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Key Sessions

Lauren Jones

Welcome to Biotech Week Boston

City of Boston

Dean Pettit, Ph.D.

Improving Global Access to Biotherapeutics Through Molecule, Process and Manufacturing Design

Just Biotherapeutics

Flemming Ornskov, M.D., M.P.H.

A Vision for Rare Disease: How We Can Champion Underserved Patients

Shire

James Collins, Ph.D.

Synthetic Biology: Biomedical Applications Come of Age

Massachusetts Institute of Technology

7:30am 8:10am (40 mins)

Main agenda

Registration and Coffee

8:10am 8:15am (5 mins)

Cell Culture & Upstream Processing

Chairperson's Opening Remarks

  • Serena Smith - Associate Director Global Technical Engagements, Thermo Fisher Scientific

8:15am 8:45am (30 mins)

Cell Culture & Upstream Processing

Custom Single Use Bioreactor and Process Development for Cell Culture in Collaboration Between Genentech and Thermo Fisher Scientific

The Cell Culture Pilot Plant at Genentech in South San Francisco is a hybrid facility that uses both stainless steel and disposable bioreactors for CHO cell culture in Seed Train, Inoculum Train, and Production stages. In the biotech industry, disposable rocker bioreactors have been used as Seed Train and Inoculum Train operations due to their efficient, cost effectiveness, and small footprint. In 2016, Cell Culture Pilot Plant evaluated a rocker bioreactor for both Seed Train and Inoculum Train processes and found the rocker system did not have a robust pH and dO2 control for continuous Seed Train process that can run for up to 5 months. To address these challenges, Genentech and Thermo Fisher collaborated to modify a 30L Single Use Fermentor bag (SUF) to a 30L Single Use Bioreactor bag (SUB) that matches a traditional 20L stainless steel bioreactor including robust pH and dO2 control. As part of this evaluation, mass transfer and cell culture experiments were performed. The presentation will be focusing on cell culture performance data, ongoing efforts to resolve equipment associated challenges, and expand the use of the 30L SUB in Inoculum Train.

  • Edward Chan - Technical, Cell Culture Pilot Plant, Genentech, Inc
  • Nephi Jones - Manager, Advanced Technology, Research & Development, Thermo Fisher Scientific

8:45am 9:15am (30 mins)

Cell Culture & Upstream Processing

Process Optimization and Scale-Up Challenges in the Development of a Large-Scale Chemically-Defined Phase III/Commercial Manufacturing Cell Culture Process

Developing a Phase III/commercial cell culture process can present challenges including optimizing cell culture conditions for maximized productivity while maintaining product quality consistent with the needs of the clinical development program. Development of a phase III/commercial process will be described for a CHO monoclonal antibody product through process optimization and scale-up. A new chemically-defined medium (CDM) formulation was implemented for this process at large scale for the first time. The use of this CDM formulation resulted in highly consistent cell culture performance at both small scale and pilot scale. However, during scale-up for clinical manufacturing, challenges were identified and investigated. Details of this investigation and the process / operational improvements implemented at large scale for Phase III and qualification runs will be presented.

  • Jason Goodrick - Senior Engineer, Late Stage Cell Culture, Genentech, Inc.

9:15am 9:45am (30 mins)

Cell Culture & Upstream Processing

Case Study of Custom Production Medium Development in Collaboration between Eisai And Thermo Fisher Scientific

EISAI / Morphotek Wei Gu, Jennifer Long, Eric Evans & Frank Lee

THERMOFISHER  Jamie LaPierre and Andy Campbell

The development of a custom production medium platform has several benefits for a biologic drug development process: 1) freedom to optimize the production medium platform for obtaining a robust cell culture process specific for cell lines; 2) better understand the effect of production medium platform and production process on protein characteristics; 3) COGS reduction .  Previously, Eisai and Thermo Fisher Scientific entered into a collaboration to achieve this goal.  In stage I, two large DOE screening studies were performed in shake flasks, where 24 prototype basal media and 2 prototype feeds were evaluated with two Eisai cell lines, and the other with 3 modified prototype basal media and 8 modified prototype feeds (tested with the addition of one new feed supplement) on seven Eisai cell lines.  After extensive data analysis for culture performance, production titer, and spent medium analysis, one prototype set of basal medium (BM1), feed (Feed6), and feed supplement was selected for further evaluation in bioreactors.  Numerous runs at 2L were conducted to optimize feeding strategy (e.g. feeding methodology, feeding rate, and feeding duration), operation conditions (e.g. pH set point with dead band and agitation speed), and a more concentrated Feed6 formula for minimizing the total feeding volume.  The optimized condition was robustly further scaled up from 2L to 10L with same production level.  In conclusion, the optimized production medium and feed platform could robustly produce monoclonal antibody under optimal conditions exceeding the third party’s production medium platform with comparable protein characterization, while improving COGs and freedom for further optimization.  The AGT format of this custom medium platform is currently in evaluation for manufacturability.

  • Wei Gu, Ph.D. - Group leader, Morphotek

8:10am 8:15am (5 mins)

Manufacturing Strategy

Chairperson's Opening Remarks

  • Udayanath Aich, Ph.D. - Principal Scientist, Bioanalytics, Sanofi-Genzyme

8:15am 8:45am (30 mins)

Manufacturing Strategy

Approaches for Next-Generation Manufacturing

In an environment where there is an increasing challenge involving low cost constraints for future manufacturing, taking into account both facility and operational costs, a new approach to facility design and its operation is required. The innovative approaches taken to address these challenges in Biogen’s Next Generation Manufacturing Facility, currently under construction in Switzerland, are reviewed.  The facility design and qualification concepts together with the guiding principles for Operations are discussed.

