• The foundation stone of QbD is process understanding
• Many observations made in early development are neglected until later on in development
• This represents a missed opportunity

• Biopharmaceutical and drug product manufacturing considerations when optimizing drug substance properties
• Use of modelling tools and institutional knowledge to assist the process 
• How to efficiently manage the QBD paradigm through the development cycle

• Biopharmaceutical and drug product manufacturing considerations when optimizing drug substance properties
• Use of modelling tools and institutional knowledge to assist the process 
• How to efficiently manage the QBD paradigm through the development cycle

• Application of composite process analytical technology (PAT) array for monitoring crystallisation processes
• Presentation of the Crystallisation Process Informatics System (CryPRINS) as an intelligent decision support and control system for crystallisation product design
• Direct design and rapid scale-up of crystallisation processes using concentration feedback control and automated direct nucleation control (ADNC)
• Application of ADNC for the control of size, shape, polymorphic form and purity of pharmaceutical products
• Controlling crystal shape distribution using growth modifiers
• Monitoring and control of continuous crystallisation systems

• Connecting the dots from the factory floor to the patient outcomes
• Presenting statistical software solutions to achieve effectively QbD in development
• Numerous examples on processes, analytical procedures and bioassays
• Effective implementation of Q8 applied from small molecules to vaccines

• Where ‘research’ meets ‘development’. Selecting and designing quality & functional attributes in lead candidates (pre-process QbD?)
• Early assessment of developability & safety to reduce attrition and costs
• In silico tools to predict and tune down developability & immunogenicity issues
• Early (surrogate) parameters for risk assessment.  When the devil is not in the detail

• In the era of QbD, systematic and data-driven approaches to bio-therapeutics are needed more than ever
• Such approaches are resource-intensive, costly and contradict the need for being lean and fast, particularly in early development
• Is it possible to satisfy the “need for speed” in early development without compromising the systematic approach needed for building quality into processes and products?

• Vaccine process : DoE,  an attractive tool to overcome the process development challenges from upstream to formulation and filling steps
• DoE application : a perpetual compromise between methodology, information expected, scale down model, capacity and timelines
• Case study : implementation of scale down model combined with DoE for process modelisation and improvement of vaccine manufacturing process at industrial scale

• How do we ensure full traceability of starting materials for viral vectors?
• What are the risks associated with the starting material for GMP manufacture of viral vectors?
• How can the hazards be mitigated?
• Possible issues due to the novelty of such IMPs and disease targets
• Our experience to date

Panellists will share strategies to move therapeutic entities from creation to development and commercialisation.  How can scientific evidence and molecular pharmacology best link with manufacturing process parameters and clinical activity relationships?  Improving real-time monitoring, specifications and product analysis for APIs,excipients, biologics and ATMPs to maximise patient benefit will all be considered.

Panellists will share strategies to move therapeutic entities from creation to development and commercialisation.  How can scientific evidence and molecular pharmacology best link with manufacturing process parameters and clinical activity relationships?  Improving real-time monitoring, specifications and product analysis for APIs,excipients, biologics and ATMPs to maximise patient benefit will all be considered.

Panellists will share strategies to move therapeutic entities from creation to development and commercialisation.  How can scientific evidence and molecular pharmacology best link with manufacturing process parameters and clinical activity relationships?  Improving real-time monitoring, specifications and product analysis for APIs,excipients, biologics and ATMPs to maximise patient benefit will all be considered.

Panellists will share strategies to move therapeutic entities from creation to development and commercialisation.  How can scientific evidence and molecular pharmacology best link with manufacturing process parameters and clinical activity relationships?  Improving real-time monitoring, specifications and product analysis for APIs,excipients, biologics and ATMPs to maximise patient benefit will all be considered.

• Brief overview of Today´s Market Requirements for Primary Packaging Systems
• New generation elastomeric materials for parenteral applications
• The implementation of QbD principles in Primary Packaging
• Benefits using QbD for Primary Packaging Systems

• Decisional tools work carried out in the EPSRC Centre for Innovative Manufacturing in emergent macromolecular therapies             
• Tools enabling greater process understanding through modelling and optimisation and hence help achieve QbD
• Demonstration of tools with case studies on the optimisation of purification sequence, equipment sizing and operating parameters of biopharmaceutical manufacturing processes

• Lyophilization: the process benefits & challenges
• Application of DoE in formulation development
• Model studies of DoE in formulation development
• Considerations for DoE in freeze drying cycle optimisation

• Managing the high dimensional data available from PAT
• Maximising the information extracted from data
• Risk-based decision making from available knowledge
• Understanding the benefits of the approaches

• Understanding the link between process variables and product quality attributes
• Demonstration of the effect of process changes on both in-process intermediates and final product quality
• Utilising historical manufacturing data to establish acceptable ranges for process variables
• Conducting process validation batches on legacy products, using in-process and final product monitoring

• Defining  the product profile
• Understanding the design space?
• Building a design space as applied to blending

• Using data in early-phase manufacturing for QbD
• Benefits for a fuller QbD programme
• Decreasing QbD timelines by effective use of early phase data

• Identifying limitations in mammalian cell expression systems
• Novel approaches to the early selection and identification of high producing cell lines
• Cell engineering approaches to enhance mammalian cell phenotypes
• Translation engineering and reduced temperature cultivation