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Key Sessions

Rebecca Sendak, PhD

Accelerating the Time to Clinic for Complex Biological Modalities

Sanofi

Jorg Thommes, PhD

Developing Monoclonal Antibodies for Influenza

Visterra Inc.

Robert Langer, ScD

High-Impact Ideas and Use-Inspired Research - A Chat with MIT's Bob Langer on How to Create Innovations That Matter

Massachusetts Institute of Technology

E. Morrey Atkinson, PhD

Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing

Bristol-Myers Squibb

Elsie DeBella, PhD

The Complex World of Biosimilar Process Development

Momenta Pharmaceuticals

Sep 05
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7:00am - 8:00am

Registration and Coffee

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

Grand Opening of the Poster & Exhibit Hall and Cocktail Reception

7:00am - 8:00am 60 mins
Registration and Coffee
8:00am - 8:20am 20 mins
Plenary Session- Driving Down Costs in Bioprocessing
Conference Opening and Welcome
  • Günter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more
8:20am - 8:50am 30 mins
Plenary Session- Driving Down Costs in Bioprocessing
Accelerating the Time to Clinic for Complex Biological Modalities
  • Rebecca Sendak, PhD - US Head of BioPharmaceutics Development, Sanofi
more

The Biopharmaceutical industry has seen an increasing complexity in biologics being brought to the market over the past several years. At the same time, speed to clinic is crucial for remaining competitive and supporting as many “shots on goal” to evaluate clinical candidates. Innovative approaches and flexible platforms can help achieve the required agility and speed needed to support the challenging array of biologics the industry is seeing today.

8:50am - 9:20am 30 mins
Plenary Session- Driving Down Costs in Bioprocessing
Developing Monoclonal Antibodies for Influenza
  • Jorg Thommes, PhD - SVP Pharmaceutical Sciences & Technology, Visterra Inc.
more
9:20am - 9:45am 25 mins
Plenary Session- Driving Down Costs in Bioprocessing
PANEL DISCUSSION: Production Economics - Cost of Ownership
  • Tom Ransohoff - Vice President & Senior Consultant, Bioprocess Technology Consultants
  • Jorg Thommes, PhD - SVP Pharmaceutical Sciences & Technology, Visterra Inc.
  • Rebecca Sendak, PhD - US Head of BioPharmaceutics Development, Sanofi
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
  • Günter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
more

This panel will explore the drivers, challenges and potential approaches for reducing the costs of biologic medicines. Specifically, the role of new technologies, obstacles to implementation of lower cost manufacturing approaches and the potential for greater collaboration across industry stakeholders in the pursuit of this goal.

9:45am - 10:10am 25 mins
Main Conference
Networking Refreshment Break and Book Signing
9:45am - 10:10am 25 mins
Breakfast Session
Understanding the science behind liquid leak and microbial ingress mechanisms as the foundation for single use container closure integrity (SU-CCI)
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech
  • Carole Langlois - Senior Product Manager, Fluid Management Technology, Sartorius Stedim Biotech FMT SAS
  • Marc Hogreve - Senior Engineer Integrity Testing, Sartorius Stedim Biotech
more

This presentation describes a scientific approach to establishing a relation between liquid leakage and microbial ingress mechanisms in single use plastic containers and developing the appropriate physical integrity testing methods and specifications.

With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on SU CCI, raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies.

The authors will first review the emerging industry association’s initiatives and introduce an integrated quality by design, material science and process control approach as the pre requisite to SU-CCI.

 

The presentation will then describe how applying good science help determine the maximum allowable leakage limit (MALL) under which no product leakage and no bacteria ingress occur with SUS under various fluids and process conditions. The understanding of liquid leakage and bacteria ingress mechanisms also enables to validate robust liquid leak tests and microbial aerosol challenge that both are correlated to the detection limits of physical integrity testing methods.

The authors will conclude with the development of highly sensitive deterministic integrity testing technologies such as gas tracer detection and pressure decay able to detect the MALL determined during the scientific study. Helium based Supplier Integrity Test (SIT) for instance is able to control the finished products with a detection limit of 2µm and is correlated to both liquid leakage and microbial ingress under all tested process conditions.