  • Matthew Johnson, Ph.D. - Director, Strategic Innovation Leadership, Biogen

8:45am 9:15am (30 mins)

Manufacturing Strategy

A Technology Roadmapping Process to Transform the Biopharmaceutical Manufacturing Industry

What prompts over 100 biopharmaceutical manufacturers, leading academics, supply partner R&D heads, regulators, and worldwide regional hubs to get involved in a major project? It’s when that project identifies the future technology needs of the biopharmaceutical manufacturing industry and accelerates its collective innovation. The complexity of the current industry structure has held back innovation, with many biomanufacturers trying to develop new technology in isolation, whilst supply partners have to often guess common industry requirements. Over the last two years, BioPhorum Operations Group’s (BPOG’s) technology roadmapping collaboration has brought together 26 of the biopharmaceutical industry’s top companies, along with leading academics, to establish an industry technology strategy that is already starting to align the industry’s innovation efforts. To reach this point, a strong steering committee was established with a shared vision of the future of biomanufacturing, responding to the market trends towards lower cost, in-region and flexible capacity. The drivers and metrics from this shared vision triggered the mobilization of over 90 industry experts onto 6 teams focused on the key enabling technologies of in-line monitoring & real-time release, process technology, automation, modular & mobile, knowledge management and supplier partnerships. Each team has now established detailed technology roadmaps that combine to provide a roadmap for the next 10 years for the global biotech industry, which will be subsequently freely published to enable broad dissemination and a wider industry response. In this presentation we will talk about highlights from the roadmap as well as the problems, challenges and solutions, and how the work of the 6 teams integrates. The first publication of the roadmap will be just the beginning, like every strategy it will be refreshed and updated regularly, and we are looking for input and comment now and after publication in May. We will also be facilitating and tracking the industry’s progress towards the future vision. This presentation will also focus on advances in in-line monitoring and the future prospect of real time release.

  • Udayanath Aich, Ph.D. - Principal Scientist, Bioanalytics, Sanofi-Genzyme

9:15am 9:45am (30 mins)

Manufacturing Strategy

Choosing the Right Approach for Your Biomanufacturing Strategy

When launching a new product, biopharma companies face many challenging scenarios. This presentation will evaluate the many decisions biopharma executives face, such as insourcing vs. outsourcing, large-scale vs. small-scale, single-use vs. stainless steel, etc., and the decision-making process they can leverage in order to select the development path that works best for them.

  • Ned Gordon - Vice President, Strategic Marketing, Patheon
  • Bradley Johnson, Ph.D. - Manager, Purification Development, Patheon Biologics

8:10am 8:15am (5 mins)

Recovery & Purification

Chairperson's Opening Remarks

  • Paul Lynch - Director of Purification, Thermo Fisher Scientific

8:15am 8:45am (30 mins)

Recovery & Purification

A Comprehensive Regeneration Strategy for Protein and Affinity Resin in Monoclonal Antibody (mAb) Purification

Regeneration strategy for Protein A chromatography plays an important role in therapeutical monoclonal antibody (mAb) production. A robust and efficient regeneration procedure ensures product quality, improves resin life time and reduces the cost of the purification processes, particularly for those using expensive protein A resins, such as MabSelect SuRe, which is the most popular Protein A resin used in mAb purification. Microbial killing capability, cleaning efficiency and resin compatibility are the three major aspects to consider in regeneration strategy design. Traditionally, MabSelect SuRe resin is regenerated by 200 mM NaOH and such high NaOH concentration is the leading cause of resin performance loss during the reuse. This work reported a comprehensive strategy, which applying benzyl alcohol with acetic acid, and benzyl alcohol with low concentration N aOH (< ;100 mM) in sequence, to regenerate MabSelect SuRe resin. The new regeneration strategy demonstrated efficient cleaning with improved microbial killing capability and prolonged resin life time. The resin life cycle study demonstrated that the life time of the MabSelect SuRe resin was extended 50% with new strategy.

  • Lu Wang, Ph.D. - Senior Scientist, Purification Development and Operations, CMC Biology, Teva Pharmaceutical Inc.

8:45am 9:15am (30 mins)

Recovery & Purification

Development of Product Specific Affinity Resin for Capture and Purification of Biologics

  • Andrew Keefe, Ph.D. - Senior Engineer, Downstream Development, Shire

9:15am 9:45am (30 mins)

Recovery & Purification

Functionalized Nanofiber Membranes

Column chromatographic separation of antibodies using protein A conjugated resins has been the industry standard for decades. Advances in resins have been limited to stabilizing the ligand against harsh conditions or incrementally improving the binding capacity. The challenge of using affinity resins continues to be the cycle times and binding capacity with only incremental improvements over time. Bionanoparticles (BNPs), produced by genetically engineered E. coli through a simple fermentation process, are a naturally derived, inexpensive alternative to conventional resins, but which have inherent physical challenges . Embedding protein A, or other ligand displaying BNPs onto the surface of membranes demonstrate the short cycle times of membrane chromatography with increased binding capacity over traditional resins. The resulting increases in recovery efficiency may ena ble single use products for antibody capture.

  • Karl Schilke, Ph.D. - Assistant Professor, Chemical Biological and Environmental Engineering, Oregon State University

8:10am 8:15am (5 mins)

Analytical & Quality

Chairperson's Opening Remarks

  • Carly Daniels, Ph.D. - Senior Scientist, Pfizer

8:15am 8:45am (30 mins)

Analytical & Quality

Leveraging the MAM to Reveal New CQAs for Biotherapeutics

Characterization of biotherapeutics using mass spectrometry has resulted in a better understanding of the post-translational modifications (PTMs) that are crucial for safety and efficacy. We have developed and implemented a mass spectrometry based multi-attribute method (MAM) that monitors known PTMs but also can identify new PTMs on biotherapeutics.

  • Richard Rogers - Scientist, Just Biotherapeutics Inc

8:45am 9:15am (30 mins)

Analytical & Quality

Emerging Mass Spectrometry Technologies for Bioprocess Research and Development

This talk will focus on emerging mass spectrometry technologies for bioprocess research and development. We will cover peptide mapping and intact protein analyses through a variety of mass spectrometry techniques, including multi-attribute monitoring and charge-based separation.

  • Carly Daniels, Ph.D. - Senior Scientist, Pfizer

9:15am 9:45am (30 mins)

Analytical & Quality

Integrating Novel Analytical Tools into Development Workflow of Biologics: nanoDSF and MST for Discovery, Development and QC

Biophysical approaches are routinely used to assess biologics activities, stability and quality. Modern drug discovery operations require characterization of biomolecular interactions to be both time- and cost-effective as well as to be highly precise and reproducible. Here we report applications of two novel methods nano-Differential Scanning Fluorimetry (nanoDSF ) and MicroScale Thermophoresis (MST) that we are applying in our biologics discovery and characterization operations. The examples of the demonstrated effectiveness of the nanoDSF and MST will be presented and discussed.

