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Key Sessions

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

Presentation Title TBA

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

8:00am 8:15am (15 mins)

Viral Safety

Chairperson's Opening Remarks

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)

Viral Safety

Late Breaking

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

Main agenda

Breakfast Networking & Discussion: 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, Ph.D. - Professor and Department Head, Chemical Engineering, The Pennsylvania State University

8:00am 8:15am (15 mins)

Analytical & Quality

Chairperson's Opening Remarks

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

8:00am 8:15am (15 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

8:00am 8:15am (15 mins)

Recovery & Purification

Chairperson's Opening Remarks

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

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

8:00am 8:15am (15 mins)

Manufacturing Strategy

Chairperson's Opening Remarks

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.

  • Stephen Hudd - Senior Director, Global Process Engineering, 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

8:00am 8:15am (15 mins)

Cell Culture & Upstream Processing

Chairperson's Opening Remarks

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

Cell Culture & Upstream Processing

Case Study of Custom Production Medium Development in Collaboration Between Eisai 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 to have ro bust 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, Genetech, 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

Improving Antibody Titers Through Media and Process Improvements, While Maintaining Product Quality Attributes

Rounds of DOE study have led to the selection of the prototype of medium, including basal, feed and feed supplement.  Protein production has improved at bench scales through extensive process optimization, while product quality attributions remains.

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

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

9:00am 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

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

Main agenda

Networking Refreshment Break

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

10:10am 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

  • 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

  • Aurora Henry - Raw Materials Specialist, CMC Biologics

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

Viral Safety / Recovery & Purification

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 Nogueras - Senior Associate Scientist, Amgen

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

Analytical & Quality

Chairperson's Remarks

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

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, 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

Late Breaking Presentation

10:45am 11:15am (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

11:15am 11:45am (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

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

Cell Culture & Upstream Processing

Chairperson's Remarks

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

On Demand Nutrient Feed During Automated Cell Culture Process

  • Robert Bearish, Ph.D. - Scientist, Zoetis

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

Cell Culture & Upstream Processing

Late Breaking Presentation

  • 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

  • Anthony Hawrylechko - Director of Microbial Bioprocess, Cytovance Biologics

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

Technology Workshop

Extractable Test Results from a Monolayer, Fluoropolymer Single-Use Bag Utilizing the BPOG Extractable Protocol

The materials of construction of single-use components and systems continue to be a concern with regard to extractables and their impact on process fluids.  This presentation will share extractable data generated using the BPOG protocol on a monolayer, fluoropolymer bag material that is void of any additives such as adhesives, plasticizers, lubricants or antioxidants.

  • 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 is Less Complicated than Perceived

  • Yasser Kehail - Upstream Bioprocessing Applications Specialist, GE Healthcare

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

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

  • Stacy Springs, Ph.D. - Director, Biomanufacturing Program, Executive Director, Consortium on Adventitious Agent Contamination in Biomanufacturing, MIT Center for Biomedical Innovation

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

  • Bonnie Shum, Ph.D. - 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

  • 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

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

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

Analytical & Quality

Chairperson's Remarks

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

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, 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

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

Recovery & Purification

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

  • Mukesh Mayani, Ph.D. - Scientist II (Process Development), Biologics Process Development, 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

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

Main agenda

Chairperson’s Remarks

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

Presentation Title TBA

  • 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 Cocktail Reception in the BWB Exhibit & Poster 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.