APR 6, 2022

Bioprocessing 2022

Over the last three years, Labroots has brought Bioprocessing to the forefront of the scientific virtual event community by showcasing transformations and advancements in the field. Labroots is excited to announce its 4th Annual Bioprocessing Virtual Event to highlight new advances in development, methodology, and manufacturing.

Join us for this free, one-day event, on April 6, 2022, as we focus on breakthroughs in upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing.

This year’s event includes the following topics and tracks:

Preclinical Development
This track walks you through new methods of detection and characterization of novel biologics and biotherapeutics.

Characterization of Novel Biotherapeutics
Detection and Characterization of Impurities in Biologics
Rapid Methods to Access Quality and Stability of Biologics

Upstream Processing
Everything from early-stage cell isolation/cultivation to banking and culture expansion, this track covers methods of optimization in addition to modeling and manufacturing.

Cell Culture Optimization and Cell Line Development
Microbial Processes Development and Optimization
Cell-free manufacturing (or Unconventional Expression Systems to cover novel hosts)
Perfusion vs. Batch Operation for Cell Culture
Modeling and Simulation

Downstream Processing
Cell disruption, purification, and polishing. Everything you need to know about recent advances in downstream processing can be found in this track.

Continuous Processing
Advances in Purification Unit Operations
Advances in Nonchromatographic Purifications

Analytical & Quality
Quality control and analysis are essential to improving standards and output.

Online Process Monitoring
Real-time QA/QC for Rapid Release
PAT Implementation for Process Control

Cell, Gene and Nucleic Therapies (Novel Modalities)
Different types of manufacturing and analytics require their own coverage, this track focuses on novel methods in cell, gene, nucleic acid, and vaccine manufacturing & analytics.

Cell Therapy Manufacturing/Analytics
Gene Therapy Manufacturing/Analytics
Nucleic Acid Manufacturing/Analytics
Vaccine Manufacturing/Analytics
Regulations and Standards

Manufacturing
New methods in modeling, manufacturing, and production.

Digital Biomanufacturing and Industry 4.0 Concepts
Process Characterization, Modeling & Control
Agile and Mobile Manufacturing
Cell Free Synthesis
Integrated/Continuous Production

Call for Posters — Work in bioprocessing at any level? Preclinical, upstream, downstream, analytical, Quality Control, or post-production manufacturing? Share your work! Presenting a virtual poster with Labroots has many benefits, not only in that you can do it from the comfort of your own home or office. When you present a poster at a Labroots virtual event you are putting it directly in front of other specialists in Bioprocessing all over the world.

Virtual poster sessions offer the opportunity to present data to a global audience via a PDF poster (with optional audio/visual element) and discuss your results with interested colleagues through email. Plan now to have your poster included in the 2022 Bioprocessing Virtual Event. Submission is free. Submit your abstract and poster here.

Miss the event? It will remain open for 2 years from the date of the live event with webinars and posters available for unlimited on-demand viewing. This virtual conference also offers increased reach for the global bioprocessing community with a high degree of interaction through live-streaming video and chat sessions.

Continuing Education
Labroots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this event, you can earn 1 Continuing Education credit per presentation for a maximum of 35 credits.

Connect with us and other members of the Bioprocessing community!

When you attend the event remember to use the hashtag #LRbioprocessing to follow the conversation and connect with other members of the global Bioprocessing community! Follow bioprocessing-related pages @CellBiology_LR on Twitter and @CellandMolecularBiology.LR on Facebook to connect with our specialist Cell Biology Sciences Writers and stay up to date with the latest Trending News in Cell Biology!

Use #LRbioprocessing to follow the conversation!

