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7:00am - 8:00am

Registration and Breakfast

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8:00am - 8:15am

Chairperson’s Opening Remarks

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8:15am - 9:00am

Keynote Address – Title to be Determined

  • Natraj Ram, Ph.D. - Senior Director, Biologics Process Development, Alkermes
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9:00am - 9:45am
Info

Plenary Panel Discussion - Together We Win! Building a Collaborative and Sustainable Strategy for Success in the Future

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.

  • Moderator: Natraj Ram, Ph.D. - Senior Director, Biologics Process Development, Alkermes
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Showing of Streams
Showing of Streams
3:00pm - 3:45pm

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

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Showing of Streams
5:00pm - 7:00pm

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
Keynote Address – Title to be Determined
  • Natraj Ram, Ph.D. - Senior Director, Biologics Process Development, Alkermes
9:00am - 9:45am 45 mins
Info
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.

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
Continuous Processing
New Ways of Running Perfusion for Next Generation Manufacturing

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
Analytical & Quality
Risk-Based Assessment of CQAs for Bispecific molecules
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
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
De-Bottlenecking the Downstream Process from Intensified Processing
  • James Angelo, Ph.D. - Scientist, Bristol-Myers Squibb
11:15am - 11:45am 30 mins
Continuous Processing
De-Bottlenecking the Downstream Process from Intensified Processing
  • 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
Cell Culture & Upstream Processing
Concurrent Technology Workshops
11:50am - 12:20pm 30 mins
Speed from Gene to Market
Concurrent Technology Workshops
11:50am - 12:20pm 30 mins
Recovery & Purification
Concurrent Technology Workshops
11:50am - 12:20pm 30 mins
Continuous Processing
Concurrent Technology Workshops
11:50am - 12:20pm 30 mins
Manufacturing Strategy
Concurrent Technology Workshops
11:50am - 12:20pm 30 mins
Analytical & Quality
Concurrent Technology Workshops
1:30pm - 2:00pm 30 mins
Info
Cell Culture & Upstream Processing
Developing a Chemically-Defined Basal Medium for Fed-Batch Production of mAbs
  • Zhongqiang Wang - Research Scientist, Gilead Sciences

Chemically-defined basal medium is a complex mixture of nutrient molecules that provides the suitable environment to support cell growth and monoclonal antibody (mAb) synthesis. Compared with the commercially available options, in-house medium has the key advantage of formulation ownership, enabling continued process improvement and efficient troubleshooting to meet project-specific needs. This work describes the development of a proprietary chemically-defined basal medium from a classic medium with publicly known formulation. Both DOE based high throughput screening and metabolomics based spent medium analysis were utilized to optimize the medium in order to: improve cell growth and viability, reduce cell aggregation, and increase mAb production. The final optimized medium was tested with multiple cell lines. Cell culture performance was similar to that of commercially available medium formulations, and product quality profiles were acceptable. This work will enable establishment of a cell culture platform process based on this medium for future pipeline projects.

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
Info
Continuous Processing
Application of Continuous Manufacturing for Viral Vaccines

A Representative from Takeda Vaccines

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
CAR-T Characterization
  • Eric Alonzo - Scientist, Cellular Analytics, Bluebird Bio
  • Cannot use the same tool the same way for gene therapy – still need to measure purity, potency and stability but techniques are different
  • Electromicroscopy
  • Field Filtration
  • Emerging analytics for these newer more complex products
2:00pm - 2:30pm 30 mins
Info
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

The structure and composition of N-linked glycans of therapeutic monoclonal antibodies can impact drug safety and efficacy. An increase in the percent of high mannose N-linked glycosylation may be required for drug efficacy or to match the glycosylation profile in the development of a biosimilar. We investigated a molecule that can increase percent high mannose glycans without impacting cell culture performance in a CHO process. Further work demonstrated a range of similar molecules that can modulate mannose structures. The molecules share a similar core structure with known mannosidase inhibitors but without impact to titer or CHO metabolism.

2:00pm - 2:30pm 30 mins
Info
Speed from Gene to Market
Auto-Population of INDs

A Representative from Genentech

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
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 biopharmaceuticals development, titer and yield are very important measures of the efficiency of a manufacturing process and related costs. Accurate and fast determinations are desired in titer and yield analysis. However, the analytical methods used come with varying limitations that may affect measurements. This presentation describes case studies in which the relative strengths and weakness of several commonly used techniques for accurate titer or yield determination are discussed.

2:30pm - 3:00pm 30 mins
Cell Culture & Upstream Processing
Concurrent Scientific & Technology Presentations
2:30pm - 3:00pm 30 mins
Speed from Gene to Market
Concurrent Scientific & Technology Presentations
2:30pm - 3:00pm 30 mins
Recovery & Purification
Concurrent Scientific & Technology Presentations
2:30pm - 3:00pm 30 mins
Continuous Processing
Concurrent Scientific & Technology Presentations
2:30pm - 3:00pm 30 mins
Manufacturing Strategy
Concurrent Scientific & Technology Presentations
2:30pm - 3:00pm 30 mins
Analytical & Quality
Concurrent Scientific & Technology Presentations
3:00pm - 3:45pm 45 mins
Networking Refreshment Break and Grand Opening of the Poster & Exhibit Hall and
3:50pm - 4:25pm 35 mins
Plenary Session
Keynote Address – Topic to be Determined
  • Jorg Thommes, PhD - Head of CMC, Bill & Melinda Gates Foundation
4:25pm - 5:00pm 35 mins
Info
Plenary Session
Keynote Address – Driving Down Cost of Manufacturing

A Representative from Just Biotherapeutics

5:00pm - 7:00pm 120 mins
Networking Cocktail Reception in the Poster & Exhibit Hall