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Scaling Up & Down With Optimized Bioreactors + Disposables - Day 2


Scaling Up & Down with Optimized Bioreactors + Disposables 


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Thursday, August 25

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

 

Optimizing Bioprocesses 

8:25 Chairperson's Remarks

Wayne Curtis, Ph.D., Professor, Chemical Engineering, Penn State University

8:30 Stability Studies to Support Comparability Studies

Nanda SubbaraoNanda K. Subbarao, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.

Stability testing is a cornerstone of comparability demonstration and Stability Studies are required as part of testing to show comparability of pre and post change lots. Current regulatory expectations for performing such stability studies will be discussed. Studies at the long term storage condition required to evaluate the whether the shelf life and impurities of the DS or DP pre and post change are acceptable. Stability studies under accelerated and stress conditions are very useful to provide a quick evaluation of the absence of differences in the fragility of the product before and after the change and to detect any new degradation pathways. Differences between comparability studies for products during clinical studies and post approval will be discussed.

9:00 DOE 101: The Basic Principles of Design of Experiments

Martin KaneMartin Kane, Associate Director, Process Statistics, Human Genome Sciences, Inc.

Design of Experiments (DOE's) are tests or series of tests in which purposeful changes are made to the input variables of a process or system so that we may observe, learn, and identify the reasons for changes in the output response(s).  This talk is an introduction to design of experiments with an emphasis on basic principles.  Benefits of DOE include cost savings, determination of the interdependency between variables, hidden replication, predictive capability, optimal setting of specifications and key quality characteristics.
 

9:30 Platform Development Strategy for the Production of Monoclonal Antibodies by Glycoengineered Yeast

Jeffrey MerckJeffrey Ly, Staff Biochemical Engineer, Biologics New & Enabling Technologies, Merck & Co., Inc.

An alternative to mammalian cell culture being investigated is the use of faster growing microbial systems which offer the ability to reduce development timelines and production costs. The use of glycoengineered Pichia pastoris libraries, that replicate the most essential glycosylation pathways found in mammals, is now becoming a viable option. Glycoengineering offers the unique advantage of producing more homogeneous glycosylation patterns, as opposed to the large heterogeneity of glycan moieties found in mammalian cells. Examples will be presented where antibody titers > 1g/L are expressed in large scale cultivations with uniform human N-linked glycans. Optimization of process conditions through statistical design of experiments, molecular profiling and metabolite analysis enabled the development of a commercially viable & robust platform process that yields consistent productivity and product quality.

10:00 Networking Coffee Break

 

Innovating Bioreactor Use & Design 

10:30 Advances in Simulation Methods for Predicting Mass Transfer in Gas-Sparged Bioreactors

Chris AntoniouChris Antoniou, Principal Project Engineer, Global Engineering & Technology, Biogen Idec

This talk will review computational fluid dynamics (CFD) simulation methods for designing and optimizing bioreactors. In particular, two different approaches (Lagrangian particle tracking and Eulerian population balance) for modeling gas sparging are discussed. These approaches are applied to a commercial mammalian cell culture bioreactor. Different sparger configurations are analyzed to understand effect of geometrical changes. The talk summarizes results of the two approaches and provides guidelines for simulations.
 

11:00 An Automated, Sensorized Scalable Bioreactor for 3D Perfusion Cell Seeding and Culture, Within Multiple Independent Chambers

Stefania Adele Riboldi, Ph.D., Co-Founder and CEO, SKE Advanced Therapies 

Bioreactors, as a means to generate and maintain a controlled culture environment and enable directed tissue growth could represent the key element for the development of automated, standardized, traceable, and safe manufacturing processes for engineered tissues for clinical applications. To this purpose, an automated, scalable device capable of online, real-time monitoring of critical culture parameters will be presented, representing a step forward towards a reliable, safe and automated manufacturing of biological tissues.

11:30 Plastic Bioreactors: Smart & Cheap, Not Disposable

Wayne CurtisWayne Curtis, Ph.D., Professor, Chemical Engineering, Penn State University

We developed and patented a simple plastic bioreactor for the purpose of enabling lower-value bioproducts production (not the alternative paradigm of convenience and disposability). Cost reduction is also achieved by avoiding instrumentation in favor of smart, feed-forward control. We have demonstrated these to 100-L scale with plant tissue culture performance comparable to traditional cell culture reactors. Ongoing work includes development for cellulosic biomass, autotrophic fermentations plant propagation and microbial waste-to-value bioprocesses.
 

12:00 pm End of The Bioprocessing Summit



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