APR 8, 2020

BioProcessing 2020

LabRoots is pleased to announce the 2nd Annual BioProcessing Virtual Event! Join us for this free, one-day event on April 8, 2020 as we discuss upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing.

This years event will include the following tracks and topics:

Upstream Processing

Optimizing Cell Culture
Bioproduction
Optimizing Cell Line Development

Downstream Processing

Continuous Processing
Recovery & Purification
Impurities in Biologics

Analytical & Quality

Analytical Development
Process Characterization & Control

Cell and Gene Therapies

Cell Therapy Manufacturing/Analytics
Gene Therapy Manufacturing/Analytics
Regulatory Considerations

Manufacturing

Continuous Processing
Digital Biomanufacturing

Our virtual conference allows you to participate in a global setting with no travel or cost to you. The event will remain open 6 months from the date of the live event. The webinars will be available for unlimited on-demand viewing. This virtual conference also offers increased reach for the global microbiology community with a high degree of interaction through live-streaming video and chat sessions.

Like the 2019 conference, this event will be produced on our robust platform, allowing you to watch, learn and connect seamlessly across all desktop or mobile devices. Equipped with gamification and point system, you can now move around the entire event, earning points for a chance to win one of LabRoots' most popular T-shirts. Please note that our Store is temporarily closed due to COVID-19. We will alert you when you store re-opens and you can order your t-shirt.

Call for Posters — Virtual poster sessions offer the opportunity to present data to a global audience via a PDF poster and video summary, and discuss results with interested colleagues through email. Plan now to have your poster included in the 2020 BioProcessing Virtual Event. Submission is free. Submit your abstract here.

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.

Use #LRbioprocessing to follow the conversation!

Speakers

Buzz Lobbezoo

Product Support and Development Manager at Astrea Bioseparations Ltd.
BIOGRAPHY
Sue Behrens

George B. and Joy Rathmann Professor in Bioprocessing and Director, Amgen Bioprocessing Center
BIOGRAPHY
Dr. Mark Dürkop

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

Scientist, Technical Operations, Sana Biotechnology
BIOGRAPHY
Robert Kruse, MD, PhD

Resident Physician, John Hopkins
BIOGRAPHY
Moo Sun Hong, MS

Researcher at the Massachusetts Institute of Technology (MIT)
BIOGRAPHY
David Schaffer, PhD

Professor of Chemical and Biomolecular Engineering, University of California, Berkeley
BIOGRAPHY
John E. Schiel, PhD

Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology
BIOGRAPHY

Show Resources

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Presentations

Download Agenda

APR 08, 2020 9:00 AM PDT

Case Study: From Ligand discovery to developing a purification platform and delivering GMP-ready affinity chromatography columns

Buzz Lobbezoo

Product Support and Development Manager at Astrea Bioseparations Ltd.
BIOGRAPHY

This presentation is about a client-focused approach used to find an all synthetic ligand which is developed into an affinity adsorbent – followed by working with the client to develop the affinity chromatography strategy and deliver a robust purification platform with GMP-ready columns.

Learning Objectives:

1. To understand the requirements for developing an affinity adsorbent for purification of biotherapeutics

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
APR 08, 2020 7:30 AM PDT

Keynote Presentation: New Paradigms in moving toward Point-of-Care Cell Therapy Services in the Hospital

Robert Kruse, MD, PhD

Resident Physician, John Hopkins
BIOGRAPHY

Genetically-modified cell therapies are revolutionizing medicine, offering new opportunities to treat cancer patients and potentially many other diseases. The process of producing gene-modified cell therapies, in particular CAR-T cells, derived from patients is very complex, however, restricting widespread use. The current process involves collection of T cells by apheresis, and shipment from the hospital to a centralized manufacturing site, where cells transduced with gene and grown for 2-3 weeks, before returning to the hospital for infusion into the patient. The significant complexity, freeze/thaw cycles, shipments, and delay in getting therapies pose challenges. As an alternative, a point of care cell therapy production within hospitals would obviate the need for shipping and may reduce the time to get therapies to patients. Automated manufacturing machines will be essential in this paradigm, in order to standardize cellular manufacturing across all hospitals and to deliver the same products to patients. A distributed point-of-care paradigm may ultimately provide an avenue to scale cell therapies to more patients and expand into new clinical indications.