Speakers

Samir Acharya, PhD

Associate Director, Process Development, Andelyn Biosciences
BIOGRAPHY
Dr. Mark Dürkop

CEO Novasign GmbH, Project Lead BOKU - Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna
BIOGRAPHY
Alois Jungbauer, PhD

Professor, Department of Biotechnology, University of Natural Resources and Life Sciences, Institute of Bioprocess Science and Engineering
BIOGRAPHY
Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology
BIOGRAPHY
Kevin G. McGarry, Jr., PhD

Manager, Analytical Development, Andelyn Biosciences
BIOGRAPHY
Prof. Dr.-Ing. Habil. Ralf Pörtner

Hamburg University of Technology, Institute of Bioprocess and Biosystems Engineering
BIOGRAPHY
Leonardo Rios Solis, PhD

Lecturer (Asst. Prof) in Synthetic Biology and Biochemical Engineering, Centre for Synthetic and Systems Biology, Institute for Bioengineering, The University of Edinburgh
BIOGRAPHY
Sami Ullah, PhD

Scientist - Tumor Biology, Department for Human and Animal Cell Lines, Leibniz Institute DSMZ (German Collection of microorganisms and cell cultures)
BIOGRAPHY
Christian Witz, Ph.D.

Head of the Computational Bioprocess Engineering Group at the Institute for Process and Particle Engineering, Graz University of Technology
BIOGRAPHY
Andrew L. Zydney, PhD

Bayard D. Kunkle Chair and Professor of Chemical Engineering, Director, Membrane Science, Engineering and Technology (MAST) Center, The Pennsylvania State University
BIOGRAPHY

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Agenda

Download Agenda

APR 06, 2022 9:00 AM PDT

Keynote Presentation: Continuous Bioprocessing - New Challenges and Opportunities for Membrane Technology

Andrew L. Zydney, PhD

Bayard D. Kunkle Chair and Professor of Chemical Engineering, Director, Membrane Science, Engineering and Technology (MAST) Center, The Pennsylvania State University
BIOGRAPHY

There is growing interest in the development of integrated continuous bioprocesses for the production of important biotherapeutics due to the potential for enhanced productivity, greater flexibility, and improved product quality. The transition from batch to continuous bioprocessing requires a major re-thinking of the downstream purification process, creating exciting new opportunities for membrane technology. This talk will focus on the use of continuous countercurrent staged membrane systems for initial product capture and for final formulation. Continuous Countercurrent Tangential Chromatography (CCTC) provides truly continuous steady-state product capture and purification using a column-free system in which the chromatographic operations are conducted on a flowing slurry using hollow fiber membranes to control the resin flow. Results using a Protein A affinity resin show high levels of host cell protein removal from a monoclonal antibody product, with the countercurrent staged providing significantly greater throughput with improved product yield and purification. A similar approach can be used for continuous selective precipitation of monoclonal antibodies, completely eliminating the high cost of the affinity resin. Countercurrent staged diafiltration has been developed as a new strategy for providing high levels of buffer exchange in a single-pass continuous format. These examples highlight how one can adapt membrane systems to continuous bioprocessing, providing exciting opportunities for improved manufacturing of high-value biopharmaceuticals.

Learning Objectives:

1. Explain the benefits of implementing continuous bioprocessing.

2. Identify the opportunities for using countercurrent staging to enhance the performance of downstream processes.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
APR 06, 2022 10:30 AM PDT

Panel Presentation: An Overview of Gene Therapy Manufacturing: Development through Commercial Production

Kevin G. McGarry, Jr., PhD, Samir Acharya, PhD

The field of gene therapy is young and rapidly evolving, with new information discovered every day and an ever-increasing number of novel therapies entering various phases of clinical trials. For over 15 years, Nationwide Children’s Hospital in Columbus, Ohio, has performed as a research leader in the gene therapy field, and Andelyn Biosciences was born of this expertise in 2020. As gene therapy continues to grow, scientists must continue to learn from the rich, albeit recent, history and consider new insights from early developmental research through commercial production of a gene therapy product. There are high-level points and potential challenges to consider, including early development and selection of a viral vector, vector design, strategies for upstream and downstream process and platform development, in-process characterization of a product, and scalability, among others. This overview will cover these topics through the process of bringing a new product to the clinic.

