaceutical Manufacturing Onboarding Boot Camp

Fast track your employee onboarding process with the Biopharmaceutical Manufacturing Onboarding Boot Camp. This course includes both hands-on practical training and theoretical knowledge covering good manufacturing practices (GMP), good documentation practices (GDP) including awareness of deviation and investigation, gowning, aseptic techniques, and how to operate the common equipment for all jobs in a manufacturing environment. Learners will gain the general knowledge needed to succeed in a career in biopharma manufacturing.

Who should take this course?

• Newly hired operators and technical staff as a part of onboarding in a modern biopharmaceutical or bioprocessing facility. 
• Any individual working in a supporting role to manufacturing could benefit from this training, for example, QA auditors.

Delivery

• Onsite at a CASTL Biomanufacturing Training Facility
• One day in-class theoretical
• Three and a half days practical

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Introduction to Fill and Finish

Level: Introductory
Delivery: In person

Overview
This course offers an introductory overview to current aseptic techniques related to working in an aseptic filling environment. It provides both an introduction to contamination control, environmental monitoring, filter integrity testing and filling systems, and hands-on interaction with RABs units while conducting glove integrity tests, media fills and troubleshooting.

Audience

Individuals who work or will work in Fill & Finish or those looking to learn and enhance their knowledge about operations in a modern biomanufacturing plant. The hands-on training will demonstrate the filling process and discuss engineering or quality aspects that are relevant to operators, engineers, or quality specialists.

Key Topics

• Aseptic definition, scope and process simulations (media fills)
• Good aseptic technique
• Basic microbiology, environmental monitoring, and control systems
• Filtration and liquid filter integrity testing
• Glove integrity testing
• Reading and evaluating media fills
• Good documentation practices
• Sterility testing and final product testing
• Use of barrier technology
• Environmental data trending and excursion analysis
• Manual visual inspection
• Facility design, velocity and airflow studies

Learning Objectives

• Demonstrate an increased proficiency of techniques and skills relating to aspect processing in filling activities
• Evaluate environmental monitoring programs to collect appropriate data, identify and interpret trends
• Describe the importance of filter integrity testing when filtering water, gasses or proteinaceous solutions
• Develop robust media fill protocols including appropriate interventions, observation and documentation procedures
• Discuss finished product testing requirements
• Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
   

Delivery
2 days

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Introduction to Single-use Technologies

Single-use technology is widely used within the biopharmaceutical industry and has quickly become a mainstay within the sector.

Introduction to Single-use Technologies is designed to complement CASTL’s in-person Introduction to Bioprocessing course and will highlight the technologies that can be implemented in upstream and downstream processing. Trainees gain hands on experience of common disposable technologies used in bioprocessing operations including bioreactors, connects/disconnects, tube welders and sealers, and disposable chromatography columns. Trainees will be exposed to strategies in implementing single use components, the regulation, and risk management around leachable and extractable studies.

Who should take this course?
This course is designed for those that are new to the use of single use technologies, including development scientists, process engineers, and manufacturing operators.

Delivery
Onsite at a CASTL Biomanufacturing Training Facility. 

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Good Manufacturing Practices (GMP) Workshop

Level: Introductory
Delivery: In person 

Overview

This course provides an overview of Good Manufacturing Practices (GMP), including the principles and standards essential for ensuring quality, safety, and efficacy in industrial (bio)pharmaceutical processes. It offers a comprehensive approach to understanding and applying GMP, with particular emphasis on the implementation and monitoring of quality systems, the rigor of documentation, and the importance of investigation management. It is delivered through a combination of theoretical presentations, interactive exercises, and case studies.

Audience

Individuals aspiring to enter the biopharmaceutical/pharmaceutical industry in entry-level positions, as well as for those already in the industry who wish to deepen their knowledge of the principles of good manufacturing practices.

Key Topics

• Principles of GMP, including quality and safety standards that govern the manufacture of high-quality products, ensuring traceability and compliance throughout the production process
• Quality management systems to control manufacturing processes, manage risks and ensure continuous improvement
• Good documentation practices to ensure accurate and compliant documentation to guarantee product traceability and conformity
• Investigation processes, including the identification of a deviation or problem, root cause analysis, implementation of corrective/ preventive actions, and documentation to ensure compliance and avoid the recurrence of incidents

Learning Objectives

• Understand the key components of cGMP, including why they are so critical
• Identify the key building blocks of a pharmaceutical quality system, including its scope and roles and responsibilities of different departments/functions
• Understand the importance of following 
   

Delivery

1 day

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Core Lab Skills

Level: Introductory
Delivery: In person 

Overview

This course introduces participants to fundamental lab skills required in a cGMP and/or GLP settings. Using a mixture of hands-on practical components at the training facility interspersed with equipment demonstration by the training team, participants will be introduced to general lab instruments and processes such as balances and balance verification checks, good weighing practices, pH and conductivity calibrations, measuring solution pH and conductivity, and preparing solutions at a benchtop scale. It also includes an introduction to pipetting (serological and micropipettes) and use of volumetric measurements in general lab function (use of graduated cylinders).