Learning Objectives:

1. Define the mechanism of cell therapies and their clinical indications

2. Identify the key bottlenecks in the delivery of cell therapies to patients today

3. Explain how point of care cell therapy production in hospitals could work

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Collaborative Education for Talent of the Future

Sue Behrens

George B. and Joy Rathmann Professor in Bioprocessing and Director, Amgen Bioprocessing Center
BIOGRAPHY

Strong performance for a Facility of the Future for the Life Sciences industry requires more than optimal manufacturing process development and facility design. The sector encompasses a diverse set of products, technologies and platforms which require application of multi-disciplinary skills. Successful organizations must attract technical and operational leaders with a combination of science, engineering, information and business expertise. Company growth can be hindered by availability of sufficiently skilled candidates and the implementation of higher levels of technology to achieve Pharm 4.0 is expected to further constrain an already limited talent pool. It is critical to focus on selecting the right employees from the start, while continuing to build competences through internal and external training opportunities. Many candidates begin their career with a strong foundation which can be rapidly built upon to ensure success in industry. This presentation will describe collaborative opportunities for talent development for the industry, including academic partners (e.g. KGI Amgen Bioprocessing Center) and programs funded by federal (e.g. NIIMBL) or state (e.g. BTEC) grants.

Learning Objectives:

1. Understand the current state of talent availability for Biopharmaceutical Manufacturing

2. Define the requirements of Pharma 4.0 and impact on demand for talent

3. Recognize shift in education and training to bridge to success in a digitized manufacturing environment

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Directed Evolution of Next-Generation AAV Vector Systems for Clinical Gene Therapy

David Schaffer, PhD

Professor of Chemical and Biomolecular Engineering, University of California, Berkeley
BIOGRAPHY

There has been an increasing number of successful gene therapy clinical trials, leading to regulatory approvals of numerous gene therapy products, in particular ones based on the adeno-associated virus (AAV). That said, vectors based on natural versions of AAV face a number of delivery challenges that limit their efficacy and will thus preclude the extension of these successes to the majority of human diseases. These delivery limitations arise since the parent viruses upon which these vectors are based were not evolved by nature for our convenience to use as human therapeutics. We have been developing and implementing a high throughput approach termed directed evolution – involving the iterative genetic diversification of a viral genome and functional selection for desired properties – to engineer highly optimized variants of AAV for a broad range of cell and tissue targets.

In parallel, the advent of genome editing technologies such as the CRISPR/Cas9 system raise the possibility of using gene delivery not only for gene replacement but for repair or knockout of endogenous genes. We have thus been combining engineered AAVs with CRISPR/Cas9 for a range of applications, in particular, to treat central nervous system disorders. The integration of these new technologies – Cas9 cargo with AAV delivery – can enable a broad range of basic and therapeutic applications.

Learning Objectives:

1. To gain an understanding of how preclinical and clinical research in gene therapy is leading to strong advances and clinical approvals

2. To discuss how improvements in delivery technologies, such as engineered AAV delivery vectors, are still needed to fully unlock the potential of gene therapy and genome editing

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Droplet Digital PCR as a tool for gene therapy application

Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology
BIOGRAPHY

Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the recent years, numerous articles of new digital PCR methods have been published. Considering the development work into reliable analytical methods suitable for diagnostics requires their validation for the intended use. The results of an in-house evaluation of a droplet digital PCR compared to other technologies will be presented in application to different genomic assays applied in gene therapy.

Learning Objectives:

1) Introduction to Droplet Digital PCR

2) Explain the need for Droplet Digital PCR compared to current methodologies in different gene therapy platforms

3) Present the key evaluations required to establish the assay for research and good manufacturing purpose.

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Hybrid Modeling and Intensified DoE Enabling Faster Process Development, Soft Sensors and Model Predictive Control

Dr. Mark Dürkop

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

Within this talk the advantages of using intensified Design of experiments (iDoE) in combination with hybrid modeling will be demonstrated. In detailed upstream and downstream showcases the applied hybrid modeling structure significantly reduced the development times while simultaneously enabled the application of soft-sensors and digital twin to screen for ideal process conditions. While the downstream hybrid model could be used for different operation modes and simple model predictive control, the upstream iDoE approach reduced the experimental effort by 66%, significantly reducing development costs.