Learning Objectives:

1. Explain what is gene therapy is.

2. Explain what steps are involved for getting a gene therapy product to the clinic.

3. Discuss development and manufacturing processes, analytics, and potential challenges.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE

Kevin G. McGarry, Jr., PhD
Manager, Analytical Development, Andelyn Biosciences
BIOGRAPHY

Samir Acharya, PhD
Associate Director, Process Development, Andelyn Biosciences
BIOGRAPHY
APR 06, 2022 11:30 AM PDT

Keynote Presentation: A Generic Manufacturing Platform for Downstream Processing on Non-mab Proteins

Alois Jungbauer, PhD

Professor, Department of Biotechnology, University of Natural Resources and Life Sciences, Institute of Bioprocess Science and Engineering
BIOGRAPHY

The vast structural diversity of proteins is responsible for their functional versatility, but also makes their expression and purification a demanding task. Tagging proteins with affinity tags can overcome the complexity of conventional purification by enabling affinity chromatography. An overview will be given for the purification of tagged proteins and then a purification system using a circular permutated caspase will be described in detail. It has been developed for process fusion protein processing to generate an authentic N-terminus for all 20 amino acids. The system employs widely available affinity chromatography resins, and a simple process can be used regardless of the specific nature of the protein of interest.

Learning Objectives:

1. Explain the processing of fusion proteins and non-mAb proteins.

2. Discuss the generation of an authentic N-terminus.

3. Discuss the effect of enzyme kinetics on process of fusion proteins.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
From Experiments, Data, Hybrid Models, and Digital Twins. Several Up- and Downstream Success Stories Highlighting the Benefits of Using Advanced Process Modeling

Dr. Mark Dürkop

CEO Novasign GmbH, Project Lead BOKU - Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna
BIOGRAPHY

The application of modeling tools to better understand and control bioprocess development and manufacturing has become a hot topic within the last few years. However, what do we actually need? Is it just about data and powerful modeling algorithms, or is there more to consider to accurately describe a process and transfer the knowledge and model structure from early-stage development until manufacturing?

Learning Objectives:

1. Discuss the overall goal of process modeling.

2. List experimental design concepts.

3. Discuss different modeling approaches for different requirements.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
In-Silico Scale-Up: Reduce Your Experimental Effort with Reactor Simulation

Christian Witz, Ph.D.

Head of the Computational Bioprocess Engineering Group at the Institute for Process and Particle Engineering, Graz University of Technology
BIOGRAPHY

The design, optimization and troubleshooting of industrial bioprocesses are still largely based on empirical knowledge. Thus, the goal and motivation is to base these processes on a comprehensive view of the physical and chemical processes within the reactor. By applying the latest numerical algorithms and graphical processing units (graphics cards), the inner workings of the bioreactor can be studied in detail for the first time. This lays the foundation for new apparatus designs as well as for optimization of operating parameters and process characterization on the computer. Using the example of aerated stirred bioreactors, I will show how this new simulation tool integrates and accelerates your workflow from lab to market.

Learning Objectives:

1. Explain the benefit of having a scale-up method based on first physical principles.

2. Define the usage of new CFD tools for accelerating the path from the lab to the market.

3. Identify areas where simulation can help.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Introduction to Next Generation Bioanalytics Development

Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology
BIOGRAPHY

Viral Vector gene therapy has been the focus of intense research driven by the safety profile and several clinical breakthroughs. As of March 2022, there are two viral vector gene therapies approved and many are in active clinical trials. The expected increase in demand for specific viral vectors still poses many challenges. The current talk tries to summarize the key aspects related to Research and development needs and Chemistry, Manufacturing and Control (CMC) efforts to help this growing demand. We will primarily discuss applying the different orthogonal bioanalytics to identify, monitor and control Critical Quality Attributes (CQAs) during the process development activity.

Learning Objectives:

1. Discuss different next generation bioanalytics applications.

2. Discuss unique challenges in implementing the new generation bioanalytics application.

3. Discuss and determining different Critical Quality Attributes (CQAs) for process development.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Leveraging Microscale Automated Bioreactors for the Design and Optimization of Microbial Cell Factories for the Production of Anticancer Drugs Taxol

Leonardo Rios Solis, PhD

Lecturer (Asst. Prof) in Synthetic Biology and Biochemical Engineering, Centre for Synthetic and Systems Biology, Institute for Bioengineering, The University of Edinburgh
BIOGRAPHY

