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 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.

https://www.ucl.ac.uk/biochemical-engineering/study/mbi-modular-training/mbi-courses/antibody-targeted-therapy

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.

Learn how experimental design techniques can be used to rapidly understand and optimise bioprocess performance.

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

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.

This module will strengthen your knowledge of fermentation processes and through a series of lectures and case studies will enable you to:

• Define different modes of fermentation and know their limitations.
• Develop a suitable medium and perform a material balance.
• Interpret fermentation data and use it effectively.
• Characterise the kinetics of cell growth and how they apply to different cell systems.
• Determine fermentation productivity and yields.
• Learn about new developments in fermentation technology (single use bioreactors)
• Develop a strategy for fermentation process 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.

This module focuses on the design and specification of bioreactors and the application of microscale techniques for rapid fermentation process development and scale-up. A series of comprehensive lectures and case studies will enable you to:

• Understand engineering principles of fermentation.
• Determine power consumption and oxygen mass transfer.
• Evaluate different strategies for scale-up and scale-down.
• Know about miniaturised bioreactors and their role in fermentation process development.
• Understand how to design a bioreactor and use data from microscale experiments for scaleup.

Learn how to make the best-fitting practical decisions to enable digital-readiness within bioprocess industries.

The training sessions will explore how simple and easy-to-adopt tools can provide substantial benefits in data analysis, and data-driven decisions made for process development and optimisation. This will be supported by a series of expert lectures on: 

• Systematic data acquisition and storage infrastructures
• Management of large data storage and handling platforms
• Pipelines for retrospective analysis of historical datasets for process development and optimisation
• Development of efficient process models enabled through high quality data availability
• Role of bioprocess automation and semantics in supporting automation-related decisions
• Role of metabolic models in bioprocess monitoring and control
• Out-of-the-box thinking in adopting the most suitable configuration to address the needs of specific bioprocesses
• Regulation of the use of AI in Biopharma and Biologics

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

Delivered in collaboration with Massachusetts Institute of Technology (MIT), this course will assist in developing your knowledge on the challenges of creating a vaccine process.

This three-day course will explore the critical issues at the various stages of vaccine development. International experts with over 10 years’ experience in their field will lead delegates in developing their understanding in the research, development, operational and regulatory challenges of the vaccine market. In addition to expert lectures and excellent networking opportunities with your peers, one case study will be conducted during the workshop about manufacturing at-risk with real examples from the influenza manufacturing process.

Topics covered will include:

• 
  Scale-up from lab to pilot scale
  • Quality by Design (QbD) as part of vaccine development
  • Expression systems
  • Single use platforms
  • Regulation and its impact on development
  • Final formulation and adjuvants
  • Developing world needs

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