Learning Objectives:

1. Faster Drug Development by modeling along the whole value chain

2. Hybrid Modeling to strengthen bioprocess understanding

3. intensified Design of Experiments to speed up process characterization

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Macroscopic Modeling of Bioreactors for Recombinant Protein Producing Pichia pastoris in Defined Medium

Moo Sun Hong, MS

Researcher at the Massachusetts Institute of Technology (MIT)
BIOGRAPHY

Bioreactor modeling can inform understanding of cellular metabolism—including aspects of growth kinetics, productivity, media consumption, and metabolite secretion—and can be used to optimize bioreactor operations. Models for bioreactors are developed with different level of details and complexity depending on their purpose. For methylotrophic yeast Pichia pastoris, which is widely used as the microbial host for recombinant protein production, complex cellular models such as genomic-scale metabolic models have been developed to describe detailed cellular metabolism. These models, however, have too many parameters to be accurately estimated from experimental data. As such, most of the parameters are highly uncertain, even when additional assumptions and/or approximations are made such as the metabolic fluxes being at steady state. In contrast, macroscopic models can yield a reasonable description of the bioreactor while using simpler mathematical formulations with low computational costs. These types of models can also facilitate real-time applications such as adaptive parameter estimation and model predictive control.

This presentation describes an extensive macroscopic bioreactor model for substrates, biomass, total protein, other medium components, and off-gas components. Species and elemental balances are introduced to describe uptake and evolution rates for medium components and off-gas components. Additionally, a pH model is constructed using an overall charge balance, acid/base equilibria, and activity coefficients to describe production of recombinant protein and precipitation of medium components. The extent of run-to-run variability is modeled by distributions of a subset of the model parameters, which are estimated using the maximum likelihood method. The uncertainty description in this macroscopic bioreactor model identifies the model parameters that have large variability and provides guidance as to which aspects of cellular metabolism should be the focus of additional experimental studies. The model for medium components with pH and precipitation can be used for improving the chemically defined medium by minimizing the amount of components needed while meeting cellular requirements.

Learning Objectives:

1. Discuss current trends in biopharmaceutical manufacturing operations and control

2. Describe a mathematical model that incorporates solution chemistry to more accurately predict bioreactor data

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
The NISTmAb and Related Biopharmaceutical Resources

John Schiel, PhD

Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology
BIOGRAPHY

The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines. Lifecycle appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators, an effort facilitated by widely available test metrics. Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights. The NISTmAb IgG1k is a NIST Reference Material (RM 8671) intended to fill that void. The NISTmAb embodies the quality and characteristics of a biopharmaceutical product, is widely available to the biopharmaceutical community, and is an open innovation tool for development and dissemination of results. The utility of the NISTmAb as an industry-wide test metric to evaluate performance of emerging technologies, foster collaboration, and spur innovation will also be discussed.

Learning Objectives:

1. Familiarization with the NIST monoclonal antibody (NISTmAb) and its utility in advancing biopharmaceutical analytics

2. Gain knowledge about the many applications of multi-attribute mass spectrometry methods and opportunities/challenges facing implementation into QC.

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar

Cell and Gene Therapies
Directed Evolution of Next-Generation AAV Vector Systems for Clinical Gene Therapy

David Schaffer, PhD

Professor of Chemical and Biomolecular Engineering, University of California, Berkeley
BIOGRAPHY

There has been an increasing number of successful gene therapy clinical trials, leading to regulatory approvals of numerous gene therapy products, in particular ones based on the adeno-associated virus (AAV). That said, vectors based on natural versions of AAV face a number of delivery challenges that limit their efficacy and will thus preclude the extension of these successes to the majority of human diseases. These delivery limitations arise since the parent viruses upon which these vectors are based were not evolved by nature for our convenience to use as human therapeutics. We have been developing and implementing a high throughput approach termed directed evolution – involving the iterative genetic diversification of a viral genome and functional selection for desired properties – to engineer highly optimized variants of AAV for a broad range of cell and tissue targets.

In parallel, the advent of genome editing technologies such as the CRISPR/Cas9 system raise the possibility of using gene delivery not only for gene replacement but for repair or knockout of endogenous genes. We have thus been combining engineered AAVs with CRISPR/Cas9 for a range of applications, in particular, to treat central nervous system disorders. The integration of these new technologies – Cas9 cargo with AAV delivery – can enable a broad range of basic and therapeutic applications.