  • Alexey Rak, Ph.D. - Head of Bio Structure and Biophysics, Sanofi R&D

8:10am 8:15am (5 mins)

Drug Product, Fill-Finish & Formulations

Chairperson's Opening Remarks

  • Camellia Zamiri, Ph.D. - Technical Development Senior Scientist, Late Stage Pharmaceutical Development, Genentech

8:15am 8:45am (30 mins)

Drug Product, Fill-Finish & Formulations

Case Studies Demonstrating Challenges, Solutions, and Process Improvements Associated with the Drug Product Manufacturing Process of Biopharmaceuticals

This presentation will summarize several challenges encountered during drug product manufacturing of biopharmaceuticals. Challenges may become apparent during the technical transfer phase but may also occur after routine manufacturing is underway. Three case studies will be presented at various product life-cycle phases. One involves filling of high-concentration mAb formulations and improvements in the filling process to increase robustness. The second involves a challenge associated with a thaw-rate sensitive product after transfer from one manufacturing site to another with impact to filterability, and a simple fix to resolve the problem. The third involves a lyophilized product where challenges were encountered and resolved over the product life-cycle including cosmetic issues, which were shown to have no impact on product quality, and drift in component dimensions that initially led to product rejects.

  • James Colandene, Ph.D. - Manager, Drug Product Sciences, GlaxoSmithKline

8:45am 9:15am (30 mins)

Drug Product, Fill-Finish & Formulations

Unexplored Benefits of Controlled Ice Nucleation During Lyophilizastion

Lyophilization of proteins with controlled ice nucleation prior to the primary drying step has been successfully applied to reduce the primary drying time without causing any significant impact on product quality. Controlled ice nucleation lyophilization has also been applied to reduce reconstitution time for highly concentrated lyophilized products. However, the range of benefits of controlled ice nucleation has not been fully explored. A case study for a high-concentration monoclonal antibody solution will be presented that confirms previously published benefits and identifies new benefits of controlled ice nucleation during lyophilization.

  • Subhadra Singh, Ph.D. - Investigator, Biopharm Product Sciences, GlaxoSmithKline R&D

9:15am 9:45am (30 mins)

Drug Product, Fill-Finish & Formulations

Case Studies on the Impact of Changes of Drug Substance on Final Fill-Finish Product

  • Shen Chen, Ph.D. - Director, PEH R&D Drug Product Contract Manufacturing Services, Pfizer

8:10am 8:15am (5 mins)

Viral Safety

Chairperson's Opening Remarks

  • Andrew Zydney, Ph.D. - Distinguished Professor and Department Head, Chemical Engineering, The Pennsylvania State University

8:15am 8:45am (30 mins)

Viral Safety

KEYNOTE -- Looking Backward & Forward to the Future of Viral Safety: an Historical First-hand Perspective of Poliovirus

Dr. Wimmer will reflect on the challenges and advances of over 50 years of research on poliovirus, how the fields (and controversy) of pathogen safety and synthetic biology have evolved, and to muse on where these fields may be headed.

  • Eckard Wimmer, Ph.D. - Distinguished Professor and NAS Scholar, Stony Brook University

8:45am 9:15am (30 mins)

Viral Safety

The CAACB Virus Contamination In Biomanufacturing Project - Practical Lessons For Current And Emerging Biotherapeutic Products

  • James Leung, Ph.D. - Senior Research Fellow, Massachusetts Institute of Technology

9:15am 9:45am (30 mins)

Main agenda

WORKING GROUP The trouble with scale – why is it so difficult to scale up or scale down? What are the best practices for doing so?

WORKING GROUP - will continue through break


The trouble with scale – why is it so difficult to scale up or scale down? What are the best practices for doing so?

Andrew Zydney

Distinguished Professor

Department of Chemical Engineering

The Pennsylvania State University

Scale-up and scale-down are critical aspects of bioprocess development and validation, particularly in the context of virus clearance.  Yet, the virus clearance performance evaluated at different scales often shows significant discrepancies.  This networking session will examine some of the underlying phenomena governing the performance at different scales, including differences in feed streams (e.g., aggregate levels, storage effects), differences in equipment (e.g., flow distribution, hold-up volume), and differences in process implementation (e.g., process disruptions, transients).  Efforts will be made to identify best practices that can facilitate more effective scale-up and scale-down of chromatographic, membrane, and inactivation steps for virus clearance.

  • Andrew Zydney, Ph.D. - Distinguished Professor and Department Head, Chemical Engineering, The Pennsylvania State University

9:45am 10:15am (30 mins)

Main agenda

WORKING GROUP The trouble with scale – why is it so difficult to scale up or scale down? What are the best practices for doing so?

Continued from 9:15am morning session ...


The trouble with scale – why is it so difficult to scale up or scale down? What are the best practices for doing so?

Andrew Zydney

Distinguished Professor

Department of Chemical Engineering

The Pennsylvania State University

Scale-up and scale-down are critical aspects of bioprocess development and validation, particularly in the context of virus clearance.  Yet, the virus clearance performance evaluated at different scales often shows significant discrepancies.  This networking session will examine some of the underlying phenomena governing the performance at different scales, including differences in feed streams (e.g., aggregate levels, storage effects), differences in equipment (e.g., flow distribution, hold-up volume), and differences in process implementation (e.g., process disruptions, transients).  Efforts will be made to identify best practices that can facilitate more effective scale-up and scale-down of chromatographic, membrane, and inactivation steps for virus clearance.

  • Andrew Zydney, Ph.D. - Distinguished Professor and Department Head, Chemical Engineering, The Pennsylvania State University

9:00am 5:00pm (480 mins)

Two Day Training Course

Two Day Training Course: Introduction to Biopharmaceutical Manufacturing

This course provides a fundamental understanding of biopharmaceutical manufacturing.  Organized along the development path, the course will describe the activities necessary to bring a biopharmaceutical from discovery to market. Included in the course will be the analytical, quality and regulatory challenges as well as the technical activities required. The instructors will discuss how development activities integrate and the best practices for drug substance and drug product production.  At the conclusion of the course the attendee will have learned the steps needed to develop and produce a safe and effective biopharmaceutical that meets industry and patient needs. Identified during the course will be how to implement QbD in development and communicating with regulatory agencies throughout development.

  • Sheila Magil, Ph.D. - Senior Consultant, BioProcess Technology Consultants
  • Frank Riske, Ph.D. - Consultant, BioProcess Technology Consultants

9:00am 5:00pm (480 mins)

Two Day Training Course

Two Day Training Course: CMC Analytical, Comparability and Stability Studies

This course provides a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products from the preclinical phase through clinical trials to commercialization and post-approval. Analytical considerations for a wide variety of biopharmaceuticals are discussed, including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates). Details are presented on establishing and maintaining product reference standards, designing successful comparability tests (including specifics for biosimilar studies), setting meaningful product specifications, conducting forced degradation studies, technology transfer and bridging changes in analytical methods and generating effective stability protocols. Critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through cGMP are illustrated.

  • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC

9:45am 10:10am (25 mins)

Main agenda

Networking Refreshment Break

10:10am 10:15am (5 mins)

Viral Safety / Recovery & Purification

Chairperson's Remarks

  • Rosemary Versteegen, Ph.D. - CEO, International Serum Industry Association

10:15am 10:45am (30 mins)

Viral Safety / Recovery & Purification

Risk Management of Animal Derived Materials

The presentation will discuss several ways of managing the risks associated with the use of animal derived materials such as serum.These will include traceability certification, trace element testing for geographic origin, the use of bio-markers to determine the age of the source animal and gamma irradiation as the preferred method of post manufacturing treatment of serum.

  • Rosemary Versteegen, Ph.D. - CEO, International Serum Industry Association

10:45am 11:15am (30 mins)

Viral Safety / Recovery & Purification

Raw Material Qualification – A Practical Approach

Abstract: There are many questions about how to approach raw material qualification as part of an overall raw material quality program.  This discussion considers a risk-based strategy as part of a raw material qualification program.  Important parameters and the basic nuts and bolts of a qualification program are discussed.

  • Aurora Henry - Raw Materials Specialist, CMC Biologics

11:15am 11:45am (30 mins)

Viral Safety / Recovery & Purification

Elucidation of Raw Material Contribution to Process Impurities and the Development of a Predictive Model to Ensure Process Consistency

The talk, Elucidation of Raw Material Contribution to Process Impurities and the Development of a Predictive Model to Ensure Process Consistency, will be based on this article: 

Elucidation of Chromatography Resin and Loading Material Contributions to Impurity Levels and the Development of a Predictive Model to Ensure Consistency in Impurity Clearance for a Drug Substance Manufacturing Process

Hector J. Nogueras, Myra Coufal and Deborah Soto Ortega

 

 

The purpose of the second chromatography step in a particular Amgen Drug Substance (DS) manufacturing process is to reduce levels of host cell proteins.  Characterization experiments identified the resin lot-to-lot variability as a one of the major contributors to host cell protein clearance variability.  Therefore, a resin pre-use evaluation program using a small-scale model (SSM) was implemented to identify resin lots with high impurity clearance capability prior to use at commercial scale.  Further commercial experience suggested that a more extensive evaluation of the resin properties was necessary.  This observation triggered a collaboration study with the vendor to evaluate the resin properties and its effect in host cell protein clearance.  From the evaluation, a custom Design of Experiment (DoE) was completed using ligands content and % end capper as factors and second chromatography step host cell protein levels as the model response.  The DOE revealed that the best host cell protein clearance was observed with an increase in end-capper % and an increase in the amount of one of the two ligands evaluated.  In parallel, a multivariate statistical model combining commercial scale, small-scale, and resin certificate of analysis results was developed and confirmed to predict the impurity levels for a combination of loading material and resin lot.  The predictive model (R2=0.85 and Q2=0.82) is not only being used to predict impurity levels under the specific commercial-scale conditions, but also has eliminated the need for increased resources and time to perform the resin pre-use evaluation at laboratory scale.

  • Hector Nogueras, Ph.D. - Senior Associate Scientist, Amgen

10:10am 10:15am (5 mins)

Analytical & Quality

Chairperson's Remarks

  • Carly Daniels, Ph.D. - Senior Scientist, Pfizer

10:15am 10:45am (30 mins)

Analytical & Quality

Analytical Characterization of Process Impurities in Biopharmaceuticals

  • Zhikai Zhu, Ph.D. - Senior Scientist, Analytical Development, Process Sciences, AbbVie

10:45am 11:15am (30 mins)

Analytical & Quality

General Strategies for Characterization of Subvisible Particles(SVP) Based on Product Specific SVP Library

Recently, requirements for evaluation of Subvisible particles (SVP) in biological products have been increasing. For example, the guidance for immunogenicity assessment for therapeutic protein products from FDA was issued on August 2014 and several general chapters about SVP in therapeutic protein injections were added in United States Pharmacopeia. The product specific library which contains samples with various SVP and protein concentration was prepared and analyzed by orthogonal methods; semi-quantitative laser diffraction (sqLD), resonant mass measurement (RMM), multi-angle light scattering with field-flow fractionation (FFF-MALS), dynamic light scattering (DLS), light obscuration (LO), flow imaging microscopy (FIM) and so on. Comprehensive evaluation of analytical parameters for each method revealed preference and limitation by sample’s SVP concentration, SVP size, and background protein concentration. General strategies for characterization of SVP will be proposed based on the results obtained from those studies.

  • Yu Hayashi - Researcher, Astellas Pharma, Inc.

11:15am 11:45am (30 mins)

Analytical & Quality

Monitoring of Methionine Oxidation in Antibody-drug Conjugates (ADCs) by UV-UPLC

Methionine oxidation in the heavy chain CH2 domain of antibody-drug conjugates (ADCs) may be responsible for higher-order structure changes. A peptide mapping method was developed using ultra-performance liquid chromatography (UPLC) with UV absorption detection for quantification of the oxidation level of methionine. We will present the method optimization that allowed us to increase the throughput of the assay. The final method was successfully transferred to the QC department.

  • Alexandra Zaitsev - Development Associate II, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.

10:10am 10:15am (5 mins)

Manufacturing Strategy

Chairperson's Remarks

  • Udayanath Aich, Ph.D. - Principal Scientist, Bioanalytics, Sanofi-Genzyme

10:15am 10:45am (30 mins)

Manufacturing Strategy

Closed Systems in CNC Ballroom, A Risk Based Approach

Regulatory precedence tends to overrule scientific arguments in pharmaceutical companies’ selection of appropriate room classification for production of non-sterile API products. Regulatory authorities have for some time wanted companies to use risk assessment processes when assessing and designing pharmaceutical facilities. Many companies are still in doubt how to do this and how to act according to these evaluations. Closed systems and ballroom design have a profound impact on facility design, construction, qualification, capital and operational costs. This presentation elaborates the work of BPOG members to harmonize and define tools to evaluate appropriate room classification requirements across the biopharmaceutical industry. In this session, the audience will learn how risk based tools can be applied to gain significant cost savings designing new facilities or within their current facilities by reducing classified areas.

