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

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Scaling Up & Down with Optimized Bioreactors & Disposables 

Day 1 | Day 2 | Download Brochure | Short Courses 

THURSDAY, AUGUST 23

8:00 am Morning Coffee

 

DISPOSABLES 

8:25 Chairperson’s Remarks

Aurore Lahille, Ph.D., Specialist, New Technologies and Manufacturing Support, Merck Serono

8:30 A Single-Use Purification Process for the Production of a Monoclonal Antibody Produced in a PER.C6 Human Cell Line

Blanca Lain, Ph.D., Senior Scientist, Downstream Process Development, Percivia LLC - Biography 

9:00 Disposable Bioreactors: Adaption of Process Sensors and New Applications

Sascha BeutelSascha Beutel, Ph.D., Scientific Advisor and Substitute Director, Institute for Technical Chemistry, Leibniz University of Hannover - Biography 

Disposable bioreactors become more and more established in modern biotechnological industries. The major drawback is currently the adaption and integration of process analytical technology, especially online-sensors to monitor cultivation processes in time. In our current research we adapted various sensor elements to rocking-motion disposable bioreactors, as T-, pH-, DO-probes and others. We also investigated the usability of these reactor-systems for the cultivation of strict anaerobic bacteria, microalgae and fungi, comparability to conventional stainless steel fermenters and the possibility of up-scaling for chosen processes.

9:30 Use of Disposable Optical Sensor Patches (pH, DO, pCO2, Temperature and Conductivity) for Cell Culture, Purification and Media Preparation Applications

Janani RavindharJanani Ravindhar, M.S., Engineer I, Manufacturing Sciences, Biogen Idec

Currently, there are no means to take internal measurements in bioprocess bags during manufacturing operations. This has been identified as an area of increasing need for both upstream and downstream processing because of the increasing use of disposable bags, and the benefits of monitoring both physical and chemical parameters in real time. The use of optical sensor patches integrated to the bags offers to be a promising solution due to its capacity to provide continuous online data and enable future process control improvements. Additionally, the use of these sensor patches can aid with trouble shooting, proactively identify issues before proceeding to subsequent processing steps and ultimately save batches.

10:00 Coffee Break

 

SCALING UP 

10:30 Scale-Up Methodology for Viral Vaccines Processes

Ludovic-PeetersLudovic Peeters, Scientist, Cell Culture & Viral Process Development, GSK Vaccines

This case study will focus on the current GSK Vaccines approach to perform the scaling-up of cell based viral vaccines. Practical examples will cover adherent and non-adherent cell substrates and describe the specificity of stainless steel and single-use bioreactor technologies. The specificity of vaccine process constraints will also be covered.

 

11:00 Rapid Design and Manufacturing of Novel Engineered Protein Therapeutics

Trevor J. Hallam, Ph.D., CSO, Sutro Biopharma

Sutro has developed a scalable cell-free protein synthesis platform for the efficient production of therapeutic proteins. The process is separable into two phases, the production of a ribosome-rich cell extract and the subsequent production of therapeutic product. Once selection of the desired protein variant is made, scale-up to >100g scale can occur within days using the same process used at research scale with no reformatting required. Sutro plans to move to continuous extract production with subsequent disposable technologies capable of making hundreds of grams of API in 10-12 hours. The platform enables production of protein sufficient for GLP tox and clinical studies within a few weeks from first synthesis of DNA sequence.

11:30 Importance of End of Run Studies for a Scale-Up of Commercial Cell Culture Processes

Sofie GoetschalckxSofie Goetschalckx, M.S., Manufacturing Cell Culture Science Lead, Technology, Genzyme Belgium - Biography 

We have learned a great deal from end of run studies for improving cell culture performance and bioreactor design. In order to investigate the homogeneity of the culture and to improve the bioreactor configuration, End of Run (EOR) studies were performed at the end of the harvest phase. These analyses included stratification studies, cone dip-tube positioning, sparger performance and mixing studies.

12:00 pm End of Conference



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Download Conference & Course Catalog

CHI Catalog March 2018 - August 2018 Cover