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

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

This online course focuses on the development of gene therapeutics with emphasis on viral delivery, GMP and process and facility design as well as manufacture and commercialisation of gene therapies. Themes include the use of viruses and vectors and their production, bioreactors and biomanufacture and regulation of gene therapies.

This course enables the learner to:

·       Identify diseases where gene therapy may be applicable

·       Understand key elements of virology in creating gene therapies

·       Understand the importance of vector biology in gene therapies

·       Understand the principles of good manufacturing practice

·       Fundamentals of upstream and downstream processing

·       Recognise regulatory and ethical issues relating to gene therapy

·       Identify and recognise challenges in gene therapies

This hands-on course teaches laboratory scientists and engineers how to handle and maintain mammalian cells applying appropriate aseptic techniques as well as how to evaluate cell quality using a range of analytical assays.

It provides a practical understanding of how to recover, cultivate, and preserve mammalian cells applying aseptic techniques at conventional laboratory scale. Training is focused on the hands-on application of industry relevant Standard Operating Procedures (SOPs) which are enhanced by relevant virtual reality simulations.

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.

This module focuses on product purification and, through a series of lectures and case studies will enable you to:

• Understand the principles of different methods of process chromatography, including Packed Bed, Monoliths, Expanded Bed.
• Select the appropriate media for, and predict the performance of, chromatography separations upon scale-up.
• Assess the suitability of affinity separation as a product purification operation and gain awareness of advances in rational ligand design for difficult separations.
• Determine appropriate strategies for the maintenance of column and process hygiene.
• Consider how chromatography is changing at industrial scale, and which new technologies will have an impact in the future.

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

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

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

This course is designed to provide delegates with a practical understanding of the set-up, inoculation and operation of lab and small pilot scale, single-use bioreactors for the culture of different types of mammalian cell used for biotherapeutic and vaccine production.

The course will provide delegates opportunities to sub-culture adherent HEK cells and suspension CHO cells from shake flask sub-culture through to laboratory scale bioreactors including a single-use, stirred bioreactor system (10L scale) and an iCellis® Fixed-Bed Bioreactor.

Delegates will get hands-on experience with mammalian cell sub-culture prior to familiarisation with standard operating procedures (SOPs) for typical mammalian bioprocesses. Delegates will also be provided with hands-on training in aseptic technique, seed train preparation and maintenance, and bioreactor seeding, sampling, and operation. Delegates will also be given key insight into operational methods/alternatives and general design considerations for mammalian bioprocesses.

In addition, delegates will learn industrially relevant analytical techniques including cell counting, viability and metabolite analysis.

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 is designed to explore the critical issues at each stage of vaccine development. Attendees hear from international experts about the research as well as operational and regulatory challenges facing the global vaccine market. In addition to expert lectures and excellent networking opportunities with your peers, one case study will be conducted during the workshop about strategies for commercial specifications for vaccines.

Topics covered will include:

Introduction to Vaccine Development with Case Studies

Scale-up from lab to pilot scale

Quality by Design (QbD) as part of vaccine development

Expression systems

Single use platforms

Process Development Challenges of Novel Vaccines

Adventitious Agent Contamination in Biomanufacturing

Final formulation and adjuvants

Regulatory Perspectives and Future Directions

Global Vaccine Preparedness to Respond to Future Disease Outbreaks

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. In addition, support the user to navigate which MVDA or MI algorithm should be implemented to better understand the cause-and-effect relationship within their data and how to apply these tools to generate predictions of key process parameters.

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.

This module shows laboratory scientists and engineers how experimental design techniques can be used to rapidly understand and optimise bioprocess performance.

It provides managers with insights on how experimental design and small scale experimental models can underpin Quality by Design (QbD) approaches. Training is focused on the hands on use of DoE software rather than underlying statistics. Bioprocess case studies, supported by a series of introductory and expert lectures will enable you to:

• Generate appropriate experimental designs within fixed research budgets and timescales.
  • Ensure analytical methods can be validated and provide reliable data for process evaluation.
  • Rapidly screen and optimise different fermentation media and operating conditions.
  • Obtain the highest yield of active product throughout your downstream process sequence.
  • Understand the relationship between DoE and QbD
  • 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.