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Key Sessions

Natraj Ram, Ph.D.

Keynote Address: Mission Possible – Democratizing Technology Access for Biomanufacturing

Alkermes

Jorg Thommes, PhD

Keynote Address – CMC at the Bill & Melinda Gates Medical Research Institute: Cost to Serve Drives Manufacturing and Supply

Bill & Melinda Gates Medical Research Institute

7:00am - 8:00am

Registration and Breakfast

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8:00am - 8:15am

Chairperson’s Opening Remarks

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Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
4:40pm - 5:25pm

Networking Refreshment Break and Grand Opening of the Poster & Exhibit Hall

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Showing of Streams
6:40pm - 8:40pm

Networking Cocktail Reception in the Poster & Exhibit Hall

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7:00am - 8:00am 60 mins
Registration and Breakfast
8:00am - 8:15am 15 mins
Chairperson’s Opening Remarks
8:15am - 9:00am 45 mins
Opening Plenary Session: Collaborative Strategies for Future Success
Keynote Address: Mission Possible – Democratizing Technology Access for Biomanufacturing
  • Speaker Natraj Ram, Ph.D. - Senior Director, Biologics Process Development, Alkermes
9:00am - 9:45am 45 mins
Info
Opening Plenary Session: Collaborative Strategies for Future Success
Plenary Panel Discussion - Together We Win! Building a Collaborative and Sustainable Strategy for Success in the Future
  • Moderator: Natraj Ram, Ph.D. - Senior Director, Biologics Process Development, Alkermes

This timely discussion will focus on the progress and expansion of collaborate efforts helping to break down the walls between functional groups, companies, academia, vendors, and other industries. Our panel of experts, representing academia, industry, suppliers and industry consortium, will discuss what’s needed to execute an open source development paradigm, establish common practices and standards, and share case studies and lessons learned from their recent efforts.

9:45am - 10:15am 30 mins
Info
Spotlight Presentation 1
Sponsored Breakfast Presentations - Bio-Rad Laboratories
9:45am - 10:15am 30 mins
Info
Spotlight Presentation 2
New membrane platform enables highly productive Rapid Cycling Chromatography for mAb capture
  • Ricarda Busse - Product Manager Membrane Chromatography | Separation Technologies, Sartorius Stedim Biotech GmbH

Limitations in productivity frequently lead monoclonal antibody (mAb) capture by protein A resins to be described as a bottleneck in downstream processing. Recent developments such as simulated moving bed or multi column chromatography drive the industry towards complex solutions with enhanced risks but only limited productivity gains.

Rapid Cycling Chromatography (RCC) based on high capacity membranes will be a game changer in DSP. With 15 fold higher productivity, one can choose between faster processing and membrane write-off per batch. RCC eliminates bioburden risk caused by resin reuse, and opens the way for truly disposable, column-free chromatography.

Sartorius Stedim Biotech has developed a new membrane platform featuring high capacity mAb processing and including RCC-system technology. The new protein A membrane and chromatography system with intelligent data analytics (based on Umetrics) offers the biopharma industry simplification and processing flexibility.

10:15am - 10:45am 30 mins
Info
Cell Culture & Upstream Processing
Effective Temperature Shift Method Development for Optimization of Productivity and Protein Quality in CHO Cell Culture Manufacturing
  • Kyle McHugh - Scientist, Bristol-Myers Squibb

Temperature shifts to lower culture temperatures are frequently employed in protein therapeutic manufacturing for improvement of productivity or altering protein quality. The effect of a temperature shift may vary depending on the expression host and characteristics of the expressed protein. We demonstrate here a systematic approach to identify temperature shift parameters to optimize productivity and quality for efficient and confident translation to large-scale production.