  • Lars Hovmand-Lyster, M.D. - Principal Scientist Recovery, Diabetes Active Pharmaceutical Ingredients, Novo Nordisk, Denmark

10:45am 11:15am (30 mins)

Manufacturing Strategy

Application of the Science - Case Studies Outlining Successful Methods to Reduce Area Classification Utilizing Closed Systems

This presentation will share data that demonstrates that it is possible to use closed system technology to be able to operate in a CNC environment. It will discuss how this approach can be implemented by the industry, thus reducing facility complexity and costs.

  • Kavita Ramalingam Iyer, Ph.D. - Associate Director, Global Regulatory Affairs and Clinical Safety - CMC Vaccines, Merck Sharp & Dohme Corp.

10:10am 10:15am (5 mins)

Drug Product, Fill-Finish & Formulations

Chairperson's Remarks

  • Camellia Zamiri, Ph.D. - Technical Development Senior Scientist, Late Stage Pharmaceutical Development, Genentech

10:15am 10:45am (30 mins)

Drug Product, Fill-Finish & Formulations

Challenges of Using Closed System Transfer Devices for Preparation of Monoclonal Antibodies for an Intravenous Infusion Administration

The use of closed system transfer devices (CSTDs) for preparation of monoclonal antibody (mAb) IV products at clinics is increasing. The in-use compatibility of several CSTDs from different aspects including stopper coring/fragmentation, extrinsic particles, extractable volume, and product quality impact for a mAb were assessed. Several different challenges including a case of impact to product quality were observed.

  • Camellia Zamiri, Ph.D. - Technical Development Senior Scientist, Late Stage Pharmaceutical Development, Genentech

10:45am 11:15am (30 mins)

Drug Product, Fill-Finish & Formulations

Satisfying Very-High Dose Needs of Biologics: Ultra-High Concentration Formulation Development, Manufacturing and Delivery

A lot of Immunology and Oncology biologics have very-high dose needs. However, only a patient-centric dosage can provide the much needed edge over the competitors. The talk takes a step forward over the high concentration scenario and focuses on discussing the development, manufacturing and delivery challenges of very-high dose, ultra-high concentration formulations (with examples).

  • Vineet Kumar, Ph.D. - Principal Scientist, Johnson & Johnson

11:15am 11:45am (30 mins)

Drug Product, Fill-Finish & Formulations

Late Breaking Presentation

10:10am 10:15am (5 mins)

Cell Culture & Upstream Processing

Chairperson's Remarks

  • Douglas Osborne - Senior Manager, Upstream Pilot Scale, Cell Culture Development, Biogen, Inc.

10:15am 10:45am (30 mins)

Cell Culture & Upstream Processing

Scale-Down Model of N-1 Perfusion Seed Bioreactor for High-Throughput Analysis

In the CHO-based monoclonal antibody manufacturing, the N-1 perfusion seed culture was reported to have the capability of supporting high-inoculum seeding in the production bioreactor, thus largely increase the volumetric productivity and shorten the duration for the production phase. However, due to the ineligibility of the small-scale perfusion bioreactors, further process development in N-1 perfusion requires a proper scale-down model to perform perfusion medium optimization, clone selection and other operation optimizations. In our research, we developed a series of scale-down models for N-1 perfusion operation based on shake flasks, cell culture tubes and deep well plates. The operating parameters of those scale-down models were optimized to match the performance in 5L N-1 perfusion bioreactors. Multiple cell lines from different CHO derivatives were tested t o verify the robustness of those scale-down models. The results indicate that the cell growth and viability are comparable between 5L N-1 perfusion and the scale-down models. Meanwhile, the cell quality and health level, estimated by LDH and apoptosis markers, are consistently high during the N-1 seed culture in both 5L N-1 perfusion and scale-down models. Furthermore, we established a workflow to perform the high-throughput DOE for N-1 perfusion culture and subsequent high-inoculum fed-batch production culture. The proof-of-concept workflow shows the adequacy to perform the medium optimization for N-1 perfusion and high-inoculum fed-batch production.

  • Yongqi Wu, Ph.D. - Scientist, Bristol-Myers Squibb

10:45am 11:15am (30 mins)

Cell Culture & Upstream Processing

Process Locked and Defined……… or is it?

The journey that future medications take from discovery to commercialization has many twists and turns and a number of those are within the process development and scale-up space. This presentation will highlight different opportunities and challenges in the upstream space such as defined media that isn’t “exactly” defined,  identical bioreactors that do not produce “identical” results, and other surprises on the journey to deliver life improving and saving therapies to the patient

  • Tiffany Rau, Ph.D. - Senior Consultant, BioProcess Technology Consultants, Inc.

11:15am 11:45am (30 mins)

Cell Culture & Upstream Processing

Cell Culture Medium Designed for Perfusion Processes: Case Studies and Impact on Upstream Process Economy

Performing high cell density perfusion processes that are economically feasible requires a good understanding of the process and the metabolic requirements of the cells. Cell culture medium is generally considered the most expensive consumable in upstream continuous processes; therefore it is essential to minimize perfusion rates while maintaining the desire specific cell density, productivity and product quality profile.

In this work, we will show that by using a catalog cell culture medium designed specifically for perfusion processes we were able to reduce the minimum cell specific perfusion rate by as much as 50%, compared to using an enriched fed-batch medium in steady state perfusion processes. An overview on the product quality attributes and their modulation in perfusion will be described as well.

We will end with an evaluation on the economic advantage of using a specialized cell culture medium in the context of different perfusion processes such as steady state and dynamic perfusion.

  • Delia Lyons, MSc. - Senior Scientist, Head Perfusion Media Development, Process Solutions, MilliporeSigma

11:45am 12:15pm (30 mins)

Cell Culture & Upstream Processing

Improving Protein Folding Control and Scalability Using imPULSE Mixing Technology

Protein folding by dilution is a common approach used in the manufacturing of biologics derived from microbial expression systems. The typically involves the solubilization of a washed inclusion body preparation containing the concentrated product polypeptide with a strong chaotrope or detergent solution. The denatured, inactive product solution is when diluted

  • Anthony Hawrylechko - Director of Microbial Bioprocess, Cytovance Biologics

11:50am 12:20pm (30 mins)

Technology Workshop

Quantifying the Impact of CO2 Gas on the pH of Frozen Sodium Phosphate When Stored in Single-Use Bags on Dry Ice

The stability of frozen solutions stored in single-use bags is a primary concern in bioprocessing. This presentation will share pH stability data from a frozen solution stored in single-use bags with different gas permeation rates that are subjected to CO2 gas from sublimating dry ice.


