October 14, 2020 10am EST / 16:00 CET

Status as of 30/09/20LBC@levitronix.com www.levitronix.com/LBC2020

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Oakwood has an aseptic process for manufacturing polymer-based biodegradable microspheres for the sustained

release of pharmaceuticals. Levitronix pumps and flow meters are utilized in various aspects of our continuous

manufacturing process. An overview of Oakwood’s microsphere manufacturing process will be presented with

several examples of different sustained release formulations. The impact of switching from traditional peristaltic

pumps to Levitronix pumps will be discussed.

Samantha Cramer works as a Formulations Engineer at Oakwood Labs, with more than 10 years of experience in industry. Samantha started her role at Oakwood Labs in 2016 working to develop and scale-up controlled release microsphere based formulations. Throughout her career she has encapsulated small molecules and various peptides. She also spent 3 years at the Cleveland Clinic Lerner Research Institute. Samantha holds a Master’s Degree from Cleveland State University and a Bachelor of Science from Purdue University.

Oakwood Labs

Formulations Engineer III

Samantha Cramer Using Levitronix pumps in various unit operations of the microsphere manufacturing process

SPEAKERS

SPEAKERS

Single-use (SU) components are increasingly used for the production of biologics, and many production steps

have successfully shifted from stainless steel to SU components. In the cell harvest, however, current technologies

struggle to keep up with the increasing demand for larger batch volumes and higher cell densities. Depth filters,

for instance, require too many modules and have a huge footprint, in addition to being susceptible to turbidity

breakthrough.

The CONTIBAC® SU filtration technology of DrM excels where other technologies crumble, due to introducing two

novel concepts in the field:

Cake (dead-end) filtration: The filter medium does not perform the filtration, but it acts as a support for the

filter cake consisting of cells and filter aid. As a result, the filtration is much faster, and the filter medium can be

regenerated by back-flushing from the opposite side.

Cyclic operation: Since the filter medium can be regenerated, the filter can be operated in a cyclic fashion as

will be explained in the webinar.

In the webinar it is demonstrated that the aforementioned filtration concepts allow for achieving unprecedented

filtration rates without sacrificing filtrate quality. It will be discussed what percentage of impurities such as host

cell proteins or DNA can be removed during the filtration, and how the flow rates and impurity removal can be

altered using pH adjustments.

Tizian Bucher has been leading the research and development department at Dr. Müller AG for 1.5 years. His key responsibilities are to develop new products in the field of filtration and mixing based on theoretical, experimental and numerical studies. Moreover, he strives to close the gap between fundamental research and product development.

He earned a B.S., M.S., and Ph.D. degree in mechanical engineering from Columbia University in New York. The focus of his M.S. was in mechanics and system identification & control, while the focus of his Ph.D. was in laser manufacturing. He also participated in several research projects that were at the intersection between biomedical and mechanical engineering.

Dr. Mueller AG

R&D Engineer

Dr. Tizian Bucher Cell Harvest using Cyclical Cake Filtration

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SPEAKERS

Oncolytic virotherapy has been recognized as a promising new therapy for cancer for decades but only few viruses

have been approved worldwide. The therapeutic potential of oncolytic viruses can be severely restricted by innate

and adaptive immune barriers making oncolytic virus clinically inefficient.

To overcome this obstacle, we utilized human adipose-derived stem cells (AD-MSC) loaded with tumor selective

CAL1 oncolytic vaccinia virus to generate a new therapeutic agent called SNV1 (SuperNova-1). SNV1 cell-based

platform protects and potentiates oncolytic vaccinia virus by circumventing humoral innate and adaptive immune

barriers, resulting in enhanced oncolytic virotherapy.

Thomas Herrmann works as Director, Translational R&D and Manufacturing at StemVac GmbH. He has more than 10 years of experience in process development of manufacturing and purification processes for vaccinia virus. He also developed up- and downstream processes for infected human adipose derived stem cells which will be used as Trojan horses for vaccinia virus to treat cancer. Under his supervision final processes were transferred to contract manufacturer for GMP production. He worked more than 6 years as a research and senior scientist at Genelux GmbH where he was responsible for the production of new recombinant vaccinia viruses which were used in an inter- company project in molecular PET diagnostics of tumors financed by the BMBF.

After receiving his PhD in Biochemistry at the University of Wuerzburg, he worked as a research scientist at the Department of Clinical Neurobiology at the University Clinics of Wuerzburg for 5 years. During this time he studied changes in axon growth of motor neurons in transgenic animal models for spinal muscular atrophy.

StemVac GmbH, Director

Translational R&D and

Manufacturing

Thomas Herrmann Trojan horses fighting cancer: The next level in oncolytic virus therapy