Developing for Scalability
How to adequately explore the process development design space to ensure future scalability. Implementation of new technologies to model and analyze bioprocess operations before and during scale-up are also discussed.
- Ben Beneski, Senior Manager, Amgen

Improving Delivery of a New Automated Bioprocess Systems to Your Facility
How to realize the maximum benefit from automated bioprocessing, focusing on best practice and lessons learned from successful implementation.
- Shaun J. McWeeney, Process Engineer, Centocor

Leveraging Disposables for Bioprocess Manufacturing
This session will survey the single-use technology commonly employed in bioprocess manufacturing and provide key points to consider for the design of bioprocessing equipment & facilities that utilize disposables.
- David Marks, President & Senior Consultant,, DME Alliance Inc.

21 CFR Part 11 - Practical Implementation of Electronic Records in a Regulated Bioprocessing Facility
This session will review practical application of the 2003 guidance document to bioprocessing systems. Real-world examples and analogies to illustrate the compliance requirements and implementation of electronic records and signatures technology will be presented.
- Shaun J. McWeeney, Process Engineer, Centocor

ASTM E2500-07 - The New Paradigm for Verification of Bioprocess Systems
This session will provide guidance on the requirements and concepts put forth by E 2500-07, the new ASTM Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. We will cover such concepts as Product/Process User Requirements, Project Quality Plans, Construction Quality Plans, Risk Assessments, Verification Testing and Plans and how to maximize the benefits of these activities.
- Jason Tansky, Staff Engineer, Centocor

Plant De-Bottlenecking
This session will address the question of how best to configure a process operation to maximize the manufacturing capacity. Analysis and modeling techniques will be discussed for the identification and prevention of significant bottlenecks when either a new product is introduced into a facility or the capacity needs to increase.
- Kenneth Hamilton, Director, Engineering, Genentech

Points to Consider for the Execution of Technology-Intensive Projects
The proper introduction and integration of technology is a key component for the success of projects in biologics manufacturing facilities. This session will present best practices and practical rules of thumb for the execution of capital projects involving bioprocess technology.
- Sean Illig, Deputy Director, Process Engineering, Sanofi Pasteur

Building a Technology Transfer Process
This presentation will focus on strategies for efficient technology transfer from process development to manufacturing.
- Frank Abbato, Principal Engineer, DME Alliance, Inc

Conceptual Design for Biopharmaceutical Facilities.
Discussion will focus on the methodology required to evaluate the feasibility of projects involving new or renovated bioprocess systems, and create a conceptual design that addresses user requirements. Workshop exercises will apply the methods and techniques associated with the conceptual design of a typical biologics process in a new facility.
- Sean Illig, Deputy Director, Process Engineering, Sanofi Pasteur

Managing Small Projects and Renovations in a GMP Bioprocess Manufacturing Environment
This session will develop a practical approach to the execution of time and resource-limited projects within a regulated bioprocessing facility.
- Charles A. Crosier, Project Engineer, Diosynth Biotechnology