10:15am - 10:45am 30 mins
Speed from Gene to Market
Accelerating Upstream Process Development to First in Human Products
  • Anurag Khetan - Site Director, Biologics Process Development, Bristol-Myers Squibb
10:15am - 10:45am 30 mins
Info
Recovery & Purification
New Ways of Running Perfusion for Next Generation Manufacturing

A Representative from Pfizer

10:15am - 10:45am 30 mins
Info
Intensified and Continuous Processing
New Ways of Running Perfusion for Next Generation Manufacturing
  • Matthew Gagnon - Scientist, Process Engineer III, Pfizer

A Representative from Pfizer

10:15am - 10:45am 30 mins
Info
Manufacturing Strategy
How to Handle a Simultaneous Switch in Process and Single Use Platform Technology
  • Dave Lam - Manufacturing Technical Specialist, Genetech

With the advent of biosimilars in the biologics industry, BioPharma companies have been searching for ways to increase process efficiency by introducing new modes of operations and implementing technologies that reduce overall cost of manufacturing. This case study focuses on the approach taken within process development for a simultaneous shift in process from fed-batch to perfusion mode along with a change in process technology platform for bioreactors. Key elements for the deployment of this approach required careful review of risks, diligent evaluation of equipment and process as well as an assessment for feasibility of global harmonization across different sites.

10:15am - 10:45am 30 mins
Info
Analytical & Quality
Risk-Based Assessment of CQAs for Bispecific molecules
  • Dana Filoti - Senior Scientist, Abbvie

The DVD-Ig format is one of the many bispecific biologic formats, where challenging developability profile is dictated by the structure-function symbiosis. This presentation will discuss the lessons learned from developing the DVD-Ig bispecific platform by presenting cumulative analytical observations gathered from characterizing a panel of DVD-Igs alongside their parent mAbs.

10:45am - 11:15am 30 mins
Info
Cell Culture & Upstream Processing
Cell Culture Process Optimization For A Late Stage Monoclonal Antibody Program
  • Balrina Malik Gupta - Associate Principal Scientist, Merck & Co

Starting with an un-optimized process for an early stage Mab program, process improvements were investigated to improve productivity, robustness and meet quality criteria. First, media screening studies using a few commercial formulations yielded a media/feed combination that gave almost 3X increase in titer. N-1 conditions were studied to get high cell density using a batch process. The process was scaled up successfully from ambr® 250 to 2000L scale.

10:45am - 11:15am 30 mins
Speed from Gene to Market
Case Study for Developability Assessment of Three Therapeutic Antibodies
  • Zhiping Yao, Ph.D. - Director, Process Science, JOINN Biologics US Inc
10:45am - 11:15am 30 mins
Recovery & Purification
Robust N-1 Perfusion Process Development for Intensified Fed-Batch Processes: Achieving Consistent N-1 Growth to Target High Cell Density Inoculation
  • Charles Hill - Associate Engineer/Scientist, Bristol-Myers Squibb
10:45am - 11:15am 30 mins
Intensified and Continuous Processing
Robust N-1 Perfusion Process Development for Intensified Fed-Batch Processes: Achieving Consistent N-1 Growth to Target High Cell Density Inoculation
  • Charles Hill - Associate Engineer/Scientist, Bristol-Myers Squibb
10:45am - 11:15am 30 mins
Info
Manufacturing Strategy
Building Strategic Plans for Single Use Technologies to Insure Ramp-Up to Full Commercial Routine Operations
  • Bruno Tricoire - Head of Tech Transfers and leader of the Sanofi Single Use Network, Sanofi Pasteur

As SUT based processes are entering routine commercial manufacturing, the biopharmaceutical industry needs compliant, cost effective, and robust supply of Single Use Systems. Standardization is in everybody’s mind, but is a difficult target and will definitely be a long journey. Meanwhile, building a strategic plan for SUT, from the early stage of clinical development, involving SMEs, development teams, process engineers, manufacturing, quality, procurement, supply chain is the key to successful project execution and to risk prevention in further operations within each biopharmaceutical company. Also, the benefits from harmonization as an industry through the BPOG roadmap will be discussed.

10:45am - 11:15am 30 mins
Info
Analytical & Quality
Applying Glyco-Analytics For New Fusion Proteins
  • Joseph Zaia - Professor of Biochemistry, Boston University

Antibody effector functions depend on glycosylation of the Fc domain. Because the biosynthetic reactions in the endoplasmic reticulum and Golgi apparatus do not go to completion, glycosylation at a given protein site is a mix of variants. This glyco-heterogeneity poses challenges to the analysis of new antibody-based biologic drugs because it is generally not possible to make a product that has a single homogeneous glycosylation structure. Rather, it is necessary to characterize the distribution of glycoforms at each protein site for use as evidence to support a risk-based approach that includes molecular complexity.