Learning Objectives:

1. To gain an understanding of how preclinical and clinical research in gene therapy is leading to strong advances and clinical approvals

2. To discuss how improvements in delivery technologies, such as engineered AAV delivery vectors, are still needed to fully unlock the potential of gene therapy and genome editing

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
APR 08, 2020 7:30 AM PDT

Keynote Presentation: New Paradigms in moving toward Point-of-Care Cell Therapy Services in the Hospital

Robert Kruse, MD, PhD

Resident Physician, John Hopkins
BIOGRAPHY

Genetically-modified cell therapies are revolutionizing medicine, offering new opportunities to treat cancer patients and potentially many other diseases. The process of producing gene-modified cell therapies, in particular CAR-T cells, derived from patients is very complex, however, restricting widespread use. The current process involves collection of T cells by apheresis, and shipment from the hospital to a centralized manufacturing site, where cells transduced with gene and grown for 2-3 weeks, before returning to the hospital for infusion into the patient. The significant complexity, freeze/thaw cycles, shipments, and delay in getting therapies pose challenges. As an alternative, a point of care cell therapy production within hospitals would obviate the need for shipping and may reduce the time to get therapies to patients. Automated manufacturing machines will be essential in this paradigm, in order to standardize cellular manufacturing across all hospitals and to deliver the same products to patients. A distributed point-of-care paradigm may ultimately provide an avenue to scale cell therapies to more patients and expand into new clinical indications.

Learning Objectives:

1. Define the mechanism of cell therapies and their clinical indications

2. Identify the key bottlenecks in the delivery of cell therapies to patients today

3. Explain how point of care cell therapy production in hospitals could work

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Manufacturing
Hybrid Modeling and Intensified DoE Enabling Faster Process Development, Soft Sensors and Model Predictive Control

Dr. Mark Dürkop

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

Within this talk the advantages of using intensified Design of experiments (iDoE) in combination with hybrid modeling will be demonstrated. In detailed upstream and downstream showcases the applied hybrid modeling structure significantly reduced the development times while simultaneously enabled the application of soft-sensors and digital twin to screen for ideal process conditions. While the downstream hybrid model could be used for different operation modes and simple model predictive control, the upstream iDoE approach reduced the experimental effort by 66%, significantly reducing development costs.

Learning Objectives:

1. Faster Drug Development by modeling along the whole value chain

2. Hybrid Modeling to strengthen bioprocess understanding

3. intensified Design of Experiments to speed up process characterization

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Collaborative Education for Talent of the Future

Sue Behrens

George B. and Joy Rathmann Professor in Bioprocessing and Director, Amgen Bioprocessing Center
BIOGRAPHY

Strong performance for a Facility of the Future for the Life Sciences industry requires more than optimal manufacturing process development and facility design. The sector encompasses a diverse set of products, technologies and platforms which require application of multi-disciplinary skills. Successful organizations must attract technical and operational leaders with a combination of science, engineering, information and business expertise. Company growth can be hindered by availability of sufficiently skilled candidates and the implementation of higher levels of technology to achieve Pharm 4.0 is expected to further constrain an already limited talent pool. It is critical to focus on selecting the right employees from the start, while continuing to build competences through internal and external training opportunities. Many candidates begin their career with a strong foundation which can be rapidly built upon to ensure success in industry. This presentation will describe collaborative opportunities for talent development for the industry, including academic partners (e.g. KGI Amgen Bioprocessing Center) and programs funded by federal (e.g. NIIMBL) or state (e.g. BTEC) grants.

Learning Objectives:

1. Understand the current state of talent availability for Biopharmaceutical Manufacturing

2. Define the requirements of Pharma 4.0 and impact on demand for talent

3. Recognize shift in education and training to bridge to success in a digitized manufacturing environment

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Analytical & Quality
Macroscopic Modeling of Bioreactors for Recombinant Protein Producing Pichia pastoris in Defined Medium

Moo Sun Hong, MS

Researcher at the Massachusetts Institute of Technology (MIT)
BIOGRAPHY

Bioreactor modeling can inform understanding of cellular metabolism—including aspects of growth kinetics, productivity, media consumption, and metabolite secretion—and can be used to optimize bioreactor operations. Models for bioreactors are developed with different level of details and complexity depending on their purpose. For methylotrophic yeast Pichia pastoris, which is widely used as the microbial host for recombinant protein production, complex cellular models such as genomic-scale metabolic models have been developed to describe detailed cellular metabolism. These models, however, have too many parameters to be accurately estimated from experimental data. As such, most of the parameters are highly uncertain, even when additional assumptions and/or approximations are made such as the metabolic fluxes being at steady state. In contrast, macroscopic models can yield a reasonable description of the bioreactor while using simpler mathematical formulations with low computational costs. These types of models can also facilitate real-time applications such as adaptive parameter estimation and model predictive control.

