This online course is designed to provide an intensive overview of the antibody therapeutics field, enabling you to:

• Gain a comprehensive understanding of the historical aspects, current research and future direction of the development of antibodies as therapeutics.

• Provide an overview on key aspects including antibody structure,function, diversity, antibody fragments and Antibody Drug Conjugates

(ADCs)

• Gain insights to some of the issues that are required to develop antibodies from the bench to the clinic/market and raises issues with regard to manufacture, intellectual property and regulatory aspects.
• Effectively engage in cross-disciplinary collaborations with other professionals on how to formulate a strategy to design, develop and apply industry regulations and best practice to ensure quality and success.

Flexible Learning

Self-paced learning through a series of interactive audio presentations and animated videos. From the date of enrolment, delegates can access online materials for up to 9 months allowing for flexible study.

Focusing on how to specify the process and how to determine its economic feasibility.

This module focuses on how to specify a complex bioprocess and determine its economic feasibility. It will:

• Specify a major item of process equipment.
• Interpret engineering drawings used in equipment procurement.
• Perform economic analyses of the process and determine sensitivities to process changes.
• Achieve value for money in complex engineering projects.
• Recommend a process that is technically feasible and economically viable.
• Determine the types of data needed to specify unit operations and processes.
• Develop process flowsheets and mass balances.
• Network with sector leaders and subject matter experts.

The cost of the course includes tuition, course materials, lunches, refreshments and a networking dinner. Accommodation is not included.

This module focuses on how to take a process from a paper design to fully-operational facility, and will enable you to:

• Design a plant layout considering the relevant regulatory requirements.
• Understand the impact of facility design requirements on costs.
• Determine a project schedule including phases, installation, commissioning and validation.
• Accurately interpret engineering drawings used in design.
• Prepare a safety and environmental review to define risks, hazards and safety strategy.
• Understand the role of contractors, work with them more effectively and analyse their proposals.
• Network with sector leaders and subject matter experts.

 The cost of the course includes tuition, course materials, lunches, refreshments and a networking dinner. Accommodation is not included.

This course addresses the real-world challenges of translating discoveries to the clinic in a way that is commercially viable. A series of lectures and interactive case studies will enable you to:

• Understand the distinctions of manufacturing cells compared with biologics
• Understand the challenges faced in advancing cell and gene therapies to clinic and the lessons learned from established companies
• Understand the impact of design and engineering considerations on cell and gene therapy manufacture
• Identify and define critical process parameters for different cell and gene therapy applications
• Knowledge and application of analytical toolsets for quality measurement
• Understand key implications to facilitate and expedite translation from laboratory to a manufacturing and clinical setting

This course provides delegates with an introduction to the basic principles of protein chromatography and the practical experience of operating an AKTA system.

During the course delegates will be able to understand the performance of the AKTA, write and run scripts on the AKTA and be able to run a chromatographic separation according to a standard operating procedure (SOP). They would be able to extract, analyse and interpret data from the AKTA as well as learning to optimise chromatography process parameters for a typical monoclonal antibody (mAb) separation.

Hands-on sessions will be supplemented with introductory lectures and trouble-shooting sessions. Industrial speakers will share their experience of Chromatography technologies and their industrial application.

Understand the principles of all the major recovery operations: Centrifugation, Membrane Systems, Filtration, Cell Disruption, Precipitation, Flocculation. This module focuses on the biological product recovery stage and, through a series of lectures and case studies will enable you to:

• Compare these unit operations for suitability within the process and study them in our unique pilot plant
• Determine the most appropriate equipment for separations and specify the right operating conditions
• Learn to use Ultra Scale Down tool for prediction of large scale separation performance
• Understand the interaction among fermentation, recovery and purification and learn the integrated solutions for bioprocess development

Get expert guidance on choosing on how best to integrate QbD, DoE and PAT into lifecycle approach to process characterisation.

A series of stimulating interactive lectures from experts in the field and teamwork activities will enable you to:

• Learn about the latest FDA and EMEA regulations with regards to QbD, PAT, process characterisation and validation.
  • Understand current and future perspectives of the impact of QbD and PAT on the effort required for process characterisation.
  • Learn how to perform Risk Assessments to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
  • See examples of how to combine scale-down models with historical knowledge and DoE to map out Design Space.
  • Understand the principles behind the characterisation and validation of unit operations, such as fermentation, filtration, chromatography, formulation through to supply chain logistics.
  • Learn how to apply QbD to continuous operations, e.g. perfusion culture and filtration operations.
  • Explore the impact of single-use components on validation needs
  • Apply QbD when implementing pre/post-approval process changes.
  • Network with sector leaders and subject matter experts.

The cost of the course includes tuition, course materials, lunches, refreshments and a networking dinner. Accommodation is not included.

The course will provide an introduction into the most important statistics and data exploration tools necessary to evaluate challenging bioprocess data sets.

 This course will provide the delegate with the following skillset:

• Practical data analytic tools in Python: Learn the basics of Python by analysing real-world data sets
• Multivariate data analysis (MVDA) and Machine learning (ML) expertise: Build and validate advanced process models on challenging bioprocessing data sets
• “Big Data” analytics: How to deal with large manufacturing data sets and automate the model building process
• Bioprocessing expertise and knowledge: Learn the most important statistics and data exploration tools necessary to interpret challenging biologic data sets

 The cost of the course includes tuition, course materials, lunches, refreshments and a networking dinner. Accommodation is not included.

This hands-on course is designed to provide delegates with a practical understanding and operation of lab-scale microbial bioreactors.

The course will provide delegates opportunities to sub-culture industrially relevant strains of microbes such as E. coli and P. pastoris at different scales spanning shake flasks, a single-use Ambr® 250 high-throughput platform and a reusable 5L UniVessel.

Delegates will become familiar with standard operating procedures (SOPs) for typical microbial bioprocesses before being given the opportunity to work together to set-up and run a fermenter. Delegates will also be provided with hands-on training in aseptic technique, flask seeding and maintenance, and bioreactor sampling.