Currently over 95 % of pharmaceutical products and transport fuels are derived from petroleum. Sustainable alternatives are critical to achieving net-zero emissions without detriment to quality of life. The blockbuster chemotherapeutic Taxol is naturally scarce, difficult to extract, and their chemical complexity often hinders total synthesis. Industrial scale production is therefore a monumental challenge. Microbial biosynthesis is an alternative, sustainable production route, which has been widely reported at laboratory scale. However, the translation of these breakthroughs to industrial bioprocesses remains a critical bottleneck, specially towards the recent shift into continuous flow operation. This work will exemplify an accelerated bioprocessing strategy to optimise, scale up and move towards continuous flow production of these valuable natural products using an integrated downstream/upstream continuous flow bioprocess based on solid/liquid extraction of the natural high value compounds.

Learning Objectives:

1. Discuss the advantages of using of microscale tools mimicking large scale conditions to optimize a microbial cell factory.

2. Discuss the advantages of using an integrated bioprocess approach using solid/liquid extraction to enhance the production of natural products.

3. Applying in situ solid/liquid extraction methods to recover high value compounds in microbial cell factories.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Model-Assisted Design, Transfer and Scale-Up of an Antibody-Producing Cell Culture Process

Prof. Dr.-Ing. Habil. Ralf Pörtner

Hamburg University of Technology, Institute of Bioprocess and Biosystems Engineering
BIOGRAPHY

Biopharmaceuticals produced with mammalian cells are the key drivers for the medication of former untreatable diseases. The development of their production processes is still challenging because of regulatory requirements and complex and sophisticated process strategies. Development and scale-up of cell culture processes are still mainly based on expert knowledge, one-factor-at-a-time or experimantal Design of Experiments approaches. This significantly increases the time and costs and simultaneously limits the obtained knowledge.

New design and process control strategies mainly based on mathematical process models are en route from academia to industry. The key component is a model, which aims to describe the real phenomena as simple as possible and as accurate as necessary. Model-assisted methods can therefore increase the process understanding, process control and monitoring and shorten the development times for cell culture processes.

Learning Objectives:

1. Discuss the potential of a model-assisted process design for a pharmaceutical production processes.

2. Explain coupling of statistical design of experiment (DoE) methods and mathematical models.

3. List examples for model-assisted DoE for the reduction of experimental effort as well as the model-assisted interpretation and evaluation of process management strategies.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Optimising Cell Line Development for Bioprocessing

Sami Ullah, PhD

Scientist - Tumor Biology, Department for Human and Animal Cell Lines, Leibniz Institute DSMZ (German Collection of microorganisms and cell cultures)
BIOGRAPHY

In the last decades, the upstream processing in biopharma industry has been revolutionized regarding the production of bioactive materials such as monoclonal antibodies, proteins and biotherapeutics. More and more cell lines are produced with an aim to increase the productivity and quality of biologics produced. For instance, the mammalian cell lines have gained extreme importance in production of recombinant proteins for different applications. This is in general because of the fact that mammalian cell lines allow proper protein folding and post-translational modification. Although, the process itself starts with introduction of a “gene of interest” in to the cell line, there are a number of factors which needs to be taken in to account before claiming the cell line for biologics production.

The key factors which drive this process are selection of a suitable cell type, stable cell line development, cell culture media optimization and bioreactor control strategies.

This talk will focus on the current strategies in stable cell lines development, selection of suitable media for biologics production from cell lines and the current advances in the field of upstream bioprocessing using cell lines.

Learning objectives:

1. Explain how cell lines are produced and selected for biologics production.

2. Discuss what critical role the media for cell cultivation play in upstream processing.

3. Discuss what the new technologies are that can better the quality of bioprocessing as well as shorten the time for cell lines development.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE

Downstream Processing
In-Silico Scale-Up: Reduce Your Experimental Effort with Reactor Simulation

Christian Witz, Ph.D.

