Covering the spectrum for the biopharmaceutical industry
The following agendas are provided as top-level examples of courses we have delivered for clients in the past.
We have access to a global network of more than 100 industry experts with wide-ranging specialisms so if you do not see your chosen topic in this catalog, simply get in touch and we will be happy to develop the training for you.
Develop a deep understanding of bioprocessing to ensure quality and compliance.
Introduction to regulatory guidance: ICH, EMA, FDA
Quality by Design (QbD) concept and approaches
Risk assessment methodologies & practical considerations
Stages in process development
Small-scale process model utilization
Control strategy development and implementation
Process performance qualification
Continuous process verification and validation
Regulatory dossier considerations
Gain a clear overview of upstream process development for successful transfer to downstream processing on this 2-day course
Examine the principles of separation chemistry to develop a robust early downstream process operation for your biologic
Learn the various types of Tech Transfer that can occur during biopharmaceutical manufacturing and how to effectively plan for them
Introduction to Tech Transfer
Formal aspects of Tech Transfer
Tools for Tech Transfer
Managing scale-up and other risks in Tech Transfer
Dealing with complexity
Get to grips with the main challenges of stability testing for biological products
Understanding biologics and the differences to small molecules
Introduction to regulatory guidance: ICH, FDA, EMA, WHO
The basic principles and review of ICH guidance, with applicability to biologics
Target, accelerated, stress and forced degradation conditions
Additional stability studies and needs during development
Requirements for stability-indicating methods
Using stability during comparability
Interaction of GMP
Gain an understanding of regulatory and technical considerations to help you manage process change in the manufacture of biologics
How approaches to variations differ in the EU and FDA and how different changes will be handled in the different regions
Relevant guidelines
Analytical considerations – Demonstrating comparability based on physicochemical and biological studies
Regulatory expectations for two major changes: site transfer and scale-up
Designing a clinical comparability program
Biosimilar perspective
Applying modern concepts such as PAT and Design Space
The implications of getting it wrong
Learn to use Design of Experiments (DoE) methods to improve the efficiency of trials
DOE design types – Uses and limitations
Software tools for DOE
DOE and Bioanalytical development stages: Phase appropriate considerations
Experimental system suitability
Understanding reproducibility and sources of variation
Key points for optimization
Problem definition
Design set up and execution
Data analysis
Model verification/validation
Undertake a deep strategic analysis of biopharm CMC studies to increase efficiency and reduce costly non-compliance delays
Managing stage-specific specifications for biotech/biosimilar products
Biotech analytical methods: Specific Examples of method lifecycle studies
Development and validation of process-specific host cell protein (HCP) assays
Design and execution of analytical comparability studies for biotechnology and biosimilar products
Reference standards and materials for biotechnology and biosimilar products
Learn best practices for working in a cell and gene cleanroom to ensure compliance with aseptic GMP standards
Principles for personnel, material, samples, and waste flows in a cleanroom environment
Behavior in the cleanroom
Gowning
Basic microbiology, EM principles and contamination prevention
What is APS?
Operational basics for commonly used equipment: Viable and non-viable particle counting, hoods, pipettors, incubators, autoclave
Aseptic procedures in the hood
Learn the essential computational processes necessary to analyze bioassays and immunoassays
Discover strategies to develop a high-quality continuous bioprocess to improve manufacturing efficiency
Acquire a practical understanding of the regulatory challenges, manufacturing concerns, and clinical trial preparation for cell and gene therapies or ATMPs
Practical considerations for the Investigational Medicinal Product Dossier (IMPD)
Examine factors such as organism type, yield and environmental stress to help you select a bioreactor and maximize its performance