Welcome
to CASTL’s
Online Academy
Your gateway to on-demand interactive biopharmaceutical manufacturing training
The CASTL Online Academy is the exclusive Canadian provider of award winning NIBRT courses. Our online academy provides easy to access, interactive and cost-effective online learning options on all aspects of biopharmaceutical manufacturing.
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With the CASTL Online
Academy, staying on top of your
game has never been easier
Making the CASTL Online Academy part of your workforce training strategy is a smart move to ensure access to an ever-evolving and up-to-date training library that allows you to maintain a skilled workforce and promote a culture of adaptability and innovation within your organization.
By training with CASTL, your team receives world-class biopharmaceutical manufacturing training that helps you maintain the highest quality assurance standards, be more efficient, and save on costs while being in full compliance with regulatory requirements.
The CASTL Online Academy delivers courses developed and offered by NIBRT, an award-winning bioprocessing research and training delivery organization based in Ireland.
The content in the online academy is interactive, cost-effective, and easily accessed by learners through the online learning portal. Online learning modules cover all aspects of biopharmaceutical manufacturing.
Why choose the CASTL Online Academy?
Discover the power of biopharmaceutical manufacturing through the CASTL Online Academy - a dynamic and effective platform tailored to companies, employees, and enthusiasts seeking comprehensive training in this thriving industry.
The CASTL Online Academy aims to empower individuals at every stage of their career, from recent graduates to entry and mid-level management, providing them with the knowledge and skills needed to excel in the world of biopharmaceutical manufacturing.
Available courses
Biopharmaceuticals: Overview of the industry
This course is designed to provide learners with a foundational understanding of the biopharmaceutical industry, which will take learners on a journey detailing where biologics come from right through to how they are manufactured. The course serves as a basis for learners to build their knowledge before taking more advanced NOA courses. A highlight of the course will be self-guided 360 tours of NIBRT's training plant which replicates a biologic manufacturing site. While on the 360 tours, learners will engage with interactive elements to gain understanding of the biopharmaceutical manufacturing process.
Lab Skills: Essential Lab Skills for Biopharma
This course is designed to provide learners with the basic practical laboratory knowledge and skills related to lab safety, volume measurement, and mass measurement. The course will equip learners with best practices concerning mass measurements using scientific balances and volume measurements using micropipettes. These types of measurements are key day-to-day lab activities and are essential to producing high quality data. Finally, learners will be guided through some of the everyday safety practices while working in a lab.
SUT: The application of Single-Use Technologies in Biopharmaceutical Manufacturing
The use of Single Use Technologies (SUT) in biopharmaceutical manufacturing has revolutionized the industry by providing flexibility, reducing cross-contamination, and decreasing capital and operating costs. This online course is designed to provide a comprehensive understanding of the application of SUT in biopharmaceutical manufacturing. The biopharmaceutical manufacturing process broadly consists of distinct "Upstream" and "Downstream" processing areas. Upstream processing involves the cultivation and growth of cells to produce the desired product, while downstream processing involves the isolation, purification, and formulation of the product for final use. In this course the harvest stage will be included in the upstream section. Fill/Finish is out of scope for this course.
Introduction to Quality Control Testing
This course provides a high-level general overview of the role of quality control testing and its importance in biopharmaceutical production. Quality control testing is a GMP requirement for any type of pharmaceutical production. This course provides the context for this testing in a biopharmaceutical production process, describing the complexity of biopharmaceuticals, potential process sampling points for testing and some of the key regulatory documents concerning quality control testing.
Trends in Biopharmaceutical Manufacture
Biopharmaceutical manufacturing has grown and matured and is no longer a novel area within the larger pharmaceutical landscape. However, it is still an area that is undergoing evolution and the manufacturing methods of yesterday and today, may not be the same tomorrow. This course will look at the current state of biopharmaceutical manufacturing and examine some of the drivers of change. It will also look at how methods and technologies, both in facility and equipment design, are facilitating manufacturing advances.
Introduction to Vaccine Manufacturing
This course focuses on vaccine manufacturing in the context of various viral and bacterial vaccine production processes used in biopharma today. It aims to help you build a broad understanding of the complex and varied nature of vaccine manufacturing processes, while exploring specific details for particular vaccine types.
Overview of Biopharmaceutical Manufacturing
This course provides an explanation of the principles of biopharmaceutical manufacturing by focusing on the processes typically involved in producing therapeutic proteins. The stages of manufacture from upstream, through downstream, to formulation and fill finish are shown, with explanations of the equipment and processes involved. Key concepts of good manufacturing practice (GMP), environmental control, and cleaning are covered.