Head of the Computational Bioprocess Engineering Group at the Institute for Process and Particle Engineering, Graz University of Technology
BIOGRAPHY

The design, optimization and troubleshooting of industrial bioprocesses are still largely based on empirical knowledge. Thus, the goal and motivation is to base these processes on a comprehensive view of the physical and chemical processes within the reactor. By applying the latest numerical algorithms and graphical processing units (graphics cards), the inner workings of the bioreactor can be studied in detail for the first time. This lays the foundation for new apparatus designs as well as for optimization of operating parameters and process characterization on the computer. Using the example of aerated stirred bioreactors, I will show how this new simulation tool integrates and accelerates your workflow from lab to market.

Learning Objectives:

1. Explain the benefit of having a scale-up method based on first physical principles.

2. Define the usage of new CFD tools for accelerating the path from the lab to the market.

3. Identify areas where simulation can help.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
APR 06, 2022 9:00 AM PDT

Keynote Presentation: Continuous Bioprocessing - New Challenges and Opportunities for Membrane Technology

Andrew L. Zydney, PhD

Bayard D. Kunkle Chair and Professor of Chemical Engineering, Director, Membrane Science, Engineering and Technology (MAST) Center, The Pennsylvania State University
BIOGRAPHY

There is growing interest in the development of integrated continuous bioprocesses for the production of important biotherapeutics due to the potential for enhanced productivity, greater flexibility, and improved product quality. The transition from batch to continuous bioprocessing requires a major re-thinking of the downstream purification process, creating exciting new opportunities for membrane technology. This talk will focus on the use of continuous countercurrent staged membrane systems for initial product capture and for final formulation. Continuous Countercurrent Tangential Chromatography (CCTC) provides truly continuous steady-state product capture and purification using a column-free system in which the chromatographic operations are conducted on a flowing slurry using hollow fiber membranes to control the resin flow. Results using a Protein A affinity resin show high levels of host cell protein removal from a monoclonal antibody product, with the countercurrent staged providing significantly greater throughput with improved product yield and purification. A similar approach can be used for continuous selective precipitation of monoclonal antibodies, completely eliminating the high cost of the affinity resin. Countercurrent staged diafiltration has been developed as a new strategy for providing high levels of buffer exchange in a single-pass continuous format. These examples highlight how one can adapt membrane systems to continuous bioprocessing, providing exciting opportunities for improved manufacturing of high-value biopharmaceuticals.

Learning Objectives:

1. Explain the benefits of implementing continuous bioprocessing.

2. Identify the opportunities for using countercurrent staging to enhance the performance of downstream processes.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
APR 06, 2022 11:30 AM PDT

Keynote Presentation: A Generic Manufacturing Platform for Downstream Processing on Non-mab Proteins

Alois Jungbauer, PhD

Professor, Department of Biotechnology, University of Natural Resources and Life Sciences, Institute of Bioprocess Science and Engineering
BIOGRAPHY

The vast structural diversity of proteins is responsible for their functional versatility, but also makes their expression and purification a demanding task. Tagging proteins with affinity tags can overcome the complexity of conventional purification by enabling affinity chromatography. An overview will be given for the purification of tagged proteins and then a purification system using a circular permutated caspase will be described in detail. It has been developed for process fusion protein processing to generate an authentic N-terminus for all 20 amino acids. The system employs widely available affinity chromatography resins, and a simple process can be used regardless of the specific nature of the protein of interest.

Learning Objectives:

1. Explain the processing of fusion proteins and non-mAb proteins.

2. Discuss the generation of an authentic N-terminus.

3. Discuss the effect of enzyme kinetics on process of fusion proteins.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Upstream Processing
Optimising Cell Line Development for Bioprocessing

Sami Ullah, PhD

Scientist - Tumor Biology, Department for Human and Animal Cell Lines, Leibniz Institute DSMZ (German Collection of microorganisms and cell cultures)
BIOGRAPHY

In the last decades, the upstream processing in biopharma industry has been revolutionized regarding the production of bioactive materials such as monoclonal antibodies, proteins and biotherapeutics. More and more cell lines are produced with an aim to increase the productivity and quality of biologics produced. For instance, the mammalian cell lines have gained extreme importance in production of recombinant proteins for different applications. This is in general because of the fact that mammalian cell lines allow proper protein folding and post-translational modification. Although, the process itself starts with introduction of a “gene of interest” in to the cell line, there are a number of factors which needs to be taken in to account before claiming the cell line for biologics production.

