Before the Event
9 December 2018
Day 1
10 December 2018
  • 0700 - 1800
    Registration Open
  • 0830 - 1000
    Driving the Future of Advanced Biologic Therapeutics
    In this session learn how CBER is advancing the future of advanced therapies by taking active role in facilitating approval of advanced therapies, implementing various regulatory programs and publishing various guidances. Then discover how the future is now for one company and the technical operations that go into an approved product and beyond. After a short break, the session resumes with a view of the future of the human side of advanced biologic therapeutics.
    Session Leaders
    Principal
    Andre Walker Consulting
    [Greater Los Angeles Chapter Welcome ]
    Speaker: Justin Cantor
    || [Cell & Gene Therapy- The Future ]
    Speaker: Timothy Moore
    Cell therapy has shown a tremendous positive impact for patients and now that it is a proven effective therapy, what do we need to do to advance this therapy into the future?
    Speakers
    Placeholder Person Graphic
    Vice President - Operations
    PSC Biotech
    Executive Vice President, Technical Operations
    Kite, a Gilead Company
  • 1000 - 1045
    Networking Break in Expo Hall
  • 1045 - 1200
    Looking Toward the Future of Advanced Biologics Therapeutics
    In the continuation of the opening session, the session moves from the success of a practitioner with an approved therapy to a discussion on the future of the human side of the equation in manufacturing advanced biologics. Then join in the interactive panel discussion with all the session speakers where there will be time for questions and discussion.
    Session Leaders
    Principal
    Andre Walker Consulting
    [Challenges of Bringing a Facility Up to Production Scale – The Human Element]
    Speaker: Antonio Moreira, PhD
    Speakers
    Placeholder Person Graphic
    Deputy Director, Division of Cellular and Gene Therapies
    CBER/FDA
    Vice Provost, Academic Affairs
    University of Maryland, Baltimore County
    Executive Vice President, Technical Operations
    Kite, a Gilead Company
  • 1200 - 1315
    Networking Lunch in Expo Hall
  • 1315 - 1445
    Exploring the World of Oligonucleotides Commercialization - Part 1
    This session is all about oligonucleotides. Industry experts discuss a new facility design for manufacture of mRNA therapy and personalized vaccines which includes considerations for the changing paradigm of converting large volume facilities with mature technology to small, flexible multiple processing units, innovative new technologies, clinical and commercial batches in a single facility, flexibility in scale adjustment and miniature drug product batches, a discussion on the preparation and handling of the various solutions to support solid-support synthesis of oligonucleotides, and finally a glimpse into the new products of a oligonucleotide facility.
    Session Leaders
    Vice Provost, Academic Affairs
    University of Maryland, Baltimore County
    [Large Scale Oligonucleotide Synthesis ]
    Speaker: David Macdonald
    This presentation will focus on the preparation and handling of the various solutions to support solid-support synthesis of oligonucleotides. The design constraints of this type of facility are quite different that those of the typical biotech manufacturing plant. The high cost of feedstocks, purity requirements, and cross contamination concerns are all contributing factors to consider when designing the synthesis process and facility. These materials are typically solvent based, which adds increased complexity with regards to fire-safe handling and emergency venting. Best practices have been developed to ensure a safe, reliable, and cleanable system. Three points attendees will take away:
    1. Constraints which typically affect synthesis facility design
    2. Safety, code compliance, and property loss considerations
    3. Best practices for make-up and handling of solutions in a commercial process || [Factories of the Future to Factories of the Here and Now]
    Speaker: Indu Conley
    In response to the advent of innovative and advanced therapy medicinal orphan drug products, pioneering facilities must be designed and constructed to meet the manufacturing needs of these game changing orphan drug therapies. Technologies are evolving with the therapies, requiring flexible and creative thinking design teams to create leading edge facilities to manufacture these new medicines. We will discuss a new facility design for manufacture of mRNA therapy and personalized vaccines. The presentation considers the changing paradigm from large volume facilities with mature technology to small, flexible multiple processing units, innovative new technologies, clinical and commercial batches in a single facility, flexibility in scale adjustment and miniature drug product batches. We address additional challenges such as the overlap between biologics and small molecule chemistry with some of these ground-breaking medicines. The changing paradigm from large volume biologics to smaller innovative orphan drugs presents new challenges and opportunities for leading edge facility designs, implementing new and evolving technologies and addresses all the cGMP and regulatory challenges to achieve a “fit for flexible purpose, inspection ready” facility. || [Oligonucleotide Therapeutic Manufacturing]
    Speaker: Cory Siddons
    This presentation will provide an introduction to Alnylam, siRNA, and our clinical pipeline. I will discuss of delivery challenges with examples of advances in oligonucleotide therapies in the clinic and growing market places pressure on manufacturers (internal and CMO). There will be an overview of key challenges associated with olgo manufacturing – some aspects of biologics and small molecule API, along with a background of new state-of-art facility, and how Alnylam is preparing to meet the challenges ahead.