  • Michael Johnson - Business Development Engineering Manager, Entegris

11:50am 12:20pm (30 mins)

Technology Workshop

Virus Safety for Vaccines, Viral Vectors, and Cell Based Therapies

  • Damon Asher, Ph.D. - Head, Americas Vaccine Initiative, MilliporeSigma

11:50am 12:20pm (30 mins)

Technology Workshop

Meaningful Insights on Subvisible Particle Morphology, Size and Purity

Electron Microscopy (EM) together with image analysis give unmatched insight on sample purity, particle stability and morphological characteristics. This case study shows how a table-top MiniTEM system developed by Vironova is used to automatically detect undesired process outcome such as debris, broken particles and aggregates. Purity and integrity of AAV and Adenovirus gene therapy vectors samples are measured automatically in about one hour.

  • Mathieu Colomb-Delsuc, Ph.D. - Senior Scientist, Electron Microscopy Technologies, Vironova

11:50am 12:20pm (30 mins)

Technology Workshop

Cell Culture Perfusion Doesn’t Need to be Complicated

The demand for drugs and biosimilars is growing. The need to produce high concentrations of approved biotherapeutics in smaller and more flexible facilities has driven the development of increasingly sophisticated perfusion technologies. Furthermore, the advent of single-use products has accelerated production, minimized the risk of contamination, and requires less capital investment than traditional fed-batch culture. This technical workshop will discuss the challenges of developing and evaluating a perfusion process, and demonstrates how it can be successfully utilized as part of a single-use bioreactor system.

  • Yasser Kehail - Global Bioprocessing and Analytics Product Manager, GE Healthcare

11:50am 12:20pm (30 mins)

Technology Workshop

A Microfluidics-based Single Cell Isolation Workflow Optimized for Efficiency, Viability and Assurance of Monoclonality


Conventional techniques for single cell sorting and isolation, such as limiting dilution and flow cytometry, are significantly restricted by process inefficiencies including low plating densities, low viabilities, and limited assurance of monoclonality. Here, we present a workflow for highly efficient and viable, image-based, single cell sorting that simultaneously provides strong assurance of monoclonality.


  • Steve Wiltgen, Ph.D. - Product Manager, Molecular Devices, LLC

12:25pm 1:45pm (80 mins)

Main agenda

Understanding the Science Behind Liquid Leak and Microbial Ingress Mechanisms as the Foundation for Single Use Container Closure Integrity (SU-CCI) (Limited Seating)

This presentation describes a scientific approach to establishing a relation between liquid leak and microbial penetration mechanisms and developing the appropriate physical integrity testing methods and specifications.

  • Marc Hogreve - Senior Engineer Integrity Testing, Sartorius Stedim Biotech
  • Carole Langlois - Senior Product Manager, Fluid Management Technology, Sartorius Stedim Biotech FMT SAS
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech

12:25pm 1:45pm (80 mins)

Main agenda

From Screening to Small Scale GMP Biomanufacturing: Exploring a Simple, Unified Platform Strategy for Handling a Range of Cell Culture Needs (Limited Seating)

As the biopharmaceutical industry is evolving from mega-scale biomanufacturing toward efficient, smaller scale processes, familiar, lab-based incubation shakers represent an increasingly common strategy for meeting cell culture requirements from screening through small scale production. Learn how a single incubation shaker platform can handle 96 well plates for screening through validated production of as much as 16 total liters of culture.

  • Andrew Magno - Vice President, Sales and Marketing, and Manager Technical Services, Infors USA
  • Miles Scotcher, Ph.D. - Director, Business Development, ATUM

12:25pm 1:45pm (80 mins)

Main agenda

Luncheon & Roundtable Discussion: How to Increase Communication in the Industry and to Improve Sharing Regarding Lessons Learned for the Prevention and Reconciliation of Contamination Events

  • James Leung, Ph.D. - Senior Research Fellow, Massachusetts Institute of Technology

12:25pm 1:45pm (80 mins)

Main agenda

How to Find the Latest Research Tools and Technologies and Connect with Biomanufacturing Experts Worldwide


This presentation will show you how to find cutting-edge biomanufacturing tools and technologies and connect with global experts in cell culture, protein expression, process development, CMC, analytical, viral safety, formulation and other essential research areas.


  • Kevin Lustig, Ph.D. - CEO, Scientist.com

1:40pm 1:45pm (5 mins)

Viral Safety

Chairperson's Remarks

  • Michael Cunningham, Ph.D. - Associate Director, Applications, MSAT, MilliporeSigma

1:45pm 2:15pm (30 mins)

Viral Safety

Harmonization of Viral Segregation Strategy for Manufacturing Network with Multiple Facility Designs and Production Scales

Virus contamination of biologics may arise from contaminated raw materials as well as cross contamination of product intermediates, and risk mitigation such as appropriate viral segregation at manufacturing facilities is essential. With complex manufacturing networks that consist of multiple facility configurations and production scales, a harmonized viral segregation strategy that accounts for these differences is required to support network flexibility. Pre- and post-viral steps can be challenging to define as viral clearance is a continuum throughout the purification process and reliant on multiple process steps. Given diversity in facility designs and differences in the process step order and viral clearance claims, the development of a network strategy should focus on operational controls, procedural controls, and the demonstration of viral inactivation of cleanin g and sanitization. The presentation will focus on the development of the network-aligned viral segregation strategy at Roche/Genentech to defend viral segregation by the incorporation of regulatory requirements, feedback from across the manufacturing network, and risk-based touch-point analysis.

  • Bonnie Shum - Engineer II, Global Biologics Manufacturing Sciences and Technology (MSAT), Genentech, a member of the Roche Group

2:15pm 2:45pm (30 mins)

Viral Safety

Risk-reduction and Economic Considerations for Implementing Upstream Virus Filtration

Vaccines, viral vectors, and cell based therapies present special challenges for virus safety. Viral clearance approaches traditionally used in biopharmaceutical products, such as size exclusion or chemical inactivation, are often not useful when the product itself is a virus or a living cell. Considering lessons learned from the past, regulatory bodies and industry have striven to understand the risk associated with manufacturing of vaccines and novel therapies, and to implement barriers to potential viral contaminants. This presentation will examine application of virus safety principles to virus- and cell-based products. Selection of virus-free raw materials, safety testing of cell and virus stocks, and sensitive tests for detection of contaminating viruses during the manufacturing process are critical elements of a viral safety plan. Viral clearance steps may also be useful in some circumstances, such as the removal of helper viruses from viral vectors. These approaches can be combined to create comprehensive viral safety strategies that minimize the risk of viral contamination.