This presentation describes an extensive macroscopic bioreactor model for substrates, biomass, total protein, other medium components, and off-gas components. Species and elemental balances are introduced to describe uptake and evolution rates for medium components and off-gas components. Additionally, a pH model is constructed using an overall charge balance, acid/base equilibria, and activity coefficients to describe production of recombinant protein and precipitation of medium components. The extent of run-to-run variability is modeled by distributions of a subset of the model parameters, which are estimated using the maximum likelihood method. The uncertainty description in this macroscopic bioreactor model identifies the model parameters that have large variability and provides guidance as to which aspects of cellular metabolism should be the focus of additional experimental studies. The model for medium components with pH and precipitation can be used for improving the chemically defined medium by minimizing the amount of components needed while meeting cellular requirements.

Learning Objectives:

1. Discuss current trends in biopharmaceutical manufacturing operations and control

2. Describe a mathematical model that incorporates solution chemistry to more accurately predict bioreactor data

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Droplet Digital PCR as a tool for gene therapy application

Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology
BIOGRAPHY

Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the recent years, numerous articles of new digital PCR methods have been published. Considering the development work into reliable analytical methods suitable for diagnostics requires their validation for the intended use. The results of an in-house evaluation of a droplet digital PCR compared to other technologies will be presented in application to different genomic assays applied in gene therapy.

Learning Objectives:

1) Introduction to Droplet Digital PCR

2) Explain the need for Droplet Digital PCR compared to current methodologies in different gene therapy platforms

3) Present the key evaluations required to establish the assay for research and good manufacturing purpose.

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
The NISTmAb and Related Biopharmaceutical Resources

John Schiel, PhD

Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology
BIOGRAPHY

The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines. Lifecycle appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators, an effort facilitated by widely available test metrics. Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights. The NISTmAb IgG1k is a NIST Reference Material (RM 8671) intended to fill that void. The NISTmAb embodies the quality and characteristics of a biopharmaceutical product, is widely available to the biopharmaceutical community, and is an open innovation tool for development and dissemination of results. The utility of the NISTmAb as an industry-wide test metric to evaluate performance of emerging technologies, foster collaboration, and spur innovation will also be discussed.

Learning Objectives:

1. Familiarization with the NIST monoclonal antibody (NISTmAb) and its utility in advancing biopharmaceutical analytics

2. Gain knowledge about the many applications of multi-attribute mass spectrometry methods and opportunities/challenges facing implementation into QC.

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar
Downstream Processing
APR 08, 2020 9:00 AM PDT

Case Study: From Ligand discovery to developing a purification platform and delivering GMP-ready affinity chromatography columns

Buzz Lobbezoo

Product Support and Development Manager at Astrea Bioseparations Ltd.
BIOGRAPHY

This presentation is about a client-focused approach used to find an all synthetic ligand which is developed into an affinity adsorbent – followed by working with the client to develop the affinity chromatography strategy and deliver a robust purification platform with GMP-ready columns.

Learning Objectives:

1. To understand the requirements for developing an affinity adsorbent for purification of biotherapeutics

SEE ABSTRACT HIDE ABSTRACT

Watch Webinar

Speakers

Buzz Lobbezoo

Product Support and Development Manager at Astrea Bioseparations Ltd.

BIOGRAPHY
Sue Behrens

George B. and Joy Rathmann Professor in Bioprocessing and Director, Amgen Bioprocessing Center

BIOGRAPHY
Dr. Mark Dürkop

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

BIOGRAPHY
Nagarjun Kasaraneni, PhD

Scientist, Technical Operations, Sana Biotechnology

BIOGRAPHY
Robert Kruse, MD, PhD

Resident Physician, John Hopkins

BIOGRAPHY
Moo Sun Hong, MS

Researcher at the Massachusetts Institute of Technology (MIT)

BIOGRAPHY
David Schaffer, PhD

Professor of Chemical and Biomolecular Engineering, University of California, Berkeley

BIOGRAPHY
John E. Schiel, PhD

Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology

BIOGRAPHY

BioProcessing 2020

Buzz Lobbezoo

Sue Behrens

Dr. Mark Dürkop

Nagarjun Kasaraneni, PhD

Robert Kruse, MD, PhD

Moo Sun Hong, MS

David Schaffer, PhD

John E. Schiel, PhD