    Speakers
    Principal Engineer
    Hyde Engineering and Consulting
    Process Engineering Department Manager
    DPS Group
    Sr. Director, Manufacturing
    Alnylam Pharmaceuticals
  • 1315 - 1445
    Making Cell and Gene Therapy a Reality
    In this session, industry experts share experiences in facility design concepts for current generation gene therapy facilities, examine flexible facilities which allow easy repurposing of manufacturing spaces and designed for easy expansion as ATMP's become more industrialized or demand increases, and discuss the identification and subsequent control of process parameters to improve both the reproducibility and quality of the lentiviral vector in preparation for commercial production.
    Session Leaders
    Principal
    HDR Company LLC
    [Improved Process Control to Ensure Commercial Supply of LVV]
    Speaker: Michael Burns
    This presentation will discuss the identification and subsequent control of process parameters to improve both the reproducibility and quality of the lentiviral vector in preparation for commercial production. || [Building Capacity for Advanced Therapeutic Medicinal Products (ATMP)]
    Speaker: Ian Dacey
    || [Flexible Gene Therapy Facilities- Current Best Practices ]
    Speaker: John Dougherty
    Given the rapid increase in the number of companies with gene therapy products in the clinic and those transitioning through to commercial manufacture the demand for appropriately designed facilities is also increasing. As cell and gene therapy developers progress through the clinical trial phases to commercial manufacture, the strain on the production process increases, testing the limits of scalability and robustness. During these stages additional capacity may be required to transition through clinical trials and move to commercial manufacture, which may result in the need to move to a new facility or invest in a build program. Many companies have engaged in facility design projects to provide in house capability for late stage clinical and commercial launch facilities. The objectives of the presentation is to share experiences in facility design concepts for current generation gene therapy facilities based on a number of case studies from projects over the last 2 years.
    Speakers
    Scientist II, Vector Process Development Group
    BlueBird Bio
    Biopharma Specialist
    PM Group
    Lead Process Engineer
    DPS Group
  • 1445 - 1530
    Networking Break in Expo Hall
  • 1530 - 1700
    Exploring the World of Oligonucleotides Commercialization - Part 2
    In this session, learn how one company grappled with the "make versus buy" decision for their antisense oligonucleotides (ASO) supply. Hear about the challenges associated with internalizing a new manufacturing platform inside a biologics company, the project team's creative solutions, and focused execution that made it happen.
    Session Leaders
    Principal
    NCBioSource
    [Antisense Oligonucleotide Process Development and Validation: A Platform Strategy]
    Speaker: Stephen Errico, PE
    Biogen has a significant portfolio of antisense oligonucleotide (ASO) products in research and development. It is anticipated that 3-6 products will transition into development on an annual basis, and therefore, parallel product process development and validation activities will be required. Because of the projected workload, an innovative approach to process development and validation needs to be identified that leverages the science of ASO chemistry. Biogen is implementing a platform approach that leverages the unique characteristics of ASO chemistry; and emphasizes reaction chemistry and unit operation attributes of a product portfolio versus the typical product specific approach. The requirements of the platform approach will be presented. || [Launching Clinical Antisense Oligonucleotide Manufacturing Capability in a Biologics Company]
    Speaker: Paul Richards
    Biogen has historically been a protein therapeutic company, however in the last several years they have broadened their scope to include small molecules, antisense oligonucleotides, and gene therapies. Based on limited existing capacity in ASO manufacturing and Biogen’s growing ASO pipeline, the company made the decision to internalize the capability to supply ASOs for their clinical and commercial products. There were many challenges associated with internalizing a new manufacturing platform inside a biologics company, which required creative solutions by the project team and focused execution. By vertically integrating their ASO supply chain, Biogen has been able to significantly reduce turnaround time and reduce supply risk. || [Oligo Facility Design Challenges]
    Speakers: William Jarvis and Isaiah Cedillo
    Speakers
    Director, Manufacturing & Operations
    Ionis Pharmaceuticals
    ASO Portfolio Management Lead
    Biogen Inc.