  • Michael Cunningham, Ph.D. - Associate Director, Applications, MSAT, MilliporeSigma

2:45pm 3:15pm (30 mins)

Viral Safety

Risk Mitigation Best Practices for Non-Animal Derived Materials used in Biologics Manufacturing

Viral contamination from upstream raw material components can wreak havoc on pharmaceutical manufacturing processes and ultimately affecting product quality and performance.  Biogen has taken a risk based approach to upstream raw material contamination by elimination of animal-derived raw materials wherever possible and by creating a risk assessment process animal contamination of raw materials.  In response to the identified higher risk raw materials, viral mitigation technologies have been outsourced to suppliers to enable Biogen to reduce viral contamination risk.

  • David Kolwyck, M.S., MBA - Director, Manufacturing Sciences, Biogen

1:40pm 1:45pm (5 mins)

Analytical & Quality

Chairperson's Remarks

  • Tariq Warsi, Ph.D. - Senior Scientist, Process Development, Amgen

1:45pm 2:15pm (30 mins)

Analytical & Quality

Phase-Appropriate Approaches to Streamlining Bioassay Testing

The Bioassay serves as a readout to verify the efficacy and potency of products destined for early phase studies. Currently, the industry uses a subset of methods to test for product potency, however these methods are technically complex and require extensive hand-on time to generate a result. A phase-appropriate approach has been implemented to ensure that methods used to determine potency are efficacious and robust, but also fit the new paradigm of expedited release testing. In addition to new methods used for potency analysis, the implementation of a unique automation approach to product potency assay execution using acoustic droplet ejection technology will ensure higher reliability and robustness in early phase testing.

  • Tariq Warsi, Ph.D. - Senior Scientist, Process Development, Amgen

2:15pm 2:45pm (30 mins)

Analytical & Quality

Evaluation of Differences in Potency in a Product with High Clinical Efficacy

  • Therese Choquette, Ph.D. - Fellow, Cell and Gene Bioanalytics, Novartis

2:45pm 3:15pm (30 mins)

Analytical & Quality

Late Breaking Presentation

1:40pm 1:45pm (5 mins)

Drug Product, Fill-Finish & Formulations

Chairperson's Remarks

  • Suresh Nulu - Senior Engineer II, Drug Product, Engineering and Technology Organization, Biogen Inc.

1:45pm 2:15pm (30 mins)

Drug Product, Fill-Finish & Formulations

Changing Development Paradigms Using Predictive Modeling in Drug Product Operations

In this talk, a compelling overview of how predictive models are used at various stages of Drug Product development and manufacturing in Biogen, will be highlighted. Case studies covering a wide range of applications in our Drug Product and device operations are presented, to show how modeling contributes to the scientific advancement, strategic objectives, and bottom line of our technical operations at Biogen. While the main focus is on mainstream applications of Computational Fluid Dynamics (CFD) modeling in the biopharmaceutical industry, non-traditional uses of CFD and other first-principles modeling techniques will also be presented here. Through this presentation, I intend to provide an inspiring perspective on the value of predictive models and advocate their increased adoption in the Biopharmaceutical industry.

  • Suresh Nulu - Senior Engineer II, Drug Product, Engineering and Technology Organization, Biogen Inc.

2:15pm 2:45pm (30 mins)

Drug Product, Fill-Finish & Formulations

Theoretical Models for Understanding Meniscus Behavior During Suck Back

  • Mark Palmer - Scientific Leader, PPE Device Engineering, R&D Platform Technology & Science, GlaxoSmithKline

2:45pm 3:15pm (30 mins)

Drug Product, Fill-Finish & Formulations

Quantify Pressure Distribution in the Filling Line - Pressure Analysis by In-Line Monitoring

Currently, there is no quantitative test method to analysis or collect pressure distribution data in parenteral drug product manufacturing equipment. The pressure applied to the containers during the manufacturing process could damage the integrity of the containers. This presentation will provide details of a new quantitative test method to monitor and quantify the pressure distribution in parenteral drug product manufacturing equipment.

  • Edwin Vilanova Velez - MSAT Engineer, Finished Goods, Genentech
  • Evan Justason - Chief Executive Officer, Smart Skin Technologies

1:40pm 1:45pm (5 mins)

Cell Culture & Upstream Processing / Manufacturing Strategy

Chairperson's Remarks

  • Nandu Deorkar, Ph.D. - Vice President, Research and Development, Avantor Performance Materials

1:45pm 2:15pm (30 mins)

Cell Culture & Upstream Processing / Manufacturing Strategy

Industry Initiative for Raw Material Risk Assessments

An industry-wide effort facilitated by BPOG is underway on raw material risk assessment. The goal is to leverage industry experience across multiple modalities, produce best practices and provide recommendations for lifecycle management of commonly occurring risks from raw materials. This effort will provide a guideline to facilitate risk assessment process, and build an industry consensus on value-added risk assessment approaches. The plan and current progress will be presented for industry peers’ input and comments.

  • Janeen Skutnik-Wilkinson - Director, Pfizer Limited
  • Chiali Liu, Ph.D. - Principal Scientist, Janssen Supply Chain
  • Duncan Low, Ph.D., Industry Consultant

2:15pm 2:45pm (30 mins)

Cell Culture & Upstream Processing / Manufacturing Strategy

Controlling Variability in Protein Therapeutics by Defining Trace Metal and Carbohydrate Composition in Upstream Process Development

The role of trace metals as cofactors with glycotransferases can be utilized to facilitate uniform carbohydrate attachment by understanding critical media concentrations and using defined media supplements. Here we report current efforts to limit variability by monitoring trace metal composition by using defined media and its resulting effects.  A novel approach to controlling protein heterogeneity using well characterized and defined media to support process development will be described.

