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Key Sessions

Jason Walther PhD

Developing and Implementing a Commercially Viable Integrated and Continuous Process

Sanofi

Thomas Seewoester, PhD

Bioprocessing 4.0 – Digital Technologies Are Transforming Biologics Manufacturing

Amgen, Inc.

Sep 06
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Showing of Streams
Showing of Streams
Showing of Streams
12:35pm - 1:40pm

Networking Luncheon in the Poster & Exhibit Hall

Showing of Streams
Showing of Streams
3:15pm - 4:00pm

Networking Refreshment Break in the Poster & Exhibit Hall

Showing of Streams
5:40pm - 5:45pm
Close of Day

Close of Day

7:15am - 7:45am 30 mins
Main Conference
Morning Roundtable Discussions with Light Continental Breakfast
7:15am - 7:45am 30 mins
Workshop
Technology Workshop with Light Continental Breakfast
8:00am - 8:10am 10 mins
Keynote Presentations
Chairperson's Opening Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
more
8:10am - 8:55am 45 mins
Keynote Presentations
Developing and Implementing a Commercially Viable Integrated and Continuous Process
  • Jason Walther PhD - Principal Scientist, Downstream Bioprocess Development, Sanofi
more
8:55am - 9:40am 45 mins
Keynote Presentations
Bioprocessing 4.0 – Digital Technologies Are Transforming Biologics Manufacturing
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
more

Manufacturing processes for biologics have been optimized for the last 100 years. Revolutionary steps in the last 20 years included the introduction of process platforms for monoclonal antibodies, the perfection of large scale fed-batch processes and recently more economic scale-out approaches in single-use systems. Digital technologies in contrast are following a much more rapid and exponential innovation curve. Understanding and leveraging digital technologies, looking beyond the molecule and refining mountains of data into instantaneously and globally available insights and wisdom will be a differentiating factor that is starting to transform our industry in the same way as it has other industries.

9:40am - 10:25am 45 mins
Keynote Presentations
Networking Refreshment Break in Poster & Exhibit Hall
10:25am - 10:30am 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
more
10:25am - 10:30am 5 mins
Recovery & Purification
Chairperson's Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
more
10:25am - 10:30am 5 mins
Analytical & Quality
Chairperson's Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
more
10:25am - 10:30am 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Kenneth Green, PhD - Scientist, Industry Consultant
more
10:25am - 10:30am 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Kenneth Green, PhD - Scientist, Industry Consultant
more
10:25am - 10:30am 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Dingjiang Liu, PhD - Director, Formulation Development, Regeneron Pharmaceuticals
more
10:25am - 12:00pm 95 mins
New Technologies and Innovation Roundtable
New Technology and Innovation Roundtable
  • Lynne Frick - Founder, Bioguides
more

Join an interactive session of senior industry professionals, all members of the Boston based BioInnovation Group, who volunteer their time to actively seek out and identify emerging technologies, or technologies in other industries, that could have a significant impact in Life Sciences. Their mission is to advance these new and emerging technologies and biotools by providing expert opinions, ideas on applications and in some cases, development advice to improve the chances of success and ultimate adoption of new technologies into the industry. There will be a short introductory session followed by the opportunity to explore six emerging new technologies in small interactive round tables as participants rotate through ‘tables’ of their choosing staffed by members of the BioInnovation group and the entrepreneurs/developers of these new technologies. 

10:30am - 11:00am 30 mins
Cell Culture & Upstream Processing
Implementing Continuous Processing in Manufacturing
  • Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
more
10:30am - 11:00am 30 mins
Recovery & Purification
Implementing Continuous Processing in Manufacturing
  • Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
more
10:30am - 11:00am 30 mins
Analytical & Quality
Implementing Continuous Processing in Manufacturing
  • Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
more
10:30am - 11:00am 30 mins
Speed from Gene to Market
Screening/Scale Models for Accelerating Process Development Cycle Times
  • Hang Yuan, PhD - Head of Global Upstream Process Development, Shire
more
10:30am - 11:00am 30 mins
Manufacturing Strategy
Screening/Scale Models for Accelerating Process Development Cycle Times
  • Hang Yuan, PhD - Head of Global Upstream Process Development, Shire
more
10:30am - 10:50am 20 mins
Drug Product, Fill-Finish & Formulations
An Inter-Company Perspective on Biopharmaceutical Drug Product Robustness Studies
  • Dingjiang Liu, PhD - Director, Formulation Development, Regeneron Pharmaceuticals
more