Space limited, first come first serve

10:10am - 10:15am 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
10:10am - 10:15am 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
10:10am - 10:15am 5 mins
Recovery & Purification
Chairperson's Remarks
  • John Moscariello - Vice President, AGC Biologics
more
10:10am - 10:15am 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Kenneth Green, PhD - Scientist, Industry Consultant
more
10:10am - 10:15am 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Arvind Srivastava, PhD - Vice President, Avantor, Inc.
more
10:10am - 10:15am 5 mins
Analytical & Quality
Chairperson's Remarks
  • Bo Yan, PhD - Senior Scientist I, AbbVie Bioresearch Center
more
10:15am - 10:45am 30 mins
Cell Culture & Upstream Processing
Seamless Integration of Projects Between R&D and Manufacturing
  • Gene Lee, PhD - Senior Director and US Site Head, DDTechnologies, Head, Protein & Cell Sceiences/NBE, EMD Serono
more
10:15am - 10:45am 30 mins
Speed from Gene to Market
Seamless Integration of Projects Between R&D and Manufacturing
  • Gene Lee, PhD - Senior Director and US Site Head, DDTechnologies, Head, Protein & Cell Sceiences/NBE, EMD Serono
more
10:15am - 10:45am 30 mins
Recovery & Purification
Lean Initiatives in Process Development - Impact of Development on Operations? What’s been done to Optimize the Workflow?
  • Paul Jorjorian, MEng - Senior Director, Patheon
more
10:15am - 10:45am 30 mins
Manufacturing Strategy
Cell Culture Manufacturing Continuous Process Improvement: Enhancing the Control Capability of Product Quality Attributes for Marketed Biopharmaceutical Product Lifecycle
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech
more

During biopharmaceutical process development and commercialization, the Process Validation lifecycle is started with Process Design (Stage 1), then followed by Process Performance Qualification (Stage 2) and monitored through Continued Process Verification (Stage 3) for a marketed biologics product. The CPV (Continued Process Verification), per Stage 3 of FDA Process Validation guidance, provides further assurance that a validated process remains in a state of control during the routine GMP manufacturing of a marketed biologics product lifecycle. Raw material lot-to-lot variability may potentially lead to unexpected impact on the cell culture manufacturing process performance and/or product quality attributes (e.g., slower cell growth, low titer performance and/or drifting or shifting of product quality attributes, etc.). Therefore, the manufacturing process performance and product quality attributes (PQA) are continuously monitored, verified and controlled throughout the marketed biologics product lifecycle. In this presentation, an industry case study will discuss: how a cell culture manufacturing process improvement was identified, evaluated and implemented for stabilizing and controlling the drug substance PQAs to mitigate the potential impact of raw material variability for a marketed biologics product. Multivariate data analysis, scale-down model approaches and commercial scale process validation were employed, developed and executed to improve the control capability of PQAs. The key findings presented in this study are intended to enhance biopharmaceutical manufacturing process knowledge, which is valuable for all partners across the cell culture manufacturing network.

10:15am - 10:35am 20 mins
Drug Product, Fill-Finish & Formulations
Managing Viscosity for High Concentration Protein Formulations
  • Arvind Srivastava, PhD - Vice President, Avantor, Inc.
more

An Increase in viscosity is a major challenge in developing high concentration formulations for proteins. The presentation will discuss a viscosity reduction strategy for proteins.

10:15am - 10:45am 30 mins
Analytical & Quality
Mass Spectrometry in Support of Developability and Clone Selection: Automation, Analysis and Interpretation
  • Yan Jiang, PhD - Senior Scientist, BioAnalytics Characterization, Sanofi BioPharmaceutics Development
more

Identification of important quality attributes and potential risks using mass spectrometry (MS)-based analysis during early stage developability assessment and clone selection, would greatly aid the timely decision making and avoid delays in development timelines. Here we report a high-throughput workflow for fast characterization screening, which includes automated antibody purification, sample preparation and digestion, and MS data analysis to reduce the turnaround time for large sets of samples and improve the analytical efficiency.

10:35am - 11:00am 25 mins
Drug Product, Fill-Finish & Formulations
Subcutaneous Formulation Development for Herceptin: Strategies and Lessons Learned
  • Jeremy Duboeuf - Senior Scientist and Group Leader, Roche
more

Overcoming high dose monoclonal antibody formulations for subcutaneous administration by use of recombinant hyaluronidase as permeation enhancer. Challenges of co-formulation development and manufacturing process considerations.

