Conserve Resources, Optimize Product Quality and Support for Successful IND Filings
IBC's Early Development Forums are a popular meeting place for research, development and regulatory scientists working in support of early stage process and analytical development.
The 7th conference in this series, Preclinical Scale Bioprocessing, provides you with the strategies you need to navigate this critical stage of bioprocess development in order to conserve resources, optimize product quality and support a successful IND filing.
Program designed to help your entire organization:
- Members of a cross-functional team working on process and analytical development who wishes to improve interactions among these departments
- Scientists or managers working for the first time on a bioprocess development project who need input, strategies and benchmarking
- Scientists or managers working on platformed development projects who are looking for ways to accelerate these projects and save resources
- Managers and executives looking to improve the prospects for outlicensing or selling a development program
- Contract organizations exploring opportunities to improve support for its clients early development projects
Highlights from this Year's Program
- Genzyme presents a case study of the successful integration in an early development program of functions including Process Development, Analytics, Preclinical Biology, Clinical Supply Manufacturing, Regulatory Affairs and Clinical Research
- ImmunoGen updates you on recent developments in identifying characterization methods and control steps for aggregation and subvisible particles, and how these impact early process and analytical development
- Biogen Idec shares a comparative analysis of three molecules developed using a platformed process and impacts on process consistency, product stability and meeting development milestones.
- Centocor demonstrates in-process product quality analyses of monoclonal antibodies and how it helped determine critical quality attributes (CQA) early in cell line development and identified molecular characteristics sensitive to process changes
- Allergan presents a comprehensive overview of the analytical methods used to support process development, formulation and stability programs for early protein drug development
- Genentech explores the challenges of achieving high upstream productivity while meeting downstream product quality goals
- Biogen Idec presents data on improvements to clarification and purification steps for highly productive cell-culture processes using exisitng facility infrastructure