Drug Product (DP) robustness studies ensure a product meets quality standards when formulation and process parameters are within established ranges. The BioPhorum Development Group (BPDG) authored a commentary on DP robustness (S. Morar-Mitrica, et al, J.Pharm.Sci. (2018), 107: 529-542) focused on the current scope, design and execution of biopharmaceutical DP robustness studies. Common themes were identified with regard to the use of DP robustness studies, with integrated case studies.

10:50am - 11:15am 25 mins
Drug Product, Fill-Finish & Formulations
Progress and Challenges in Automation-Assisted Formulation Development at Genentech
  • Jia Sun - Engineer, Genentech
more

As protein therapeutics become more structurally diverse and the development timeline gets more compressed, the need to evaluate a wider range of formulation conditions increases. One consideration is using high-throughput technology for formulation selections, and this technology has been successfully employed in many other pharmaceutical process development areas such as cell culture and protein purification. In spite of this, there has been limited implementation of this technology in the formulation development process. Our group has recently evaluated two formulation development processes where high-throughput technology can benefit. We developed a new automation-assisted formulation preparation method for large screens such as DOE type of studies. This method allows us to rapidly prepare a large number of formulations with up to 95% less raw material (buffer). To further streamline and reduce the manual operations involved in the formulation development process, we searched for miniaturized containers for conducting protein stability studies. We evaluated different types of glass and plastic vials with the standard 2CC glass vials. However, there is a significant difference between the standard 2CC glass vial and other glass and plastic vials in terms of protein oxidation under thermal stressed condition. Overall, there are both opportunities and challenges for using high-throughput technology in the area of protein formulation development.

11:00am - 11:30am 30 mins
Cell Culture & Upstream Processing
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
  • Ru Zang - Director, Momenta Pharmaceuticals
more
11:00am - 11:30am 30 mins
Recovery & Purification
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
  • Ru Zang - Director, Momenta Pharmaceuticals
more
11:00am - 11:30am 30 mins
Analytical & Quality
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
  • Ru Zang - Director, Momenta Pharmaceuticals
more
11:00am - 11:30am 30 mins
Speed from Gene to Market
Experiences and Challenges during the Commercialization of a Monoclonal Antibody
  • Jeffrey Ly - Associate Principal Scientist, Merck
more

A variety of scientific and regulatory challenges may be encountered during the commercialization of a monoclonal antibody. In this work, we present case studies detailing a series of experiences and lessons learned during this process. The work will cover topics including qualification of scale-down models, troubleshooting scale-up and tech transfer, mitigation strategies for process performance variability, and confirmation of clonality. A variety of experimental and statistical methodologies were implemented to address these concerns, including application of multivariate data analysis. Details of the methodologies will also be provided to demonstrate their application to troubleshooting of commercial upstream fed-batch production processes.

11:00am - 11:30am 30 mins
Manufacturing Strategy
Experiences and Challenges during the Commercialization of a Monoclonal Antibody
  • Jeffrey Ly - Associate Principal Scientist, Merck
more

A variety of scientific and regulatory challenges may be encountered during the commercialization of a monoclonal antibody. In this work, we present case studies detailing a series of experiences and lessons learned during this process. The work will cover topics including qualification of scale-down models, troubleshooting scale-up and tech transfer, mitigation strategies for process performance variability, and confirmation of clonality. A variety of experimental and statistical methodologies were implemented to address these concerns, including application of multivariate data analysis. Details of the methodologies will also be provided to demonstrate their application to troubleshooting of commercial upstream fed-batch production processes.