10:45am - 11:15am 30 mins
Cell Culture & Upstream Processing
Enhancing Speed in Development by Early Quality Assessment of Biologics
  • Daniel Heitmann, PhD - Head Portfolio and Project Management IBP, Novartis Pharma AG
more
10:45am - 11:15am 30 mins
Speed from Gene to Market
Enhancing Speed in Development by Early Quality Assessment of Biologics
  • Daniel Heitmann, PhD - Head Portfolio and Project Management IBP, Novartis Pharma AG
more
10:45am - 11:15am 30 mins
Recovery & Purification
Maximizing Productivity of Protein A Capture
  • Isabelle Savoy, MSc - Senior Scientist, Novartis Pharma AG
more
10:45am - 11:15am 30 mins
Manufacturing Strategy
Reducing Risk to CQA Out of Specification Result for a Commercialized Enzyme Replacement Therapy
  • Sarah Holtschlag - Head of Global Product Support, Shire Pharmaceuticals
more

Process capability analysis is often utilized in the biotechnology industry to determine the risk to meeting release specifications.  This case study will discuss the process improvement plan for a commercial process to reduce the risk of an out of specification result for a specific CQA.

10:45am - 11:15am 30 mins
Analytical & Quality
Understanding the Propensity of Sequence Variants During Cell Line and Culture Process Development
  • Lisa Marzilli, PhD - Associate Research Fellow and group leader, Pfizer, USA
more
11:00am - 11:25am 25 mins
Drug Product, Fill-Finish & Formulations
Formulation and Device Approaches to Design a Formulation for Subcutaneous Administration
  • Nagarajan (Raja) Thyagarajapuram, PhD - Research Advisor, Group Leader, Eli Lilly and Company
more
11:15am - 11:45am 30 mins
Cell Culture & Upstream Processing
Target Integrated Cell Line Development Platform Process and Associated Speed and Efficiency Benefits
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
more
11:15am - 11:45am 30 mins
Speed from Gene to Market
Target Integrated Cell Line Development Platform Process and Associated Speed and Efficiency Benefits
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
more
11:15am - 11:45am 30 mins
Recovery & Purification
Downstream Process Adaptions for Production for an Antibody
  • Bala Thangaraj, PhD - Scientist, Amgen Inc.
more
11:15am - 11:45am 30 mins
Manufacturing Strategy
Regulatory Lifecycle Management Strategies for Recently Commercialized Biologics
  • Andrew Seipel, PhD - Senior Manager, Regulatory Affairs CMC, Biogen
more

The nature of the pharmaceutical environment is such that optimization of the manufacturing process, supply chain or patient experience often occurs after commercialization. Integration of the regulatory strategy with the lifecycle management (LCM) and commercial plan is critical to ensure that manufacturers have the flexibility to optimize their process and products and adapt to unforeseen challenges for recently commercialized products. Review of global registration and post-approval variation submissions for biologics launched within the last 5 years has identified the regulatory complexities and challenges unique to lifecycle management of new products. The analysis presented demonstrates the impact upon LCM by marketing application review timelines, non-harmonized regulatory guidelines, GMP requirements and other factors. Novel strategies and best practices critical to maximizing flexibility within a continuously shifting global regulatory landscape are highlighted.

11:15am - 11:45am 30 mins
Analytical & Quality
Rapid Characterization of Biotherapeutics using Capillary Electrophoresis Mass Spectrometry
  • Bo Yan, PhD - Senior Scientist I, AbbVie Bioresearch Center
more

We applied a microfluidic capillary electrophoresis (CE) device coupled with MS for rapid characterization of biotherapeutics, such as monoclonal antibodies (mAbs), fusion proteins, and protein mixtures. This method provides fast separation, different elution profile relative to LC, and exceptional sensitivity for peptide mapping and post-translational modification detection of biotherapeutics.

11:25am - 11:45am 20 mins
Drug Product, Fill-Finish & Formulations
Presentation TBA
  • Vineet Kumar, Ph.D. - Associate Director and Group Leader, Johnson & Johnson
more
11:50am - 12:20pm 30 mins
Workshop
Technology Workshops
more
11:50am - 12:20pm 30 mins
Workshop 2
Technology Workshop
more
11:50am - 12:20pm 30 mins
Workshop 3
Technology Workshop
more
11:50am - 12:20pm 30 mins
Workshop 4
Technology Workshop
more
11:50am - 12:20pm 30 mins
Workshop 5
Technology Workshop 5
more
11:50am - 12:20pm 30 mins
Workshop 6
From DNA Sequence to GMP Manufacturing – A Year-Long Upstream Case Study
more

Leveraging experience and collaborative decision making to select a rapid yet thorough development path from DNA sequence to a manufacturable process for a therapeutic monoclonal antibody. An outline for strategic decision making of upstream development will be presented.