11:15am - 11:45am 30 mins
Cell Culture & Upstream Processing
Cell Culture Media Characterization Strategy for Commercial Manufacturing
  • Min Zhang - Director, Manufacturing Sciences and Technology (Upstream), AstraZeneca
11:15am - 11:45am 30 mins
Speed from Gene to Market
From Sequence to Product in Hours – Cell Free Expression for Next-Generation Therapeutics
  • Philip Probert, PhD - Senior Upstream Scientist, CPI Biologics
11:15am - 11:45am 30 mins
Recovery & Purification
Scale-Up Design and Optimization for a Semi-Continuous Downstream Process
  • James Angelo, Ph.D. - Scientist, Bristol-Myers Squibb
11:15am - 11:45am 30 mins
Intensified and Continuous Processing
Scale-Up Design and Optimization for a Semi-Continuous Downstream Process
  • James Angelo, Ph.D. - Scientist, Bristol-Myers Squibb
11:15am - 11:45am 30 mins
Manufacturing Strategy
Integrating Single Use Systems into Plant Automation and Digitalisation
  • Hana Sheikh - MSAT Engineer II, Genentech
11:15am - 11:45am 30 mins
Info
Analytical & Quality
Detailed Structural Understanding of A Unique Non-Covalent Protein Hetero-Dimer Enables Rational Process Control Decisions
  • Chris Barton - Head of US Characterization, Takeda

We describe how advanced characterization approaches can be used to understand a non-covalent hetero-dimeric complex, including the mechanism of protein binding, the nature of protein mis-pairing variants and the underlying protein structures required for establishing binding interfaces. These studies provided information and tools for a rationale process control strategy based on product and process understanding.

11:50am - 12:20pm 30 mins
Info
Tech Workshop 1
Avantor Technology Workshop
11:50am - 12:20pm 30 mins
Info
Tech Workshop 2
Avid Bioservices Techonology Workshop
11:50am - 12:20pm 30 mins
Info
Tech Workshop 3
FUJIFILM Technology Workshop
11:50am - 12:20pm 30 mins
Info
Tech Workshop 4
Syngene International Technology Workshop
11:50am - 12:20pm 30 mins
Info
Tech Workshop 5
Tecan Technology Workshop
1:30pm - 2:00pm 30 mins
Cell Culture & Upstream Processing
Developing a Chemically-Defined Basal Medium for Fed-Batch Production of mAbs
  • Zhongqiang Wang - Research Scientist, Gilead Sciences
1:30pm - 2:00pm 30 mins
Recovery & Purification
KEYNOTE ADDRESS: Strategies for Efficiency and Optimization
  • Ciaran Brady, Ph.D. - Executive Director, Manufacturing Science and Technology - Drug Substance, Bristol-Myers Squibb
1:30pm - 2:00pm 30 mins
Intensified and Continuous Processing
Application of Continuous Manufacturing for Viral Vaccines
  • Rahul Singhvi, ScD - Chief Operating Officer, Takeda Vaccines, Inc.
1:30pm - 2:00pm 30 mins
Manufacturing Strategy
KEYNOTE ADDRESS: Strategies for Efficiency and Optimization
  • Ciaran Brady, Ph.D. - Executive Director, Manufacturing Science and Technology - Drug Substance, Bristol-Myers Squibb
1:30pm - 2:00pm 30 mins
Info
Analytical & Quality
Leveraging High-Dimensional ‘-Omics’ Technologies for Comprehensive Profiling of CAR T Cells to Resolve Drug Product Complexity
  • Eric Alonzo - Scientist, Cellular Analytics, Bluebird Bio

Clinical-grade CAR T cell drug products contain a heterogenous mixture of phenotypically and functionally distinct cells. Such heterogeneity necessitates innovative and comprehensive strategies to characterize CAR T cell therapy investigational drug products. A case study will be presented to demonstrate how high dimensional ‘-omics’ is used in CAR T manufacturing and beyond to resolve drug product complexity and identify potentially key clinical correlates.