11:15am - 11:40am 25 mins
Drug Product, Fill-Finish & Formulations
Application of Submicron Particle Tracking Technique in Characterizing Aggregation and Particle Formation during Product Development
  • Stanley Kwok, PhD - Scientist, Seattle Genetics
more

Aggregate/subvisible particles are critical quality attributes that are carefully studied during drug development due to their possible linkage to immunogenicity. Here we present the implementation of submicron particle tracking technology during antibody drug conjugates (ADCs) development. The submicron particle tracking flow microscopy method provides a quantitative profile of subvisible particulates in the 50-1000nm range (mAbs and ADCs). The obtained particle distribution/count data from different stressed studies provide potential mechanistic insight of aggregate behavior in the submicron characterization gap.

11:30am - 12:00pm 30 mins
Cell Culture & Upstream Processing
Full-Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
more
11:30am - 12:00pm 30 mins
Recovery & Purification
Full-Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
more
11:30am - 12:00pm 30 mins
Analytical & Quality
Full-Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
more
11:30am - 12:00pm 30 mins
Speed from Gene to Market
PANEL DISCUSSION: Balancing Speed and Risk in Manufacturing
  • Pranhitha Reddy, Ph.D. - Founder, Gene to BLA Consulting
more
11:30am - 12:00pm 30 mins
Manufacturing Strategy
PANEL DISCUSSION: Balancing Speed and Risk in Manufacturing
  • Pranhitha Reddy, Ph.D. - Founder, Gene to BLA Consulting
more
11:40am - 12:00pm 20 mins
Drug Product, Fill-Finish & Formulations
Potential Impact of Nano Particulate Impurities from Sugars on Therapeutic Proteins
  • Anant Sharma - Formulation Scientist, Eli Lilly & Co.
more
12:05pm - 12:35pm 30 mins
Workshop
Technology Workshop 1
more
12:05pm - 12:35pm 30 mins
Workshop 2
Technology Workshop 2
more
12:05pm - 12:35pm 30 mins
Workshop 3
Screening and Characterization of Clones in Days instead of Months
  • Anupam Singhal, PhD - Sr. Manager, Technology Development, Berkeley Lights, Inc.
more
12:05pm - 12:35pm 30 mins
Workshop 4
Technology Workshop 4
more
12:05pm - 12:35pm 30 mins
Workshop 5
High Throughput Data Driven Process Development
more

Part 1:

Development of ‘ambr 250 perfusion’ – A Novel Automated Single-Use Perfusion Mini-Bioreactor 

In recent years a strong trend towards continuous processing has gathered momentum, driven by the promise of process intensification, reduced cost of goods, and more consistent and better controlled product quality. Benchtop bioreactors provide a route to developing this new wave of intensified/continuous cell culture processes. However this approach is manually intensive, relatively low throughput and cost-intensive to operate. The ambr bioreactor systems have been widely implemented as a high-throughput approach to screening and process development of fed-batch cultures. The ambr product line is expanding to include ambr 250 perfusion, which enables up to 24 single-use perfusion cultures to be carried out simultaneously under fully automated control. The ambr 250p reduces the complexity and expense associated with medium to large scale perfusion culture systems and makes optimization experiments involving DOE approaches more straightforward to complete. This workshop will highlight the key features of this novel system and showcase case studies that show system robustness and capability of reaching culture densities greater than 100 million cells/mL. Lastly, data will be presented showing the capability of this system to be used for both traditional perfusion processes as well as intensified fed-batch cultures.


Part 2:

Gain manufacturability information for downstream processing already during your candidate selection

Manufacturability becomes more important in recent years as streamlining the process development is the only area where time to market can be optimized. Challenges like e.g. tendency to aggregate etc. of the selected candidate during the development of the downstream process can be time consuming especially during scale-up to secure a highly productive commercial manufacturing process.The ability to study some of this properties during the candidate selection will make the process development more predictive.ambr crossflow is a screening tool developed exactly for this purpose combined with early stage characterization and optimization.Minimal volume requirements provide the base to study the behavior of your candidate in multi-parallel experiments.Identifying the behavior under stress conditions like cross flow operations, different buffer condition, high concentrations and formulation will support decisions in the downstream development.In this technical presentation the working principles of the multi-parallel system and examples from real product condition will be presented.