    Principal, Global Process Engineering
    Biogen Inc.
    Placeholder Person Graphic
    Chief Chemical Engineer
    CRB
  • 1530 - 1700
    Case Studies in Cell and Gene Therapy Production
    Modular Facility Design continues at the forefront of new construction techniques. This session will present case studies of facility prototypes that leverage new ways of integrating modular systems to their fullest. In addition to modular facilities, this session will also include a discussion on implementation of adaptive modular and mobile cleanrooms / bioproduction facilities. Rounding out the session is a case study on validation and control strategy for cell and gene therapy products.
    Session Leaders
    President
    Arencibia Quality Compliance Associates, LLC
    [Considerations in Cell Therapy Process Validation and Control Strategies]
    Speaker: Rachel Yost
    Additional considerations are required for process control strategies and process validation of cell therapy products, due to the autologous nature of the incoming raw material resulting in high variability and shortened development timelines. We will walk through some of the unique challenges presented during process validation and application of validation guidelines for a cell therapy product. || [Modular Platform Delivery Considerations for Today’s New Drug Production Facilities]
    Speaker: Peter Cramer
    Modular Facility Design and standardization initiatives continues to be at the forefront of new construction techniques aimed at reducing cost and schedule while keeping quality high. This presentation will cover four (4) recent case studies of facility prototypes that leverage new ways of integrating modular systems to their fullest. Prototype designs include:
    -Single Use Biotech / Drug Substance
    -Cell & Gene Therapy
    -Antibody Drug Conjugate
    -Fill Finish / Drug Product
    Biopharma wants to make new drug products more accessible and at the same time be able to quickly respond to changes in the way new drugs are produced and the variations in product demand. The industry is challenged to deliver truly flexible biopharmaceutical manufacturing facilities with significant reductions in schedule, cost, and client operating resources.
    To achieve these goals, design firms in the Life Sciences market are now capturing many of their best practices for flexible manufacturing into a prototype facility design where modular and other pre-engineered systems can be evaluated for use on a project. The platform-modular approach along with a set of analysis tools allows life science companies to rapidly ascertain the economic advantage of using a prototype design and the degree to which modular and pre-engineered systems can be leverage to reduce cost and schedule while retaining the overall quality they need.
    This presentation will show recent modular prototype designed and the platform design approach that was used to create them. These prototypes demonstrate how companies can leverage the best systems the modular market now has to offer. || [Implementing Adaptive Modular and Mobile Cleanrooms / Bioproduction Facilities: A Case Study]
    Speaker: Jeff Serle
    Jeff Serle, Senior Vice President of Germfree, will lead you through the technical and engineering challenges associated with the development and implementation of adaptive modular and mobile cleanrooms / bioproduction facilities. Using lessons learned from designing, engineering and installing a mobile facility for clinical vaccine production, Mr. Serle will offer a clear look into why mobile cGMP production space is necessary now and how this advanced technology will impact flexible facility design in the future.
    Speakers
    Process Engineer III
    Juno Therapeutics Inc
    VP, Life Sciences Facility Design
    Exyte
    Senior Vice President
    Germfree Laboratories, Inc.
  • 1700 - 1800
    Networking Reception in Expo Hall
Day 2
11 December 2018
  • 0630 - 1730
    Registration Open
  • 0700 - 0830
    Women in Pharma Round Table Discussions
    “Define success on your own terms, achieve it by your own rules, and build a life you’re proud to live.” – Anne Sweeney (President of Disney Channel).  Being a woman in the corporate environment is full of challenges, from equal pay to glass ceilings; our achievements have been hard fought.  Understanding the journey of those that have achieved success while considering the current issues and opportunities for women in the corporate workplace today is essential for future leaders in the life sciences.   Please join us and our panel of extraordinary women industry leaders, as we discuss how to stay engaged in your career, manage conflicting personal and professional priorities, communicate effectively in a multicultural/multigenerational workforce, and gain insight into their recipe for success in an ever-changing corporate environment.