Cell Biology and Recombinant DNA Technology
This course provides a description of cell biology and recombinant DNA technology as it is applied to the biopharmaceutical industry. The course describes the fundamentals of genetic engineering and how that technique can be used to make therapeutic products.
Biotechnology and Biopharmaceuticals
This course provides an introduction to biopharmaceuticals and their product characteristics. An explanation of the science of biotechnology that underlies biopharmaceuticals is provided. The content includes the role of DNA and proteins in the body, along with an explanation of Recombinant DNA and Monoclonal Antibody Technologies. The characteristics of biopharmaceutical products are explored and compared to traditional small molecule pharmaceuticals, with the main classes of biopharmaceutical products also being described.
Bioreactor Operations
This course provides a description of the operation of a mammalian cell culture bioreactor in the biopharmaceutical industry. The course describes critical parameters and the methods by which they are controlled. This course also deals with various modes of bioreactor operation and the advantages and disadvantages of each.
Upstream Processing: Bioreactors in Bioprocessing
This course provides a description of the use of bioreactors for cell culture in biopharmaceutical manufacture. Topics covered includes bioreactor design, construction, operation and control as well as cleaning and sterilization.
Fermentation in Biopharmaceutical Manufacturing
This course provides a description of the application of microbial fermentation in the biopharmaceutical industry. The course describes the importance of controlling the environment during manufacturing operations in order to promote cell growth and protein production.
Cell Culture in Biopharmaceutical Manufacturing
This course provides a description of the application of mammalian cell culture in the biopharmaceutical industry. The course describes the importance of controlling the cell culture environment during manufacturing operations.
Downstream Processing: Ultrafiltration and Diafiltration
This course provides a description of the application of ultrafiltration and diafiltration in downstream processing. The course describes the process considerations of this filtration technique within a protein purification context.
Downstream Processing: Protein Purification - Chromatography
This course provides a description of the application of the commonly used chromatographic methods in downstream protein purification including size exclusion, ion exchange, hydrophobic interaction and affinity chromatographies. The basics of a chromatography set-up are covered along with critical factors affecting protein separation such as column packing, resolution, column capacity, pressure and the chromatography matrix.
Downstream Processing: Centrifugation
This course provides a description of centrifugation technology and how it is utilised in the primary clarification phase of biopharmaceutical purification. The focus is on the function and operation of a disk-stack centrifuge, which is commonly employed in industry.
Cleanrooms and Cleanroom Behaviour
There are many possible sources of contamination in a cleanroom and in this course we will start off by defining what a cleanroom is and you will look at the different classes of cleanrooms. You will also explore the contamination entry routes. In addition, you will analyze the do's and don'ts when working in a cleanroom with a focus on how personnel can reduce their contamination impact.
Freeze Drying
This course provides a description of the processes associated with freeze-drying (lyophilisation) of biopharmaceutical products. The course describes the theory behind key concepts associated with temperature control, drying, equipment operation and their impact on product stability.
Formulation in the Biopharmaceutical Industry
This course provides an overview of the principles and practices of formulation and packaging processes in a modern biopharmaceutical manufacturing facility.
Clean In Place
This course provides an overview of the key concepts of Clean In Place (CIP) technology commonly used in the biopharmaceutical industry. It describes in detail the procedures and steps involved in CIP and provides examples of best practices that help ensure reproducible performance of a CIP cycle.
Aseptic Processing: Gowning
This course describes the requirements for gowning in various cleanroom classifications that are associated with biopharmaceutical manufacturing. This course also describes the procedures recommended for specific activities such as handwashing and donning of sterile gloves.
Aseptic Processing: Decontamination and Sterilization Technologies
This course defines the terms decontamination and sterilization and provides a description of some typical methods that can be used to decontaminate and sterilize process equipment and products in a biopharmaceutical manufacturing setting. The methods described include hydrogen peroxide vapour, moist-heat, dry-heat, and filtration.
Aseptic Processing: Contamination Control
This course describes the concept of contamination control within a biopharmaceutical manufacturing process. The course describes the importance of identifying and controlling routes of contamination entry in order to achieve sterile drug product manufacture.
Aseptic Processing: Concepts and Controls
This course provides an introduction to aseptic processing and its importance in biopharmaceutical manufacturing. The course describes how the risk of microbial contamination can be reduced by using suitable controls and procedures that minimise bioburden in the manufacturing environment such as cleanrooms, gowning, appropriate behaviour of personnel and environmental monitoring.
Aseptic Processing: Cleanrooms and Control Technologies
This course describes the concept of cleanroom design and operation from a contamination control point-of-view including contamination entry-routes, HVAC and HEPA filters, operation of airlocks as well as cleanroom architecture including design and maintenance.