12:05pm - 12:35pm 30 mins
Workshop 6
Optimizing reliability, quality and ease-of-use with a new generation of 2D-style BioProcess Containers
  • Jarv Campbell, BS, MBA-IM - Senior Global Product Manager, Thermo Fisher Scientific
more

Thermo Fisher Scientific introduces the next generation of its 2D-style BioProcess Containers (BPC). The Labtainer Pro BPC is the culmination of our years of experience with single-use consumables, designed to optimize reliability, quality and ease-of-use. Please join us as we present these enhancements and provide a unique hands-on experience of our Labtainer Pro BPC.

12:35pm - 1:40pm 65 mins
Networking Luncheon in the Poster & Exhibit Hall
1:40pm - 1:45pm 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Mark Yang, PhD - Director, Global Pharmaceutical Development Biologics, Sanofi
more
1:40pm - 1:45pm 5 mins
Analytical & Quality
Chairperson's Remarks
  • Melissa Morandi - Vice President, Global Quality, Aegerion Pharmaceuticals
more
1:40pm - 1:45pm 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Gene Lee, PhD - Senior Director and US Site Head, DDTechnologies, Head, Protein & Cell Sceiences/NBE, EMD Serono
more
1:40pm - 2:00pm 20 mins
Novel Technology Showcase - Disruptive Downstream Technologies
Chairperson's Remarks
1:40pm - 1:45pm 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Stephanie Rieder, PhD - Principal Research Scientist, Process Sciences, AbbVie Bioresearch Center
more
1:40pm - 1:45pm 5 mins
Recovery & Purification
Chairperson's Remarks
  • Abhinav Shukla, PhD - Senior Vice President, KBI Biopharma Inc.
more
1:40pm - 1:45pm 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Jeffrey Johnson - New Technology Lead and Director, Merck & Co., Inc.
more
1:45pm - 2:15pm 30 mins
Drug Product, Fill-Finish & Formulations
Single-Use Technologies in Fill-Finish Manufacturing
  • Jeremy Guo, PhD - Fellow, Regeneron
more

Single Use Technology has increasingly become a dominant strategy in fill/finish with noted benefits in cost saving and flexibility. There are a variety of vendors carrying hundreds of brands catering to a number of cost-sensitive CMOs and a comprehensive evaluation is recommended for innovators to select the correct system for validation and commercial manufacturing.

1:45pm - 2:15pm 30 mins
Analytical & Quality
Investigation of Fc Receptor Binding and Pharmacokinetics of Distinct Fc Glycans
  • Marco Thomann - Senior Scientist, Roche Diagnostics GmbH
more

Glycosylation of therapeutic proteins is of importance since it can significantly impact biological properties. Glycosylation is heterogeneous and can be subject to batch-to-batch variability. There are a variety of possibilities to influence and investigate glycosylation. In this talk, the in vitro glycoengineering (IVGE) approach will be very briefly introduced and case studies with new data will be presented, including investigation of glyco-modified antibodies incl. changes in galactosylation and sialylation and its impact on Fcy receptor binding and ADCC activity. Furthermore, new results of a recent study on the impact of certain glycan species on animal PK will be shown.

1:45pm - 2:15pm 30 mins
Speed from Gene to Market
Simultaneous CHO Cell Clone Selection and Process Development in a Tight Timeline
  • Christopher Miller, MS - Senior Scientist, KBI Biopharma
more
1:45pm - 2:15pm 30 mins
Cell Culture & Upstream Processing
High Density CHO Perfusion Cultures - Compare the Performance, Highlight the Differences, and Discuss the Challenges Observed when Developing N-1 Perfusion Processes Across Different CHO Cell Lines
  • Caitlin Kurtz - Engineer I, Biogen
more
1:45pm - 2:15pm 30 mins
Recovery & Purification
Viral Vaccine Process Intensification Challenges and How to Overcome Them
  • Paul Ko - Senior Scientist, Cell Technologies , Janssen Research & Development
more
1:45pm - 2:15pm 30 mins
Manufacturing Strategy
Why Hasn’t the Promise of Single Use Implementation in Commercial Manufacturing Been Fulfilled and what are we doing about the Barriers and Risks?
  • Derek Willson-Parry - Drug Substance Phorum Lead, BioPhorum Operations Group
more