    Session Leaders
    Sr. Program Manager, Validation
    Pharmatech Associates, Inc.
    President
    Arencibia Quality Compliance Associates, LLC
    Speakers
    Principal Scientist, Process Development
    Amgen Inc
    Senior Director, Pharmacovigilance CAPA Center of Excellence
    Johnson & Johnson
    Sr. Director, Corporate Security and Crisis Management
    Gilead Sciences Inc
    Site Director, Quality Management
    Shire
    Associate Director, Asset Quality Lifecycle
    BioMarin Pharmaceutical Inc.
    Senior Director Facilities Engineering
    Gilead Sciences, Inc.
  • 0845 - 1015
    Regulatory Challenges of Highly Technical Products
    Challenges associated with Advanced Therapy Medicinal Products (ATMP) development include the complex scientific and manufacturing aspects, as well as a dynamic, complex and rapidly advancing regulatory environment. This session provides both a regulatory and industry perspective on these challenges.
    Session Leaders
    VP Global Ops Learning and Development
    AstraZeneca
    [Case Study of Regulatory Changes in Oncology Biologic-Biologic Combination Studies ]
    Speaker: Jennifer Eck
    || [Regulatory Developments for Advanced Therapy Medicinal Products (ATMP)]
    Speaker: Darren Dasburg
    Speakers
    Placeholder Person Graphic
    Associate Director, Regulatory Affairs CMC
    MedImmune
    Placeholder Person Graphic
    Deputy Director, Division of Cellular and Gene Therapies
    CBER/FDA
    VP Global Ops Learning and Development
    AstraZeneca
  • 1015 - 1100
    Networking Break in Expo Hall
  • 1100 - 1230
    Process Development for New Technologies
    Academic R&D centers play a critical role as fountains of knowledge and creative innovations that lead to the availability of new or improved healthcare options for patients around the globe. This session will highlight initiatives from three universities that are leaders in the development of advanced biopharma manufacturing technologies and processes. The first presentation will discuss disruptive innovations that will shift the paradigm for biologics manufacturing and bring "Biologics on the Go" close to reality. It will be followed by a presentation on using integrated omics for bioprocess improvement and optimization. The final presentation will highlight how data from clinical trial subjects receiving autologous T cell therapy products can be used back in the process development stage for these products.
    Session Leaders
    Vice Provost, Academic Affairs
    University of Maryland, Baltimore County
    [Integrative Omics in Biotechnology]
    Speaker: Junyoung Park, PhD
    Advanced bioproduct synthesis requires coordinating cellular resources and overcoming unfavorable native regulations. We solve these metabolic engineering challenges by modularizing the bioprocesses and optimizing each module using integrative metabolomic-fluxomic insights. Using this workflow, which can be generalized to other processes, we demonstrate accelerated conversion of carbons in their most oxidized, undesirable state (CO2) to the most energy-dense state (lipids). || [Predictive Correlates of Response to CAR T Cell Therapy]
    Speaker: January Salas-McKee, PhD
    || [Disruptive Innovations for Advancing Biomanufacturing]
    Speaker: Antonio Moreira, PhD & Govind Rao, PhD
    Despite breathtaking advances in cell and molecular biology, the actual technology for culturing cells is little changed from its inception. If Louis Pasteur were to travel forward in time, he would find himself easily able to pick right up where he left off in terms of the technology used for sterile cell culture. To this day, even the most advanced cell-therapy applications essentially use serial batch culture in sterile vessels/media. Although there have been impressive advances in robotic handling, computer control of incubators etc. the actual physiological state of the culture remains a black box. We will present several case studies where we demonstrate how critical parameters such as oxygen, CO2, glucose and glutamine can be readily monitored in real-time and provide a great deal of insight into culture conditions and cell physiology. Examples of sensors that can range from minimally to completely non-invasive and easily integrated into culture vessels will be presented. By “fingerprinting” these critical process parameter profiles, one can use the tools of machine learning and AI to lead to much more consistent manufacturing of cell and gene therapy products.