The key factors which drive this process are selection of a suitable cell type, stable cell line development, cell culture media optimization and bioreactor control strategies.

This talk will focus on the current strategies in stable cell lines development, selection of suitable media for biologics production from cell lines and the current advances in the field of upstream bioprocessing using cell lines.

Learning objectives:

1. Explain how cell lines are produced and selected for biologics production.

2. Discuss what critical role the media for cell cultivation play in upstream processing.

3. Discuss what the new technologies are that can better the quality of bioprocessing as well as shorten the time for cell lines development.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Leveraging Microscale Automated Bioreactors for the Design and Optimization of Microbial Cell Factories for the Production of Anticancer Drugs Taxol

Leonardo Rios Solis, PhD

Lecturer (Asst. Prof) in Synthetic Biology and Biochemical Engineering, Centre for Synthetic and Systems Biology, Institute for Bioengineering, The University of Edinburgh
BIOGRAPHY

Currently over 95 % of pharmaceutical products and transport fuels are derived from petroleum. Sustainable alternatives are critical to achieving net-zero emissions without detriment to quality of life. The blockbuster chemotherapeutic Taxol is naturally scarce, difficult to extract, and their chemical complexity often hinders total synthesis. Industrial scale production is therefore a monumental challenge. Microbial biosynthesis is an alternative, sustainable production route, which has been widely reported at laboratory scale. However, the translation of these breakthroughs to industrial bioprocesses remains a critical bottleneck, specially towards the recent shift into continuous flow operation. This work will exemplify an accelerated bioprocessing strategy to optimise, scale up and move towards continuous flow production of these valuable natural products using an integrated downstream/upstream continuous flow bioprocess based on solid/liquid extraction of the natural high value compounds.

Learning Objectives:

1. Discuss the advantages of using of microscale tools mimicking large scale conditions to optimize a microbial cell factory.

2. Discuss the advantages of using an integrated bioprocess approach using solid/liquid extraction to enhance the production of natural products.

3. Applying in situ solid/liquid extraction methods to recover high value compounds in microbial cell factories.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Manufacturing
Model-Assisted Design, Transfer and Scale-Up of an Antibody-Producing Cell Culture Process

Prof. Dr.-Ing. Habil. Ralf Pörtner

Hamburg University of Technology, Institute of Bioprocess and Biosystems Engineering
BIOGRAPHY

Biopharmaceuticals produced with mammalian cells are the key drivers for the medication of former untreatable diseases. The development of their production processes is still challenging because of regulatory requirements and complex and sophisticated process strategies. Development and scale-up of cell culture processes are still mainly based on expert knowledge, one-factor-at-a-time or experimantal Design of Experiments approaches. This significantly increases the time and costs and simultaneously limits the obtained knowledge.

New design and process control strategies mainly based on mathematical process models are en route from academia to industry. The key component is a model, which aims to describe the real phenomena as simple as possible and as accurate as necessary. Model-assisted methods can therefore increase the process understanding, process control and monitoring and shorten the development times for cell culture processes.

Learning Objectives:

1. Discuss the potential of a model-assisted process design for a pharmaceutical production processes.

2. Explain coupling of statistical design of experiment (DoE) methods and mathematical models.

3. List examples for model-assisted DoE for the reduction of experimental effort as well as the model-assisted interpretation and evaluation of process management strategies.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
From Experiments, Data, Hybrid Models, and Digital Twins. Several Up- and Downstream Success Stories Highlighting the Benefits of Using Advanced Process Modeling

Dr. Mark Dürkop

CEO Novasign GmbH, Project Lead BOKU - Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna
BIOGRAPHY

The application of modeling tools to better understand and control bioprocess development and manufacturing has become a hot topic within the last few years. However, what do we actually need? Is it just about data and powerful modeling algorithms, or is there more to consider to accurately describe a process and transfer the knowledge and model structure from early-stage development until manufacturing?