12:20pm - 1:25pm 65 mins
Presentation 1
Luncheon Presentation
more
12:20pm - 1:25pm 65 mins
Presentations 2
Luncheon Presentation
more
12:20pm - 1:25pm 65 mins
Presentations 3
A Challenge with Single-Use Technology: Protecting Bulk Drug Substance (DS) during cold chain handling, storage, and transport
more

The issue of single-use container durability during cold chain handling is well known in the biopharmaceutical market, particularly at freeze and transport temperatures down to -80°C.  The extractables and leachables profile of materials commonly used in containers is another concern.  This presentation will discuss novel technologies that address both the durability and purity challenge that biopharmaceutical manufacturers face.

12:20pm - 1:25pm 65 mins
Presentations 4
Luncheon Presentation
12:20pm - 1:25pm 65 mins
Presentations 5
Luncheon Presentation
1:25pm - 1:30pm 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
1:25pm - 1:30pm 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
1:25pm - 1:30pm 5 mins
Recovery & Purification
Chairperson's Remarks
  • John Moscariello - Vice President, AGC Biologics
more
1:25pm - 1:30pm 5 mins
Manufacturing Strategy
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Ganapathy Gopalrathnam - Senior Research Scientist, Eli Lilly & Company
more
1:25pm - 1:30pm 5 mins
Analytical & Quality
Chairperson's Remarks
  • Bo Yan, PhD - Senior Scientist I, AbbVie Bioresearch Center
more
1:25pm - 1:45pm 20 mins
Novel Technology Showcase- Single- Use Technologies
Speaker TBA
more
1:30pm - 2:00pm 30 mins
Cell Culture & Upstream Processing
Speeding Up Cell Line Development – Implementing Novel Technologies to Reduce Timelines
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
more
1:30pm - 2:00pm 30 mins
Speed from Gene to Market
Speeding Up Cell Line Development – Implementing Novel Technologies to Reduce Timelines
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
more
1:30pm - 2:00pm 30 mins
Recovery & Purification
Scalable Purification Platform Development from the Cell-Free Expression System for Site-Specific Antibody Drug Conjugates
  • Julie Hang, PhD - Associate Director, Sutro Biopharma
more
1:30pm - 2:00pm 30 mins
Manufacturing Strategy
Capacity Planning for a Growing Specialty Care Portfolio
  • Joseph Neal, MSc, MBA - Manager, Biologics Operations Strategy, AstraZeneca
more

AstraZeneca has experienced tremendous growth in its Biologics portfolio with three new specialty care medicines launched in 2017 and more launches expected in the future. The specialty portfolio demands industry leading customer service for large unmet patient need and high demand variability. To meet this challenge, the end to end supply chain needs to be an integrated and interdependent network delivering reliable and agile supply at the right cost. This discussion will highlight an approach to managing long term capacity planning across highly variable NPI programs, integration of demand signals across the organization, and timely capacity sanctions to ensure a Supply Network capable of delivering critical medicines to patients.

1:30pm - 2:00pm 30 mins
Drug Product, Fill-Finish & Formulations
Subcutaneous Injection Physiology Research to Improve Biologics Delivery and the Patient Experience
  • Michael Harrison, PhD - Director, Delivery and Device Innovation, Eli Lilly
more

Understanding subcutaneous tissue physiology and injection biomechanics will better inform formulation and delivery system design to minimize pain and improve tolerability of subcutaneous injections. This presentation will discuss advances in understanding pain and tolerability of subcutaneous injections and review work we are doing to build upon this knowledge to optimize product design.

1:30pm - 2:00pm 30 mins
Analytical & Quality
Applying LC-MS Multi-Attribute Method (MAM) to Accelerate Biopharmaceutical Development and Release
  • Li Zang, PhD - Associate Director, Analytical Development, Biogen
more

The multi-attribute method (MAM) based on LC-MS peptide mapping has demonstrated its capability in quantitating post-translational modifications (PTMs) and detecting sequence variants, as well as other impurities, such as host-cell proteins in protein biopharmaceuticals. The quantitative information of PTMs from MAM such as oxidation, deamidation, isomerization, clipping as well as N-glycosylation are potentially directly linked to the purity, impurity, N-glycan and charge heterogeneity profiles of the biopharmaceuticals. Some of the PTMs are correlated with the biological functions of the biopharmaceuticals. For example, levels of Fc methionine oxidation, afucosylation are correlated with the mAb Fc effector functions. High mannose glycan level on mAb Fc not only affects Fc effector function but also reflects the PK clearance of mAb. The capability of MAM to report quantitative information of these PTMs offers an opportunity to replace multiple conventional biochemical and bioassay tests using the MAM in protein pharmaceutical development and manufacturing.  Software packages that perform automatic processing and storage in a database format of MAM data can be powerful tools to manage the knowledge gathered during the lifetime of a biopharmaceutical from clone screening, process development and characterization to commercial manufacturing and release. Examples of MAM used for mAb clone screening and process development as well as potential replacement of selected release assays using MAM for a mAb will be demonstrated in the talk.