The promise of Single Use has been realized in process development and clinical manufacturing but less so in commercial manufacturing. Barriers and risks include: Extractables and Leachables; Supplier Changes; Supply Base Reliability; Inconsistent User Requirement Specifications; Inconsistent Testing, Validation, and Quality Release Practices; Supplier Management; and lack of Design Harmonization. The BPOG Disposables Program has developed teams to address each of these risks, and in strong collaboration between biomanufacturers and suppliers is making strong progress towards implementing best practice guidelines on each.

2:00pm - 2:20pm 20 mins
Novel Technology Showcase - Disruptive Downstream Technologies
TBA
2:15pm - 2:45pm 30 mins
Drug Product, Fill-Finish & Formulations
Impact of Closed System Transfer Devices to Drug Product Quality: The Importance of Compatibility Testing
  • Frankie Petoskey - Senior Research Associate, Seattle Genetics
more

Closed System Transfer Devices (CSTDs) present an additional hurdle for the administration of ADCs. A compatibility evaluation of six FDA-approved CSTD devices with reconstituted lyophilized ADC was performed, evaluating physical compatibility to the drug product configuration and administrative route and product quality attributes such as aggregation, charge variants, visible particles, and subvisible particles. Results showed the application of some CSTDs could affect product quality of the drug product, and highlights the importance of compatibility testing these devices.


2:15pm - 2:45pm 30 mins
Analytical & Quality
A Fully Integrated Data Management Platform for Biotherapeutic Analytics to Enhance Data Access and Utilization
  • John Lin - Associate Director, Systems Engineering, Five Prime Therapeutics
more

Timely delivery of and access to key analytics and characterization data during biotherapeutic development and manufacturing is crucial for informed decision making and resource optimization. At Five Prime Therapeutics, we have developed an integrated data management platform to systematically capture, track, and report analytical and stability study data from both internal and external sources. In house result integration leverages direct interface with instrument and sample prep platform. For outsourced studies, we work closely with our contract manufacturing organizations to standardize and streamline data transfer and intake on a systematic basis. To provide access to real time data, we create interactive dashboard that enables both individual sample profiling, as well as aggregated global analysis across processes and products. Case study will be presented to highlight end-to-end data workflow for an automated, high throughput analytical assay. Fully integrated sample registration, barcode tracking, liquid handler worklist, and instrument readout allow data to be collected and published to the data warehouse seamlessly with no manual user entries, thus increasing operational efficiency and ensuring data integrity.

2:15pm - 2:45pm 30 mins
Speed from Gene to Market
Overcoming Challenges for Developing a Platform Process for Early Phase ADC Manufacturing Under Tight Timelines
  • Chi Zhang, PhD - Scientist, Ambrx, Inc.
more
2:15pm - 2:40pm 25 mins
Cell Culture & Upstream Processing
Antibody Reduction and Mitigation for a Novel Antibody
  • Meimei Liu - Scientist, Upstream Development and Operations, Teva Pharmaceuticals
more
2:15pm - 2:45pm 30 mins
Recovery & Purification
Handling High Titer Processes and Strategies for DSP Facility Fit
  • Christopher Miller, MS - Senior Scientist, KBI Biopharma
more
2:15pm - 2:45pm 30 mins
Manufacturing Strategy
Evaluation of Upstream and Downstream Process Methods utilizing Single-Use Technologies
  • Adam Goldstein, M.S. - Principle Scientist, Genentech, Inc.
more

This presentation will discuss: 1) Which technologies hold strong ROI value benefiting manufacturing, tech transfer and new production introductions? 2) Review of disposables available in US and DS processing 3) Comparing the use of fixed stainless steel technologies in reference to the emerging use of disposables in US + DS processing 4) Evaluating the long-term consequences associated with the introduction of SUS in terms of recurring costs and sustainability and 5) Challenges of single use implementation in a commercial environment.