    Speakers
    Assistant Professor, Chemical and Biomolecular Engineering
    UCLA
    Placeholder Person Graphic
    Clinical Cell and Vaccine Production Facility
    Perelman School of Medicine, UPENN
    Vice Provost, Academic Affairs
    University of Maryland, Baltimore County
  • 1100 - 1230
    Principles of the Design, Qualification, and Operation of a Gene Therapy Facility
    Gene Therapy is a growing sector of the Pharmaceutical industry when it comes to fighting or curing rare diseases. This therapy has many advantages including providing a patient who is born with or who develops a genetic disease with normal genes and a chance at a healthier life. However, it is important to understand how the facility is designed, challenges in the Commissioning and Qualification, as well as tips of how to operate this type of a facility to ensure that product leaving the facility consistently remains compliant and employees always operate in a safe work environment. During this session, we will review the unique design and operational characteristics of a gene therapy facility designed to be compliant with the EU, Health Canada, and FDA regulations. Also, we will discuss the challenges of commissioning and qualifying the facility as well as the applicability of an ASTME2500 approach to a streamlined start-up.
    Session Leaders
    Sr. Program Manager, Validation
    Pharmatech Associates, Inc.
    [Understanding Design Decisions to Operate and Support a Gene Therapy Facility]
    Speaker: Stacey Cox
    || [Principles of the Design, Qualification, and Operation of a Gene Therapy Facility]
    Speaker: Lisa Rappl
    || [Unique in More Ways than One: Commissioning & Qualification of a Gene Therapy Facility ]
    Speaker: Moria Feighery-Ross
    We discuss the unique challenges and opportunities provided by commissioning and qualifying manufacturing facilities for gene therapy products. Short timelines and long equipment lists add challenge and complexity, but understanding the most commonly used production and utility equipment, and utilizing a family approach and a practical understanding of the particular requirements for the target product can smooth out the bumps in the road.
    Speakers
    Placeholder Person Graphic
    Senior Manager, Automation Engineering
    BioMarin Pharmaceutical Inc.
    Associate Director, Asset Quality Lifecycle
    BioMarin Pharmaceutical Inc.
    Project Manager
    Pharmatech Associates, Inc.
  • 1230 - 1330
    Networking Lunch in Expo Hall
  • 1330 - 1500
    Cell and Gene Therapy Lab to GMP Production Workshop, Part 1
    In this two-part workshop session, participants will understand how a lab scale cell therapy process can be scaled-up to cGMP manufacturing. Participants will break into small groups of and each group will be given product information, a lab scale process description, and a volume of dose per year for cGMP product production. Each team will create the identified high-level deliverables that are typically required from a user requirements perspective. A short presentation will be given by the session leaders on each topic before the teams break-out to work on the deliverables. Each team will then present to the group what they have developed. Whole group discussions will be encouraged. Part 1 is all about the Process Flow Diagram (PFD)
    Session Leaders
    Principal
    NCBioSource
    [Process Flow Diagram (PFD) ]
    Speaker: Daniel Pratt
    Speakers
    Principal
    Andre Walker Consulting
    Technology Manager Biotechnology
    CRB Group
    Principal
    NCBioSource
    Director Engineering and PM
    Takeda Pharmaceutical International Co.
    USA Managing Partner
    Laporte Consultants
  • 1330 - 1500
    ADC Manufacturing: Current Challenges - Future Possibilities
    This session is all about ADCs and leads off with a discussion about the unique challenges of developing suitable analytical methods to characterize ADCs due to changes in the physicochemical properties of the antibody with payload attachment. Then we look to the containment and personnel protection requirements for the cytotoxic payloads of ADCs as well as cleaning and cross contamination limits. The session closes with a discussion on implementation of a continuous conjugation process. Learn how one company is working to achieve a single-pass purification process with a flow chemistry conjugation reaction as an important step toward continuous ADC processing.