2:00pm - 2:30pm 30 mins
Cell Culture & Upstream Processing
Novel Additives that Modulate High Mannose N-linked Glycosylation in Monoclonal Antibodies Produced in CHO Cells
  • Tim Brantley - Engineer II Cell Culture Development, Biogen
2:00pm - 2:30pm 30 mins
Speed from Gene to Market
In-silico CMC Development: A Bottom-Up Approach
  • Lars Pampel, Ph.D - Head, Process Sciences, Novartis
2:00pm - 2:30pm 30 mins
Recovery & Purification
Super-Batch Chromatography: Enhancing Downstream Productivity Using an Existing Facility and Equipment through Rapid Cycling of Short Columns
  • Dharmesh Kanani, Ph.D. - Senior Scientist, Group Lead, Teva Pharmaceuticals, Inc.
2:00pm - 2:30pm 30 mins
Intensified and Continuous Processing
Process Intensification/Continuous Manufacturing of Oligos and Peptides
  • Kris Ruanjaikaen, Ph.D. - Senior Engineer, Technical Development, Biogen
2:00pm - 2:30pm 30 mins
Manufacturing Strategy
Super-Batch Chromatography: Enhancing Downstream Productivity Using an Existing Facility and Equipment through Rapid Cycling of Short Columns
  • Dharmesh Kanani, Ph.D. - Senior Scientist, Group Lead, Teva Pharmaceuticals, Inc.
2:00pm - 2:30pm 30 mins
Info
Analytical & Quality
Titer and Yield Determination in Bioprocessing: A Comparison of Techniques
  • Xiaoyang Zheng - Associate Director, Takeda

During biopharmaceutical development, titer and yield are very important measures of the efficiency of a manufacturing process and related costs. Accurate determinations of titer and yield are essential for cell line selection, harvest time determination, and downstream process optimization. However, the analytical methods used come with varying limitations that may affect measurements and speed. This presentation describes case studies in which the relative strengths and weakness of several commonly used techniques for titer or yield determination are discussed.

2:30pm - 3:00pm 30 mins
Info
Cell Culture & Upstream Processing
Scientific Track Presentation
2:30pm - 3:00pm 30 mins
Info
Speed from Gene to Market
Scientific Track Presentation
2:30pm - 3:00pm 30 mins
Info
Recovery & Purification
Scientific Track Presentation
2:30pm - 3:00pm 30 mins
Info
Intensified and Continuous Processing
Scientific Track Presentation
2:30pm - 3:00pm 30 mins
Info
Manufacturing Strategy
Scientific Track Presentation
2:30pm - 3:00pm 30 mins
Info
Analytical & Quality
Streamlined Impurity Analysis Using High Throughput Analytical Automation to Support Process Development and Characterisation Studies
  • Hannah L. Gibbins - Lead Scientist, Lonza Biologics

There is a need to increase capacity to meet the analytical demand for Process Development and Characterisation studies, which investigate multiple parameters in a DoE approach. High-throughput automation can reduce result turnaround time, with smaller sample volumes and increased sample numbers. This presentation describes Lonza’s latest advances in automation, focusing on Lonza’s High-Throughput Impurity Detection platform for automated impurity quantitation.

4:40pm - 5:25pm 45 mins
Networking Refreshment Break and Grand Opening of the Poster & Exhibit Hall
5:30pm - 6:05pm 35 mins
Plenary Session
Keynote Address – CMC at the Bill & Melinda Gates Medical Research Institute: Cost to Serve Drives Manufacturing and Supply
  • Jorg Thommes, PhD - Head of CMC, Bill & Melinda Gates Medical Research Institute
6:05pm - 6:40pm 35 mins
Plenary Session
Keynote Address – The Eulogy of Toby Peach
  • Toby Peach - Coney Associate, BBC Fellow in Community Theatre, Creative Climate Leader, Theatre Maker
6:40pm - 8:40pm 120 mins
Networking Cocktail Reception in the Poster & Exhibit Hall