Assessment and Certification for Fundamentals of Effective Risk Management
We recommend that you engage fully with each module and the embedded resources before attempting this assessment, but it is not required. You can complete any of the module, in any sequence or none at all, before attempting this assessment. You will receive a certificate of completion at the end of this module.
Module 1: The Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture
After completing this module - you will understand what is meant by biopharmaceutical product risk, be able to explain the importance of examining risk through the lens of the patient, be able to identify and classify different types of product risk, be able to identify the key stakeholders and explain why the patient comes first, embrace the importance of a proactive risk culture and make a personal commitment to always prioritize patient safety.
Module 2: Fundamentals of Risk Management
In this module you will build your awareness of the science and tools of risk management and understand the potential impact of your behaviours on the reduction of risk for your patients and your organization.
Module 3: Regulatory Requirements for Quality Risk Management in the Biopharmaceutical Industry
The main focus of this module is to familiarize you with the key regulatory requirements, industry guidance and international standards associated with Risk Management and to make the connection to the underpinning current cGMPs. Armed with this knowledge you should feel confident to contribute to QRM activities.
Module 4: Implementing Effective Risk Control Strategies
In this module you will have the opportunity to familiarize yourself with the typical risk controls in place for products and processes in a biopharmaceutical manufacturing setting.
Module 5: Application of Quality Risk Management Every Day
In this module you will review some examples of the everyday application of Risk Management. After completing this module, you will have have an opportunity to review worked examples of everyday QRM examples, participate in a Validation Risk Management Scenario, be able to select appropriate actions or tools for a range of given risk events, describe the importance of involving individuals with a diverse range of skills and perspectives and demonstrate the importance of maintaining vigilance and personal accountability.
Module 6: Your Role in Preventing and Reducing Product and Patient Risk
This module is designed to enable you to reflect on your learning across the course and to reinforce the importance of the role that you play everyday in preventing and reducing product and patient risk.
Process Validation 1: Process Design
This course provides an overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and Quality Risk Management (QRM).
Process Validation 2: Process Qualification and Control
This course provides an overview of the qualification and continuing verification stages of process validation. This course is intended to demonstrate how a biopharmaceutical process must be capable of reproducible commercial manufacturing and to provide ongoing assurance that the process remains in a state of control.
Advanced IEX Chromatography for Bioprocessing
In this course, you’ll get a detailed view of ion exchange (IEX) chromatography. This advanced course focuses on process development of IEX chromatography in bioprocessing. This course will help you identify the critical and key process parameters for optimization of IEX chromatography using high-throughput process development (HTPD) techniques.
Advanced MM Chromatography for Bioprocessing
In this course, you’ll get a detailed view of mixed mode, or multimodal (MM) chromatography. This advanced course focuses on process development of MM chromatography in bioprocessing. This course will help you identify the critical and key process parameters for optimization of MM chromatography using high-throughput process development (HTPD) techniques.
Biomanufacturing Process Capability Requirements
In this course, you will learn to identify process capabilities needs in order to produce the required quality and quantity of biotherapeutics—with patient safety and drug effectiveness in focus. The course describes the role of quality by design as per ICH guidelines in bioprocess development. You will learn about the different stages in biologics production and strategies used to prevent product and process related impurities.
Filtration Process Development
In this course, you will explore in detail the operating parameters, their optimization and other key considerations for design and scale-up of an effective filtration process. This course will guide you on maintenance issues and costs related to filtration as a unit operation.
Introduction to Preparative Protein Chromatography
In this course, you will learn about the principles of preparative chromatography for protein purification and how to perform it. You will familiarize yourself with different types of columns and stationary phases and learn more about different types of chromatographic techniques like affinity and size exclusion chromatography. You will explore chromatography performance factors including efficiency and resolution as well as throughput and productivity. This course also covers purification strategies and various modes of chromatographic operations and their practical applications. You will explore the methods used to scale up from a lab to production scale and relevant challenges.
Overview of Host Cells for Bioprocessing
In this course, you will learn about the prevalent host cell types and potential disruptors for biomanufacturing. After completing this introductory course, you will be able to select the right kind of host cell type for production of the protein of your interest.
Overview of the Biopharma Industry and Products
In this course, you will acquaint yourself with the current healthcare status and role of biopharma industry. This course states the dynamics of health around the globe and the various biotherapeutics available to treat both communicable and noncommunicable diseases. You will learn about different types of biotherapeutics used to fight disease, ranging from small molecules like insulin to large molecules like monoclonal antibodies. Some examples of blockbuster drugs are also shown.