2:20pm - 2:40pm 20 mins
Novel Technology Showcase - Disruptive Downstream Technologies
TBA
2:45pm - 3:15pm 30 mins
Presentation 1
Concurrent Scientific & Technology Presentations 1
more
2:45pm - 3:15pm 30 mins
Presentations 2
The Transformation to Excellence - How to Leverage Lean Principles to Improve Single-Use Assembly Product Quality and Supply Security
  • William Faria - Head of Danvers Operations Sara Bell, Senior Marketing Manager, Single-Use Solutions, Millipore Sigma
  • Sara Bell - Senior Marketing Manager, Single Use, MilliporeSigma
more

Biosimiliars, emerging markets, novel therapies and next generation processing are just a few of the variables affecting the biopharma industry and driving the adoption of single-use technologies. As the usage of single-use technologies increases, suppliers need to continuously improve to meet the stringent requirements of their drug manufacturer customers, as well as ensure capacity to keep pace with single-use growth. From the modification of shift structures to implementing Poka Yoke principles, this presentation will demonstrate how a customer focused mission to boost single-use assembly product quality and supply security, led to a true Center of Excellence, with a more empowered and engaged workforce, increased manufacturing efficiency, improved capacity and a new operational model.

2:45pm - 3:15pm 30 mins
Presentations 3
Concurrent Scientific & Technology Presentations 3
more
2:45pm - 3:15pm 30 mins
Presentations 4
Concurrent Scientific & Technology Presentations 4
more
2:45pm - 3:15pm 30 mins
Presentations 5
Concurrent Scientific & Technology Presentations 5
more
3:15pm - 4:00pm 45 mins
Networking Refreshment Break in the Poster & Exhibit Hall
4:00pm - 4:25pm 25 mins
Cell Culture & Upstream Processing
Development of a Clone Selection and Media Optimization Strategy to Convert a Roller Bottle Process to a Suspension Bioreactor Process
  • Pubali Banerjee, PhD - Senior Upstream Development Engineer, Shire LLC
more
4:00pm - 4:25pm 25 mins
Recovery & Purification
Streamlining Process Validation through Prior Knowledge: A Case Study in Buffer & Process Solution Chemical Stability & Hold Times
  • James Patch, Ph.D. - Senior Engineer, Genentech, Inc.
more
4:00pm - 4:25pm 25 mins
Manufacturing Strategy
Single Use Systems: Challenges to Implementation and How to Overcome Them
  • Gregory Naugle, MSc. - Executive Director, Merck
more

Single use systems in biopharmaceutical manufacturing processes are becoming increasingly prevalent and offer a variety of advantages throughout the product lifecycle. However deployment of these technologies can present a variety of operational and logistical challenges. This talk will discuss some of these challenges and how to address them prospectively and throughout the commercialization process.

4:00pm - 4:30pm 30 mins
Analytical & Quality
Analytical Characterization Strategy utilizing Mass Spectrometry for Construct Screening at Early Stage to Minimize Potential CMC Challenges
  • Gary Li, PhD - Principal Scientist, Aptevo Therapeutics
more

LC-MS is a powerful protein characterization tool that can be used to identify post-translational modifications (PTMs) on proteins during the clone selection process. An early read on product quality during clone selection can help avoid CMC pitfalls that can result in costly delays. PTMs can be sequence-dependent and by identifying these PTMs during the sequence optimization stage, enables the selection of constructs with more desirable product quality attributes. Four examples will be shown that highlight the use of mass spectrometry to confirm the presence of expected PTMs such as N-glycosylation of the Fc region in mAb-like molecules, as well as to screen out undesirable PTMs such as proline hydroxylation. These case studies demonstrate that in-depth characterization using mass spectrometry early in the development process can mitigate potential CMC risks and enable the product development and IND timelines to stay on track. 1. Identification of N-terminal pyroglutamate formation – an expected PTM 2. Cleavage site identification to minimize cleavages and increase protein yield 3. Proline hydroxylation PTM – an undesirable PTM 4. O-glycan PTM identification — selecting constructs with low levels of O-glycosylation for reducing manufacturing risk