    Session Leaders
    Principal
    HDR Company LLC
    [Continuous Processes for Antibody-Drug Conjugate (ADC) Manufacturing]
    Speaker: Robert Herbst, PhD
    We will discuss the efforts that have been taken at ImmunoGen to implement continuous conjugation processes. We have focused our efforts on two areas which include investigation of continuous conjugation reaction chemistry using principles adapted from the field of flow chemistry. Second, we have implemented novel technologies to enable continuous purification of ADCs following conjugation. Ultimately, coupling both efforts together, a single-pass purification process with a flow chemistry conjugation reaction, would be an important step toward realizing continuous ADC processes in a manufacturing setting. || [Preventing Cross Contamination with high potent ADCs ]
    Speakers: Richard Denk
    Containment Requirements for ADCs and how to fulfil GMP and Operator Protecting during manufacturing Requirements for Cleaning and Cross Contamination Limits in aseptic processing in shared facilities. Facility designs for new modalities emerging from research will present different challenges than typical mAb facilities. Process intensification continues to move mAb manufacturing towards fully continuous biologics manufacturing with a resulting dramatic change in facility size, cost, and operating paradigms. Antibody Drug Conjugates and Oligonucleotide manufacturing introduce potent compound and solvent management challenges that may be unfamiliar to typical large molecule staff. || [Preventing Cross Contamination with High Potent ADCs ]
    Speaker: Richard Denk
    || [Analytical Strategies for the Characterization of Antibody-drug Conjugates (ADCs)]
    Speaker: Alex Lazar, PhD
    During the presentation, several physicochemical analytical methods for ADCs will be presented and the particularities of the methods will be highlighted.
    Speakers
    Placeholder Person Graphic
    Director, Process Development
    ImmunoGen Inc
    Head, Sales Containment
    SKAN AG
    Head, Sales Containment
    SKAN AG
    Director, Analytical & Pharmaceutical Sciences
    ImmunoGen Inc
  • 1500 - 1545
    Networking Break in Expo Hall
  • 1545 - 1715
    Cancer Vaccines: From Development to Commercialization
    Genomic sequencing and bioinformatics understanding are key to development of mRNA-based personalized cancer vaccines (PCVs). These custom-tailored vaccines are designed based on each patient's particular tumor mutations (neoantigens), with the goal of inducing high-affinity immune T-cell responses against cancer.

    DNA is extracted from an individual patient's tumor cells and sequenced. By comparing the sequences of the patient's tumor mutations with germline DNA from normal cells, tumor mutations are identified.

    Then, using proprietary algorithms that evaluate the immunogenic potential of the tumor mutations in the context of the patient's HLA type, the neoantigens most likely to elicit an immune response are selected and incorporated into a vaccine.

    This truly personalized medicine akin to cell and gene therapy presents unique challenges and opportunities in the CMC CGMP environment. This session will explore how one patient one batch concepts are adapted in the clinical stage and what that looks like advancing into the commercial stage.
    Session Leaders
    Vice President, Global Quality Compliance and External Relations
    Genentech, Inc.
    [Regulatory CMC Aspects of Cancer Vaccine Production ]
    Speaker: Ingrid Markovic, PhD
    Personalized Cancer Vaccines (PCV) is a rapidly advancing field that incorporates several innovative technologies. These individualized therapeutics offer great promise as patient-specific immunotherapies targeting tumor antigens. There are unique aspects of the manufacture and control of PCV, as well as requirements for cGMPs, compared to traditional biologics. In this regard, they are regulated as gene therapy products and subject to traditional biologic regulations (21 CFR 600s) to assure quality, safety and efficacy, which is paramount. This presentation will provide an overview of PCV manufacture and control in the context of the evolving regulatory landscape. || [GMP for Vaccine Manufacturing]
    Speaker: Paul Foley
    Speakers
    Placeholder Person Graphic
    Senior Director, US Pharma Technical Regulatory
    Genentech Inc
    Placeholder Person Graphic
    Ad Interim, Head Investigational Medicine Products, Quality
    Genentech Inc
  • 1545 - 1715
    Cell and Gene Therapy Lab To GMP Production Workshop, Part 2
    In this continuation of the workshop, participants will meet again in their groups following short presentations on two topics: The Equipment List and the Facility Layout.
    Session Leaders
    Principal
    NCBioSource
    [Equipment List Presentation]
    Speaker: Emilie Pelletier
    Speakers
    Principal
    Andre Walker Consulting
    Technology Manager Biotechnology
    CRB Group
    Principal
    NCBioSource
    USA Managing Partner
    Laporte Consultants
Day 3
12 December 2018
  • 0700 - 1300
    Registration Open
  • 0800 - 1045
    Advances in Continuous Biologics Manufacturing
    In the growing biologics industry, biopharmaceutical companies continue to evaluate continuous processing to improve efficiencies. This session begins with an overview of the FDA perspective on continuous biologics manufacturing followed by an industry perspective of Quality oversight for biologics. After a short break, the session continues into a more technical discussion. Experts will discuss technologies that move continuous bioprocessing farther downstream, paving the way for an end to end continuous process.
