The Programme

Registration

Bill Thompson
Consultant
ROTHERWOOD ASSOCIATES

Opening remarks from the Chair

Start up and capacity planning in a new biotech facility

• Balancing up and down stream capacity to optimize utilization
• Methods for discovering potential bottle necks
• Avoiding bottle necks by design and production planning
• Optimize staffing levels by giving design input at an early stage of a project.

Improving downstream processing in the light of high titer

• new challenges in downstream process development
• Binding capacity and column geometry as bottlenecks
• Case studies for improved downstream processing

Building the cGMP manufacturing platform for "Actobiotics": live recombinant Lactococcus lactis for the targeted delivery of therapeutic proteins

• Introduction: the novelty and therapeutic potential of Actobiotics
• Biological containment and other regulatory aspects
• How to efficiently integrate several external CMO partners and technologies towards the design of an optimal process

Morning refreshments

The role of disposables in optimised bioprocesses

• Potential efficiency gains from disposables by replacing traditional equipment
• Removing cleaning and sterilisation steps to reduce time and energy consumption
• Reviewing current limitations in manufacturing scale and functionality
• Discussing additional costs of waste disposals

A fast and high yielding CHO cell line development platform

• Overview: Progress in cell line and process performance
• Results from expression technology evaluation studies
• Case studies of CHO cell line development platform

Lunch

Cell engineering for step change in bioprocess development and manufacture

• Impacts of upstream processing on whole bioprocess development
• the role of cell engineering on the selection and operation of downstream options
• Changes to E.coli to reduce contaminants

Biosimilar Development: a Pioneer's Perspective!

• Biosimilar landscape
• Biosimilar development concepts
• Design specification
• QbD cell line & process development
• Comparability
• Biosimilars: today’s reality

Defining the Design Space of an Upstream MAb process in early process development: Strategy Tools and Case Study

• Review Strategy and Tools and opportunities used to construct a design space
• Case study : Tools to identify and select CQA's through data assessment
• Identify & Establish links between CQA and realtime process variables
• DOE to verify links between CQA to process variable
• Process Modelling and diagnostics tools

Afternoon refreshments

Voraxaze a case study into the integration of small scale studies forced degradation and process validation programs

• Review of a process development program utilizing a combination of small scale studies and historical manufacturing data to define process parameters
• Incorporation of the output from a forced degradation study in relation to the process development and validation programs
• Integration of process and product characterization programs

Analytical methodologies for highly potent biologicals - an unusual case for process applications

• What are highly potent biologicals?
• Analytical methodologies for process and final product uses
• Issues surrounding analytical applications – safety and containment
• Is there a role for rapid methods?

Late phase process development by applying Quality by Design (QbD)

• Presenting recent achievements of titer increase in mAb production by media development supported by DOE
• Lessons learned from an mAb process transfer to large scale production
• USP-Development of a biosimilar – strategy and case studies

Closing remarks from the Chair and end of Day One

Registration

Opening remarks from the Chair

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 a current aspect of Biomanufacturing.

Lunch

“Mixed-mode” chromatography materials in downstream process development

• Optimisation of capture and intermediate process steps by using “mixed-mode” chromatography materials
• Specific binding of desired therapeutic proteins and efficient removal of major contaminants lead to high product purity (> 80%) after a single purification step
• Case studies with recombinant proteins from different expression systems
• Potential integration of “mixed-mode” materials in general purification platforms

Novel liquid-liquid scalable extraction/ chromatography technology

• Showing recent progress on the predictable scale up of two different kinds of liquid-liquid high resolution chromatography
• Explaining the principles of variants of counter current chromatography (CCC): dynamic extraction technology (hydrodynamic) and centrifugal partition chromatography (hydrostatic)
• Reviewing resent research progresses

Streamlining technology transfer for biologicals: from client to CMO and back

• Focusing on critical factors and practical methods to ensure efficient technology transfer from client to CMO and visa versa
• Highlighting possible obstacles created by either party technical and non-technical
• Discussing various solutions to remedy such situations

Afternoon refreshments

Balancing the need for speed during early stage clinical development versus late-stage commercial antibody processes

• Platform cell lines and processes to ensure speed-to-clinic
• Optimization of downstream operations to support high-titer bioreactor processes
• Impact of high titer bioreactor processes on plant capacity and cost of goods

Intensification of a PER.C6R-based recombinant Ad35 manufacturing process to prepare for commercial scale production

• 5-10 fold increase in bioreactor harvest titers
• Reduction in process and manufacturing cycle time
• Decrease in COG's

Closing remarks from the chair

Close of conference