4:00pm - 4:30pm 30 mins
Speed from Gene to Market
Analytical Characterization Strategy utilizing Mass Spectrometry for Construct Screening at Early Stage to Minimize Potential CMC Challenges
  • Gary Li, PhD - Principal Scientist, Aptevo Therapeutics
more

LC-MS is a powerful protein characterization tool that can be used to identify post-translational modifications (PTMs) on proteins during the clone selection process. An early read on product quality during clone selection can help avoid CMC pitfalls that can result in costly delays. PTMs can be sequence-dependent and by identifying these PTMs during the sequence optimization stage, enables the selection of constructs with more desirable product quality attributes. Four examples will be shown that highlight the use of mass spectrometry to confirm the presence of expected PTMs such as N-glycosylation of the Fc region in mAb-like molecules, as well as to screen out undesirable PTMs such as proline hydroxylation. These case studies demonstrate that in-depth characterization using mass spectrometry early in the development process can mitigate potential CMC risks and enable the product development and IND timelines to stay on track. 1. Identification of N-terminal pyroglutamate formation – an expected PTM 2. Cleavage site identification to minimize cleavages and increase protein yield 3. Proline hydroxylation PTM – an undesirable PTM 4. O-glycan PTM identification — selecting constructs with low levels of O-glycosylation for reducing manufacturing risk

4:00pm - 4:25pm 25 mins
Drug Product, Fill-Finish & Formulations
New Innovations in Fill/Finish and Drug Product Manufacturing
  • Mark Yang, PhD - Director, Global Pharmaceutical Development Biologics, Sanofi
more

Significant progress has been made in biopharmaceutical fill finish processes in the past a few years. This presentation will highlight and review the major advancement in these field, including new formulation strategies, novel container/closure system, (gloveless) isolator, single-use components, multi-format flexible fillers, new lyophilization and drying technologies, in-line process monitoring, and new product inspection equipment.

4:25pm - 4:50pm 25 mins
Cell Culture & Upstream Processing
Increased MSX Level Altered CHO Cell Metabolism and Improved Productivity and Production Stability: A Strategy for Industrial Bioprocessing Yield Improvement
  • Jun Tian, PhD - Senior Scientist, Bristol-Myers Squibb
more
4:25pm - 4:50pm 25 mins
Recovery & Purification
Factors Contributing to Filter Plugging – Harvest Filterability Model Development
  • Anna Senczuk, MSc - Senior Process Engineer II, Shire
more
4:25pm - 4:50pm 25 mins
Manufacturing Strategy
Practical Experience with Single-Use Technologies in Commercial Manufacturing: What End-users Should Consider
  • Andre Pastor, PhD - Technology Expert, Engineering & Technology, Bayer AG
more
4:25pm - 4:50pm 25 mins
Drug Product, Fill-Finish & Formulations
Case Study: Filling in Vapor Phase Hydrogen Peroxide (VPHP)-Sanitized Isolator – VPHP Uptake and Impact on Monoclonal Antibody (mAb) Drug Product Quality
  • Yuh-Fun Maa, PhD - Senior Principal Engineer, Genentech
more

A mAb drug product was transferred to a manufacturing site with a VPHP-decontaminated isolator filling core. Under the quality-by-design risk tool, a combination of small-scale and manufacturing-scale studies was performed to evaluate how key process parameters affected hydrogen peroxide uptake behaviors. This study justified the setting of process parameter acceptable ranges that mitigated the risk on product quality under the worst-case scenario.

