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WEDNESDAY, APRIL 14
8:00am Morning Coffee
8:30 Chairperson’s Remarks
Dagmar Meissner, Owner & Founder, BioProcess Solutions
Featured Presentation & Case Study
8:35 Development, Scale-Up and Implementation of an Advanced Downstream Process for Recombinant Plasma Proteins
Jens H. Vogel, Ph.D., Global CMC Development Team Leader; Head, Isolation & Purification Department, Global Biological Development, Bayer Healthcare
This case study will cover the development and implementation of new platform technologies and processes for more efficient manufacturing of next-generation recombinant protein drugs at Bayer. The challenges during development,
scale-up and transfer will be highlighted, as well as the concepts and methodologies used to successfully overcome them. Data will be shown from small-scale through commercial scale, including a comparison with a conventional process.
9:05 Highly Efficient Production of Diverse Protein Targets From Cell Substrates Engineered with Lentiviral Vectors
Boro Dropulic, Ph.D., President & CEO, Lentigen Corporation
Lentiviral vectors are known as the most efficient method to deliver genes stably into cells. There are several significant advantages for using this technology for protein production: (i) Quality – multiple gram levels of protein production from mammalian cells while maintaining high levels of glycosylation; (ii) Flexibility – applicable to all mammalian cell types, including adherent or suspension cells; (iii) Speed – multiple gram quantities of fully glycosylated protein within 12 weeks of sequence availability; (iv) Robust productivity – high transgene copy number per cell mitigates risk of gene silencing; and (v) Economics – high level of production in supernatant significantly decreases upstream and downstream costs; this technology is well suited for integration with disposable bioreactor systems.
9:35 Manufacturing Process Changes for Biotech and Pharmaceutical Products
Suketu Desai, Ph.D., Vice President, Chemistry, Manufacturing, Controls & Quality, Ception Therapeutics, Inc.
Manufacturing changes are routinely required during manufacture of biotechnology and pharmaceutical products. An overview of study design to support scale up and process validation for manufacture of biotechnology drug substance and drug products will be presented.
9:55 Networking Coffee Break, Poster and Exhibit Viewing
10:40 Increasing Commercial Capacity via the Integration of Process and Facility Enhancements
Erik T. Fouts, Ph.D., Senior Director, Process Sciences, BioMarin Pharmaceutical, Inc.
Several approaches can be used to meet the demands of expanding markets for commercially licensed therapeutic proteins. Capacity can be increased by constructing new manufacturing areas, increasing the scale of operations, and/or introducing new cell lines or technologies that can provide greater productivity. Often, several options are simultaneously evaluated in the development of a strategy that addresses both the business risk and regulatory path. This presentation will review the options described above as they were assessed and applied to the lifecycle management of a commercially licensed recombinant therapeutic enzyme.
Featured Presentation
11:10 The Role of the Pilot Plant in Product Development
David Clark, Ph.D., Global Head of Pharma Pilot Plants, Centocor / J&J
The R&D pilot plant plays a critical role in scale-up and process development. This presentation will take a holistic view and illustrate how the pilot plant can be most effectively used to enhance product development, process technology development, technology transfer, and personnel development.
11:40 End of Process Change for Protein Scale-Up meeting