The Programme

Designing an effective biotech manufacturing facility

• What steps are involved?
• Understanding the process of zonalisation
• How to design the optimum biotech facility
• Utilising sound engineering principles in the overall process

Manufacturing challenges in the production of cancer vaccines

• The challenges of live virus production
• Process scale-up through the development phases
• Viral characterisation and analytical issues during process change
• Maintaining quality standards in the manufacture of patient-specific vaccines

Review of key gene therapy and manufacturing approaches

• Understanding the new gene class of therapy
• Review of manufacture and product specifications
• Overcoming manufacturing difficulties

Development of a high throughput manufacturing process for an Ovine polyclonal Fab fragment

• The aspects of process design and development that facilitate the scale up of a manufacturing process by a factor of 15 fold
• Using scale down process models, DoE and outer limit studies
• Considering chromatography scale, solution utilisation, product recovery and waste management
• Increasing facility annual productivity

Lunch

Streamlining technology transfer for biologics - avoiding pitfalls

• The need for careful upstream preparation by product owners prior to technology transfer
• Optimal partnering and technology transfer
• Critical factors and practical methods to ensure efficient technology transfer from client to CMO

Orthogonal virus clearance concepts for state of the art bio manufacturing

Building an efficient and easy to validate platform of technologies to remove viruses on biotechnological processes

• Nanofiltration
• AEX membrane chromatography
• UVC inactivation

Virginie Brochier
Manager of Chromatography Services Laboratory
PALL BIOSEPRA

Mixed-mode chromatography: a new tool for process development

• MEP HyperCel and capturing and purification of monoclonal and polyclonal antibodies
• Impurity removal in a biopharmaceutical environment
• Optimization and scale-up of the capture of β-lactoglobulin from micro-filtrated bovine
• Optimising chromatography conditions

Jo Dalle
Director, Manufacturing
GENZYME

Robert Shaw
Technical Director
ARK THERAPEUTICS

Colin Love
Development Director
BIOVEX

Richard Francis
Director, Process Development and Technical Support
PROTHERICS

Panel discussion - optimising facility utilisation to increase manufacturing capacity

• Low cost manufacturing – mission impossible?
• Reducing long lead-times, high cost and lack of predictability
• Implementation of process and operational excellence

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to an aspect of biomanufacturing.

Characterization of biotechnology pharmaceutical products

• Characterizing the safety identity, purity, consistency and potency of biotechnology-derived products
• Careful characterisation of the product to avoid unwanted effects
• The abilities and limitations of current analytical methodologies

GlycoOptimisation of antibodies and biopharmaceuticals

• Optimising the glycosylation pattern in order to achieve the desired glycosylations
• Stable transfection of glycosylation enzymes
• The analysis of the glycosylation machinery
• Production of glycoprotein in high amounts with optimal sialylation

Dietmar Weilguny
Principal Scientist
SYMPHOGEN

Production of recombinant polyclonal antibodies using Sympress technology

• One pot production of polyclonal antibodies
• Batch to batch consistency of recombinant polyclonal antibody production
• Characterization assays for analysis of recombinant polyclonal antibodies

Protein A affinity chromatography - historical development, novel media and new insights into mass transfer mechanism

• A review on old Protein A affinity media and the progress that has been made over the years
• Literature survey about the latest relevant publications with industrial development examples of antibody purification based on Protein A
• Recent comparisons of novel Protein A affinity media