Learning Objectives:

1. Discuss the overall goal of process modeling.

2. List experimental design concepts.

3. Discuss different modeling approaches for different requirements.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
Cell, Gene and Nucleic Therapies (Novel Modalities)
Introduction to Next Generation Bioanalytics Development

Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology
BIOGRAPHY

Viral Vector gene therapy has been the focus of intense research driven by the safety profile and several clinical breakthroughs. As of March 2022, there are two viral vector gene therapies approved and many are in active clinical trials. The expected increase in demand for specific viral vectors still poses many challenges. The current talk tries to summarize the key aspects related to Research and development needs and Chemistry, Manufacturing and Control (CMC) efforts to help this growing demand. We will primarily discuss applying the different orthogonal bioanalytics to identify, monitor and control Critical Quality Attributes (CQAs) during the process development activity.

Learning Objectives:

1. Discuss different next generation bioanalytics applications.

2. Discuss unique challenges in implementing the new generation bioanalytics application.

3. Discuss and determining different Critical Quality Attributes (CQAs) for process development.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE
APR 06, 2022 10:30 AM PDT

Panel Presentation: An Overview of Gene Therapy Manufacturing: Development through Commercial Production

Kevin G. McGarry, Jr., PhD, Samir Acharya, PhD

The field of gene therapy is young and rapidly evolving, with new information discovered every day and an ever-increasing number of novel therapies entering various phases of clinical trials. For over 15 years, Nationwide Children’s Hospital in Columbus, Ohio, has performed as a research leader in the gene therapy field, and Andelyn Biosciences was born of this expertise in 2020. As gene therapy continues to grow, scientists must continue to learn from the rich, albeit recent, history and consider new insights from early developmental research through commercial production of a gene therapy product. There are high-level points and potential challenges to consider, including early development and selection of a viral vector, vector design, strategies for upstream and downstream process and platform development, in-process characterization of a product, and scalability, among others. This overview will cover these topics through the process of bringing a new product to the clinic.

Learning Objectives:

1. Explain what is gene therapy is.

2. Explain what steps are involved for getting a gene therapy product to the clinic.

3. Discuss development and manufacturing processes, analytics, and potential challenges.

SEE ABSTRACT HIDE ABSTRACT | Continuing Education: P.A.C.E. CE | Florida CE

Kevin G. McGarry, Jr., PhD
Manager, Analytical Development, Andelyn Biosciences
BIOGRAPHY

Samir Acharya, PhD
Associate Director, Process Development, Andelyn Biosciences
BIOGRAPHY

Speakers

Samir Acharya, PhD

Associate Director, Process Development, Andelyn Biosciences

BIOGRAPHY
Dr. Mark Dürkop

CEO Novasign GmbH, Project Lead BOKU - Department of Biotechnology, University of Natural Resources and Life Sciences, Vienna

BIOGRAPHY
Alois Jungbauer, PhD

Professor, Department of Biotechnology, University of Natural Resources and Life Sciences, Institute of Bioprocess Science and Engineering

BIOGRAPHY
Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology

BIOGRAPHY
Kevin G. McGarry, Jr., PhD

Manager, Analytical Development, Andelyn Biosciences

BIOGRAPHY
Prof. Dr.-Ing. Habil. Ralf Pörtner

Hamburg University of Technology, Institute of Bioprocess and Biosystems Engineering

BIOGRAPHY
Leonardo Rios Solis, PhD

Lecturer (Asst. Prof) in Synthetic Biology and Biochemical Engineering, Centre for Synthetic and Systems Biology, Institute for Bioengineering, The University of Edinburgh

BIOGRAPHY
Sami Ullah, PhD

Scientist - Tumor Biology, Department for Human and Animal Cell Lines, Leibniz Institute DSMZ (German Collection of microorganisms and cell cultures)

BIOGRAPHY
Christian Witz, Ph.D.

Head of the Computational Bioprocess Engineering Group at the Institute for Process and Particle Engineering, Graz University of Technology

BIOGRAPHY
Andrew L. Zydney, PhD

Bayard D. Kunkle Chair and Professor of Chemical Engineering, Director, Membrane Science, Engineering and Technology (MAST) Center, The Pennsylvania State University

BIOGRAPHY