4:30pm - 4:50pm 20 mins
Analytical & Quality
Rapid PC Studies Methodology, PC Data Package in 6 Months
  • Shahid Rameez, Ph.D. - Principal Scientist, Process Development, KBI Biopharma Inc.
more
4:30pm - 4:50pm 20 mins
Speed from Gene to Market
Navigating a Streamlined Path to IND
4:50pm - 5:15pm 25 mins
Cell Culture & Upstream Processing
Monoclonal Antibody Disulfide Bond Reduction and Re-Oxidation by Copper Sulfate During Manufacturing and Impact on Product Quality
  • Green Zhang, PhD - Associate Director, Large Molecule Purification, Incyte Corporation
more
4:50pm - 5:15pm 25 mins
Recovery & Purification
Digital Tools Leverage Research Knowledge for De Novo Downstream Process Design
  • Rushd Khalaf, PhD - PostDoc, Novartis Pharma
more
4:50pm - 5:15pm 25 mins
Manufacturing Strategy
Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network – Preparing for Commercial Production
  • Lance Marquardt - Manager, Upstream Processing, Bristol-Myers Squibb
more

An overview of the current use of single use manufacturing within the Bristol-Myers Squibb manufacturing networks and planned future state.  The challenges in implementing single use manufacturing for commercial production will be discussed.  Comparisons will be made to the implementation of past improvements and the plans for future improvements, such as continuous processing.

4:50pm - 5:15pm 25 mins
Analytical & Quality
A Layered Approach to Early Process Development – Strategies for a Non-Platform Antibody
  • Abraham Friedman, PhD - Early Stage Process Development, Alexion Pharmaceuticals, Inc.
more
4:50pm - 5:15pm 25 mins
Speed from Gene to Market
A Layered Approach to Early Process Development – Strategies for a Non-Platform Antibody
  • Abraham Friedman, PhD - Early Stage Process Development, Alexion Pharmaceuticals, Inc.
more
4:50pm - 5:15pm 25 mins
Drug Product, Fill-Finish & Formulations
Drug Product Control Strategy for Prefilled Syringes to Ensure Sterility Assurance Post Air Shipment
  • Kala Chandramouli - Head, Manufacturing Sciences and Technology – Biosimilar Mabs, Biocon
more

During air shipment of Prefilled syringes, the low pressure encountered in the cargo hold cause stopper movement. This movement can in turn impact sterility of the finished product. Process development should aim at identifying process parameters to define permissible stopper movement. In this topic, we will discuss manufacturing controls established for pre filled syringe to accommodate air shipment.

5:15pm - 5:40pm 25 mins
Cell Culture & Upstream Processing
Maintaining Product Quality from Early to Late Stage Process Development
  • Jason Goodrick - Senior Engineer, Late Stage Cell Culture, Genentech, Inc.
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5:15pm - 5:40pm 25 mins
Recovery & Purification
Managing Process Characterization and Validation on a Breakthrough Therapy Program
  • Michael Glacken, Ph.D. - Senior Consultant, BioProcess Technology Consultants, Inc.
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5:15pm - 5:40pm 25 mins
Manufacturing Strategy
How SUBs and SUMs can be QC Micro and EHS’s Best Friends
  • Katherine Leitch - Director of Technical Services, Alexion
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Single-use Bioreactors (SUBs) and Single-use Mixers (SUMs) offer significant advantages for bioburden control and reduced hazards from an Environmental, Health, and Safety (EHS) perspective. This presentation will explore Alexion’s experiences with single-use technology in external manufacturing and as part of an on-going capital project at Alexion Athlone Manufacturing Facility.

5:15pm - 5:40pm 25 mins
Analytical & Quality
Achieving the Industry’s Shortest Timelines to IND
5:15pm - 5:40pm 25 mins
Speed from Gene to Market
Achieving the Industry’s Shortest Timelines to IND
5:15pm - 5:40pm 25 mins
Drug Product, Fill-Finish & Formulations
Lipid Nanoparticle Lyophilization and Manufacturing: Challenges and Opportunities
  • Bingquan (Stuart) Wang, PhD - Director, Moderna Therapeutics
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Liposomes have been widely used as drug delivery systems for different therapeutics. However, its application is still challenging due to its physical and chemical instabilities in aqueous dispersion. The challenges in the development of stable lipid nanoparticles(LNP) and manufacturing of lyophilized LNP-based drug product will be covered, and the solutions to overcome these barriers will be discussed.

5:40pm - 5:45pm 5 mins
Close of Day