    Session Leaders
    Principal
    Andre Walker Consulting
    [A New Quality Oversight Paradigm for the Manufactoring of Biological Products ]
    Speaker: Juan Torres
    Modern analytical technologies are redefining the way that the quality of biological products is assured. Currently, main quality checks rely heavily on the consistent execution of a validated process and conformance to prescribed testing of either the drug substance or drug product, supplemented by discreet in-process testing. Progress in advanced process controls, novel analytical technologies, real-time measurements, and effective management of large data sets offer new possibilities for how the oversight of quality control can be executed. This oversight can shift from a heavy reliance on end-process testing to an integrated approach that allows for faster product release and dynamically adjust to normal process variability to accurately assess impact or adjust. This presentation will discuss how these approaches can be practically and effectively integrated into a process resulting in a better assurance of quality along with a more efficient system. || [Technical Capability of Raman Spectroscopy for In-line Quantification of Antibody Product Quality]
    Speaker: Gordon Magill
    Recent years have shown an increase in the development and application of Raman spectroscopy for process monitoring and control in the biopharmaceutical industry. While Raman spectroscopy has been successfully used to predict cell densities and concentrations of conventional metabolites, limited work has been presented on its capability to measure product related attributes, including titer and product quality variants. Here, we present results using Raman spectroscopy to obtain online measurements of CHO antibody charge, size, and glycosylation variants across a range of antibodies and antibody derived molecular formats. In addition, we discuss the technical challenges in deriving these measurements using multivariate analysis techniques. || [Regulatory Perspective on Continuous Manufacturing for Biologics]
    Speaker: Patricia Hughes, PhD
    || [Industry 4.0 and Continuous Manufacturing]
    Speaker: Samet S. Yildirim
    This talk will address why integrated continuous manufacturing is essential to move into the Industry 4.0 and how we can utilize digital technologies in biopharma manufacturing. Questions explored include: What industrial revolution are we currently in? Why disposable, integrated and continuous process is essential for industry 4.0? Highly automated and modular flexible facilities are the future of biomanufacturing. Knowledge management, machine learning and big data are essential parts of the game. How can 3D printing be part of disposable processes? || [MultiColumn Chromatography: A Step Towards Continuous Manufacturing]
    Speaker: Rickey Lu
    Though continuous manufacturing of biologics represents a major step change in the industry, it need not be taken in one giant leap. Many challenges and questions arise when moving from platform technologies to another including what to do with the installed capital, ensuring technical success and the implications on new product launch timelines of additional regulatory questions. In this talk, we will explore an approach to initiating the transition to continuous manufacturing through a discussion of the technical and business benefits of multicolumn chromatography. Multicolumn chromatography presents an opportunity to develop and implement a technology that enables continuous manufacturing while providing near term benefits. These benefits create a standalone business case that does not require the promise of continuous manufacturing. This stepwise approach to the implementation of continuous-enabling unit operations provides companies the ability to develop expertise and comfort with new unit operations while buying down risk.
    Speakers
    Senior Vice President, Global Quality
    Biogen
    Engineer II
    Genentech Inc
    Branch Chief, Division of Microbiology Assessment
    FDA
    Technology Innovation Manager
    Boehringer Ingelheim
    Director Manufacturing Technology & Innovation
    AstraZeneca
  • 0925 - 0940
    Networking Break
  • 1045 - 1200
    Industry and Regulatory Panel Discussion
    What are the opportunities and hurdles to implementing new and/or "disruptive" technologies in the production of legacy products or production new products with existing technologies? This panel discussion explores the challenges for industry and regulators alike and gives attendees the opportunity to ask their most pressing questions.
    Session Leaders
    Vice President, Global Quality Compliance and External Relations
    Genentech, Inc.
    [Regulatory Perspective on Continuous Manufacturing for Biologics]
    Speaker: Patricia Hughes, PhD
    Speakers
    Placeholder Person Graphic
    Senior Director, US Pharma Technical Regulatory
    Genentech Inc
    Senior Vice President, Global Quality
    Biogen
    US FDA, Invited
    Branch Chief, Division of Microbiology Assessment
    FDA

IMIS Description Character Cleanup