Understanding Filtration in Bioprocessing
In this course, you will understand the principles of filtration. This course also shows how filtration works as a unit operation in the upstream and downstream stages of bioprocessing. You will explore normal and cross flow filtration in detail by familiarizing yourself with the mechanisms of action, classification of filters, process set-up, process parameters, maintenance, and applications for the different filtration modes. This course also delves into the key properties of filters, the factors affecting filters and filtration performance, and how to choose the right kind of filter for your intended applications.
Understanding Upstream Bioprocessing
In this course, you will learn the fundamentals of upstream bioprocessing. This course provides an understanding of the underlying principles of good process design required to succeed in upstream biomanufacturing. In this course you’ll familiarize yourself with the concept of kinetic modeling, discover the key steps in process modeling, and learn the mass balance variables to optimize your bioreactor appropriately.
Introduction to Gene Therapy
This course provides an overview of the key concepts of gene therapy. It defines the term as well as exploring the differing concepts of gene therapy and gene editing and how they may be achieved. The course also describes the various modification methods such as viral vector or nuclease delivery. The course also looks at the current methods for scaling up the manufacture of these therapies and some ways in which this may be optimised in the future.
Introduction to Cell Therapy
This course provides an overview of the key concepts of cell therapy. It defines the term as well as exploring the major cell therapy modalities. It also looks at the current state of manufacturing of these therapies and looks forward to how this may change in the future in order to meet the demands of a changing market.
Viral Vector Production for Gene Therapy - Full Learning Plan
Viral vectors are fundamental to gene therapy and gene modified cell therapies which are the frontier of modern medicine.
This is a learning plan that offers the introduction to viral vector production for gene therapy and the presentations on the upstream process, downstream purification, filling and quality control processes.
Viral Vector Production for Gene Therapy - Upstream
This presentation on the Upstream Process is part of our series of online courses on viral vector production for gene therapy. It contains: A presentation on XDR systems- Fermenters and Bioreactors for scale up of suspension cell culture- By Yasser Kehail (Cytiva); A presentation on iCELLis Bioreactors- Virus Production from Bench to Industrial Scale- By Dr. Dana Pentia (Pall); A practical demonstration: Single Use Rocker Bioreactor Set-Up; A practical demonstration: Single Use Stirred Tank Bioreactor Set-Up; A practical demonstration: Microcarriers.
Viral Vector Production for Gene Therapy - Quality Control
This presentation on the Quality Control process is part of our series of online courses on viral vector production for gene therapy. It contains: A presentation of analytics for viral vectors - Dr. Åsa Hagner McWhirter (Cytiva); A practical demonstration: SDS-PAGE; A practical demonstration: ELISA; A practical demonstration: HPLC.
Viral Vector Production for Gene Therapy - Introduction
This introduction presentation in a series of online courses on viral vector production for gene therapy. It contains: An Introduction to Gene Therapy and Current Market Landscape by Dr. Adam Pritchard (NIBRT); A practical demonstration: Cell Culture Start-up; A practical demonstration: Suspension Cell Culture; A practical demonstration: Adherent Cell Culture.
Viral Vector Production for Gene Therapy - Downstream Purification & Filling
This presentation on the purification and filling process is part of our series of online courses on viral vector production for gene therapy. It contains: A presentation on downstream purification of viral vectors - Dr. Dana Pentia (Pall); A presentation on purification of viral vectors - Dr. Åsa Hagner McWhirter (Cytiva); A practical demonstration: Depth Filtration; A practical demonstration: Disposable Chromatography; A practical demonstration: Disposable Ultrafiltration/Diafiltration; A practical demonstration: Filling Overview.
ATMP Fluid & Cold Chain Management Webinar
During this webinar, you will gain insights into scalable single-use technologies, advantages of automated sterile filling processes for small volumes, and controlled freezing applications down to -80°C or -196°C. You will also learn about shortfalls in current manufacturing processes and how they can cause unnecessary product loss, product quality reduction or other efficiency downfalls. This webinar will provide case studies and an overview of available solutions on the market that can be used to overcome challenges faced in the industry.
Reliable Data Driving Business Resilience
This short webinar discusses how Data Reliability can enhance long term business resilience. ERA Sciences recognises 4 key data reliability pillars: Data Integrity, Risk Management, Stakeholder Engagement, Application Lifecycle Management. Together these pillars enable reliable data and will be briefly discussed. ERA Sciences will then talk about why it may be time to evaluate existing Application Lifecycle Management (ALM) to ensure that GxP data is working for you and where it’s possible to eliminate non-value add activities.