Audience

Individuals who aspire to enter the bioscience industry at entry-level positions and for those already in the industry who want to gain practical experience with common lab instrumentation and improve their overall understanding of industry best practices.

Key Topics

• Weighing operations using benchtop scale balances and including application of Good Documentation Principles (GDP), best practices when using balances and performing calibration verification checks, and solution preparation process at the benchtop scale
• Using pH and conductivity multimeters, including use of pH standard buffers to perform a 2-point standard calibration check, calculating the percent slope of calibration, and measuring the pH and conductivity of solution samples
• Volumetric measurement of process solutions as well as understanding graduations and menisci in the context of accurate measuring and dispensing 
• Pipetting practices for accurate and consistent pipette solutions using both serological pipettes and micropipettes

Learning Objectives

• Recognize the importance of calibration activities for routine operations in GMP (balances, pH, and conductivity multimeters)
• Identify and follow best practices when weighing lab reagents and when measuring and dispensing solutions for use in laboratories 
• Demonstrate proper use of micropipettes and serological pipettes for accurate and consistent solution dispensing tasks
• Understand the use of multimeters (pH and conductivity), the process for measuring the pH and conductivity of process solutions or samples, and proper handling and use of pH and conductivity probes 
• Understand the process for hydrating a lab reagent and preparing a small volume solution using benchtop equipment

Delivery

1 day

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Contamination Control

Level: Introductory
Delivery: In person 

Overview

This course is an introduction to the essential methods and practices for preventing, controlling, and managing contamination in an industrial production environment, in compliance with Good Manufacturing Practice (GMP). While emphasizing the importance of traceability and documentation to maintain rigorous quality standards, it addresses key issues such as hygiene, production area management, aseptic techniques and cleanroom behavior as well as methods for cleaning and disinfecting cleanrooms and equipment, the protective equipment required according to the grade of the area, and environmental monitoring. This course includes a combination of theoretical and practical training.

Audience

Individuals aspiring to enter the biopharmaceutical or pharmaceutical industry in entry-level positions, as well as for those already in the industry who wish to deepen their knowledge of contamination control in industrial production.

Key Topics

• Contamination risk assessment (microbial, chemical and physical) in the manufacturing process
• Contamination control strategies, including management of sensitive areas, rigorous hygiene, aseptic techniques, validated cleaning and disinfection techniques.
• Grade-specific dressing to reduce the risk of cross-contamination (i.e., dressing and using appropriate protective clothing according to the requirements of different grades of production areas (e.g. high and low contamination zones) 
• Control production environments (i.e., applying environmental control practices—air quality, temperature, humidity, viable and non-viable particle counts—to maintain an optimal manufacturing environment

Learning Objectives

• Understand the fundamental principles of contamination in industrial environments
• Become familiar with contamination prevention and control strategies
• Apply dressing rules according to the grade of production areas
• Understand how to apply rigorous environmental control

Delivery

1 day

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Aseptic Transfer Best Practices: Ensuring Sterility in Biomanufacturing 

Level: Introductory
Delivery: In person 

Overview

Aseptic Transfer Best Practices: Ensuring Sterility in Biomanufacturing" is an intensive workshop designed to equip biomanufacturing professionals with essential skills for maintaining sterility during material transfers. The course covers the fundamentals of aseptic techniques, cleanroom protocols, and step-by-step aseptic transfer procedures. Participants will also learn about handling and sterilizing equipment, troubleshooting contamination issues, and ensuring regulatory compliance. Through a mix of theoretical knowledge and hands-on practice, attendees will be better prepared to uphold sterility standards in biomanufacturing processes. 

Audience

This course is ideal for biomanufacturing technicians, operators, and process engineers responsible for aseptic transfers. Quality control and assurance personnel, production supervisors, managers, and regulatory affairs specialists will benefit from understanding aseptic transfer protocols to ensure compliance and process integrity. Additionally, training coordinators and R&D scientists involved in biomanufacturing will gain valuable insights into maintaining sterility. 

Key Topics

Theoretical concepts and background: 

• Overview of Cleanroom classification and contamination control  
• Aseptic processing and Biopharma Regulations 

Hands-on practical sessions: 

• Contamination control: EM, plates, hand hygiene, equipment sanitization and cleanroom sanitization 
• Aseptic Transfer Practical 
• Tube Welding 

Learning Objectives

• Understand importance of strategies for effective contamination control in cleanroom environments 
• Gain knowledge of regulatory requirements and standards governing aseptic processing in the biopharmaceutical industry 
• Conduct practical exercises in environmental monitoring (EM), using culture plates, and proper hand hygiene. 
• Master equipment and cleanroom sanitization techniques to maintain a sterile environment. 
• Perform hands-on practical sessions to execute aseptic transfers with minimal contamination risk. 
• Apply best practices and standard operating procedures for aseptic transfers in biomanufacturing. 
• Identify potential contamination sources and develop troubleshooting skills to address issues promptly. 
• Enhance problem-solving abilities in maintaining aseptic conditions during biomanufacturing processes. 

Delivery

2 days

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