  • Brian Beyer, Ph.D. - Global Director, Protein Sciences and Bioprocessing Applications, Avantor

2:45pm 3:15pm (30 mins)

Cell Culture & Upstream Processing / Manufacturing Strategy

Manufacturing Case Study in Raw Material and Storage Conditions

Although most biological production processes are moving towards using chemically defined media, the use of undefined raw material components is still a common practice in commercial processes. Not only is the undefined nature of raw materials a constant challenge to monitor process consistency, the handling and storage conditions of raw materials may also be a contributing factor to process and product variation. Due to the impact of variability in raw materials to process and product variation, this topic is still a continuous challenge encountered by commercial facility, such as Vacaville. Filter fouling during media filtration occurred during a commercial campaign of product “A”. The investigation identified a specific lot of hydrolysate as the suspected raw material causing the filter clogging. The suspected lot of hydrolysate met all specifications per the certificate of analysis and passed all the incoming release tests. Further investigation showed the fouling only occurred in certain packaging size. One of the differences between the different kit sizes was also their storage conditions. This presentation will focus on the use of small scale study to analyze raw material storage conditions of a hydrolysate component used. Work was performed to study the effect of storage conditions on the filterability of the component, to gain better understanding of the impact it may cause during media preparation.

  • Bunyada Kwong - Engineer II, Manufacturing Sciences, Cell Culture, Genentech

1:40pm 1:45pm (5 mins)

Recovery & Purification

Chairperson's Remarks

  • Natraj Ram, Ph.D. - Associate Director, Purifiaction, Manufacturing Sciences, AbbVie Inc.

2:15pm 2:45pm (30 mins)

Recovery & Purification

Removal of CHO Protein - Phospholipase B-Like 2 (PLBL2) during Downstream Processing of Monoclonal Antibodies

Effective removal of host cell proteins (HCPs) and impurities is necessary during mAb manufacturing produced in Chinese Hamster Ovary (CHO) cells. As such, most HCPs and impurities are cleared by rProtein A affinity chromatography, followed by one or two polishing steps in the standard downstream process. A specific HCP present in the cell culture, phospholipase B-like 2 (PLBL2), has been found to degrade a surfactant present in the drug substance formulation, and therefore, clearance during the downstream process is critical to ensure product stability. However, clearance of PLBL2 presents challenges due to a detectability issue using commercial HCP assay kits. We have studied PLBL2 (lipase enzyme) activities, challenges associated with its removal, and evaluated suitability of polishing chromatography during process development. In this presentation, we will d iscuss s imple ways of addressing clearance of PLBL2 during downstream processing of mAb products.

  • Ameya Borwankar - Scientist, PD-Downstream, Bristol-Myers Squibb

2:45pm 3:15pm (30 mins)

Recovery & Purification

Purification Process Development for a Light-Sensitive Monoclonal Antibody

Light exposure of biopharmaceuticals may lead to chemical and physical degradation by photooxidation of tryptophan, tyrosine, phenylalanine, and cysteine/cystine. An early photo-stability assessment demonstrated that a mAb had a rapid activity loss when the protein was exposed to white and ultra-violet light. This observation led to challenges for purification process development that included determining the mAb degradation rate in varying process intermediate conditions, determining light exposure control limits to minimize inactive mAb formation, and designing a polishing chromatography step to reduce inactive mAb, formed during processing, to acceptable levels. A photo-stability study of the mAb in process intermediates showed unacceptable degradation rates at room temperature. This result led to a decision to actively minimize light exposure to process material s during the manufacture of all development and clinical materials. Peptide analysis of the isolated inactive mAb revealed that activity loss was caused by the oxidation of two tryptophan residues present at the antigen binding region. Tryptophan oxidation could lead to a localized change is surface hydrophobicity for an impacted protein. This difference in local surface hydrophobicity between the mAb and the oxidized mAb was successfully exploited to separate the two variants using hydrophobic interaction chromatography. The optimized chromatography process delivered active mAb that met design process manufacturing goals for mAb purity and yield. In conclusion, a robust manufacturing process was successfully developed through understanding of protein degradation rates in process intermediates and by applying peptide-level characterization information to guide purification optimization strategy.

  • Nathaniel Macapagal - Scientist I, Purification Process Sciences, MedImmune

3:15pm 3:45pm (30 mins)

Main agenda

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

3:30pm 3:40pm (10 mins)

Main agenda

Welcome to Biotech Week Boston

  • Lauren Jones - Director of Business Strategy, Mayor's Office of Economic Development, City of Boston
  • Anna Chrisman - Managing Director, EBD Group and KNect365 Life Sciences

3:40pm 3:45pm (5 mins)

Main agenda

Chairperson’s Remarks

  • Charles Sardonini - Director of Process Engineering & Development, Sanofi

3:45pm 4:15pm (30 mins)

Main agenda

Improving Global Access to Biotherapeutics Through Molecule, Process and Manufacturing Design

This presentation will discuss the application of innovative technologies designed to expand global access to biotherapeutics. These integrated technologies will assist biotherapeutic discovery through the application of molecular design tools to improve candidate molecule developability, improve process design through intensification efforts, and reduce fixed costs associated with manufacturing facility construction and operation through the design of facilities with flexible, low cost features.

  • Dean Pettit, Ph.D. - Chief Scientific Officer and Founding Partner, Just Biotherapeutics

4:15pm 4:45pm (30 mins)

Main agenda

A Vision for Rare Disease: How We Can Champion Underserved Patients

Although each rare disease affects a relatively small number of patients, together they are one of the largest under-served patient populations in the world. To make sustained progress for rare disease patients, the biopharma industry must continue to innovate and embrace new technologies to drive advances that result in faster diagnosis, better access and more effective treatments.

  • Flemming Ornskov, M.D., M.P.H. - Chief Executive Officer, Shire

4:45pm 5:15pm (30 mins)

Main agenda

Synthetic Biology: Biomedical Applications Come of Age

Synthetic biology is bringing together engineers, physicists and biologists to model, design and construct biological circuits out of proteins, genes and other bits of DNA, and to use these circuits to rewire and reprogram organisms. These re-engineered organisms are going to change our lives in the coming years, leading to cheaper drugs, rapid diagnostic tests, and synthetic probiotics to treat infections and a range of complex diseases. In this talk, we highlight recent efforts to create synthetic gene networks and programmable cells, and discuss a variety of synthetic biology applications in biotechnology and biomedicine.

  • James Collins, Ph.D. - Termeer Professor of Medical Engineering & Science and Professor, Department of Biological Engineering, Massachusetts Institute of Technology

5:15pm 7:00pm (105 mins)

Main agenda

Opening Night “Celebration of Science in Boston” Reception in the Poster & Exhibit Hall

Kick off your conference experience at the Opening NightParty to celebrate the launch of Biotech Week Boston! Explore our “Celebration of Science” theme with a taste of molecular gastronomy from Boston’s celebrity chefs. Participate in several interactive activities and/or relax in one of the themed lounge areas. Enjoy a fun evening with food, drinks and entertainment.