The Quantum Leap to GxP 4.0: Labs of the Future
The recorded webinar "The Quantum Leap to GxP 4.0" is designed to provide you with answers to some of these most troubling issues. We present to you some 4.0 solutions that may be familiar to you or completely new, but our aim is unchanging; to make the 4.0 Quantum Leap less daunting! The GxP facilities, both pharma and biopharma, are experiencing a huge trend towards adoption of Industry 4.0 technologies, to optimize our complex, time-consuming, and data-heavy production processes. But, in the GxP world, there are often hurdles we must overcome when introducing new technologies, due to the heavily regulated nature of our industry.
The Quantum Leap to GxP 4.0: E-Validation & Tech Transfer
The recorded webinar "The Quantum Leap to GxP 4.0" is designed to provide you with answers to some of these most troubling issues. We present to you some 4.0 solutions that may be familiar to you or completely new, but our aim is unchanging; to make the 4.0 Quantum Leap less daunting! The GxP facilities, both pharma and biopharma, are experiencing a huge trend towards adoption of Industry 4.0 technologies, to optimize our complex, time-consuming, and data-heavy production processes. But, in the GxP world, there are often hurdles we must overcome when introducing new technologies, due to the heavily regulated nature of our industry.
The Quantum Leap to GxP 4.0
The recorded webinar "The Quantum Leap to GxP 4.0" is designed to provide you with answers to some of these most troubling issues. We present to you some 4.0 solutions that may be familiar to you or completely new, but our aim is unchanging; to make the 4.0 Quantum Leap less daunting! The GxP facilities, both pharma and biopharma, are experiencing a huge trend towards adoption of Industry 4.0 technologies, to optimize our complex, time-consuming, and data-heavy production processes. But, in the GxP world, there are often hurdles we must overcome when introducing new technologies, due to the heavily regulated nature of our industry.
Introduction to Gene Therapy Manufacturing
This webinar focuses on the rapidly developing landscape, interest and recent approvals in Gene Therapy. As recombinant adeno-associated viruses (rAAV’s) are widely used as the viral vector system to deliver therapeutic genes to cells the webinar will particularly focus on this delivery system. Key to the use of rAAVs is an efficient production and purification system that will produce viral vector in sufficient quantity and of requisite quality for clinical applications. This webinar provides an introduction to the current methods employed in the manufacturing of rAAV’s to address the growing demand for this class of therapy.
Bioreactor Operations
This course provides a description of the operation of a mammalian cell culture bioreactor in the biopharmaceutical industry. The course describes critical parameters and the methods by which they are controlled. This course also deals with various modes of bioreactor operation and the advantages and disadvantages of each.
Inoculum and Cell Culture Virtual Reality Beta Version
This immersive virtual reality simulation replicates the process of conducting an aseptic cell vial thaw using a biological safety cabinet (BSC) within a cleanroom environment. The trainee will perform a virtual garbing procedure, where the appropriate protective equipment is put on, before setting up the BSC for the operation. The vial thaw process will then be conducted within this rendered cleanroom setting. Step-by-step instructions are provided to guide the trainees through the processes in a highly detailed virtual environment.
Introduction to Cell Therapy Manufacturing
The recorded webinar provides an overview of the general concepts of cell therapy including gene-modified cell therapies, such as CAR-T. The topics covered will firstly provide a definition of cell therapy, gene-modified cell therapy, and ex-vivo gene therapy as there is a lot of cross-over in these areas. In addition, the webinar discusses some of the major therapeutic areas such as CAR-T and stem cells in terms of mechanism of action and manufacturing methods.
Glycan Characterisation
The recorded webinar "Glycan Characterisation" presents invaluable information on your biologics that world leading NIBRT Contract Research provides.
Good Handwashing Technique
This handwashing demonstration video outlines the importance of good handwashing technique in the prevention of the spread of microorganisms. The video includes a demonstration of a thorough handwashing technique using blue paint as a substitute for soap, to demonstrate the maximum soap coverage desired when washing hands.
Vaccine and Immunity
This short e-lesson describes the important role that vaccines play in global health, in the fight against infectious diseases. Topics covered include the basics of what pathogens are and how they cause disease, how our immune systems react to infections and how the use of vaccines can aid help boost immunity. An introductory insight into the different types of vaccines and an overview of production methods will also be provided.
Introduction to Viruses
This course introduces what viruses are, their basic structure, how they can infect cells and also looks at the way they can be transmitted from person to person and what measures can be taken to control the spread of viruses. Key topics covered include: basic definition of a virus, the abundance of viruses in nature, virus binding, modes of virus transmission, control of virus transmission.
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