1:45pm - 2:05pm 20 mins
Novel Technology Showcase- Single- Use Technologies
Speaker TBA
more
2:00pm - 2:30pm 30 mins
Cell Culture & Upstream Processing
PANEL DISCUSSION – Strategies for Increasing Use of Pool Clones for Tox and Clinical Material
  • Dot Reilly - Principal Scientist/Associate Director, Genentech, Inc; USA
  • Subinay Genguly, PhD - Associate Director, CMC Team Lead, Centocor Research & Development, Inc.
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
more
2:00pm - 2:30pm 30 mins
Speed from Gene to Market
PANEL DISCUSSION – Strategies for Increasing Use of Pool Clones for Tox and Clinical Material
  • Dot Reilly - Principal Scientist/Associate Director, Genentech, Inc; USA
  • Subinay Genguly, PhD - Associate Director, CMC Team Lead, Centocor Research & Development, Inc.
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
more
2:00pm - 2:30pm 30 mins
Recovery & Purification
Development of a Scalable Manufacturing Process for the Purification of Exosomes
  • Kimberly Ellis, MSE - Senior Research Associate, Codiak Biosciences
more
2:00pm - 2:30pm 30 mins
Manufacturing Strategy
Implementation of BPOG’s Biomanufacturing Technology Roadmap: Progress, Challenges and Prospects
  • Rajesh Beri, Ph.D. - Technical Director Research & Technology, BioManufacturing, Lonza
more

Over 30 organizations representing Biomanufacturers, Technology suppliers and Academic institutions participated in developing a first of its kind Technology Roadmap for Biologics Manufacturing. The BPOG TRM published in July 2017 has generated considerable interest within the Industry. Over 100 critical needs were identified by the six Roadmap sub teams to achieve the 10-year vision of lower Cost of Goods, increased quality and speed and increasing diversity of facility design. 12 key projects addressing the respective critical needs were initiated in October 2017 by the participating organizations. At the conclusion of year 1, the progress made as well as retrospective inspection of the Tech Roadmap effort and future prospects will be reviewed during this presentation.

2:00pm - 2:30pm 30 mins
Drug Product, Fill-Finish & Formulations
The Interplay between User Requirements, Target Product Profile and Delivery Device Design Inputs
  • Jeffrey Givand, PhD - Director, Device Development, Merck, Sharp & Dohme
more

Development of high concentration biologic parenteral formulations presents unique challenges to formulation and device development scientists. Employing user-focused research to understand the use environment and capabilities enables clearer definition of product requirements. With this knowledge, development teams are then able to determine the most optimal approach to address these requirements.

2:00pm - 2:30pm 30 mins
Analytical & Quality
Determination of Proteins Detected by Host Cell Protein ELISA Assays
  • Martha Staples, PhD - Senior Scientist, Sanofi
more
2:05pm - 2:25pm 20 mins
Novel Technology Showcase- Single- Use Technologies
Speaker TBA
more
2:25pm - 2:40pm 15 mins
Novel Technology Showcase- Single- Use Technologies
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Cell Culture & Upstream Processing
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Speed from Gene to Market
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Recovery & Purification
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Manufacturing Strategy
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Drug Product, Fill-Finish & Formulations
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Analytical & Quality
Short Refreshment Break
2:45pm - 3:30pm 45 mins
Keynote Presentations
High-Impact Ideas and Use-Inspired Research - A Chat with MIT's Bob Langer on How to Create Innovations That Matter
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
more
3:30pm - 4:15pm 45 mins
Keynote Presentations
Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
more
4:15pm - 5:00pm 45 mins
Keynote Presentations
The Complex World of Biosimilar Process Development
  • Elsie DeBella, PhD - Vice President, Biologics Process and CMC Development, Momenta Pharmaceuticals
more
5:00pm - 7:00pm 120 mins
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception