Cambridge Healthtech Institute’s Inaugural
Manufacturing Efficiencies and Process Improvement
Harnessing Innovations to Deliver Higher Process Economics
Part of CHI's Ninth Annual The Bioprocessing Summit
August 23 - 24, 2017 | Westin Copley Place | Boston, MA

The global biopharmaceutical portfolio today reflects a shift toward more product diversity, expansion into personalized or targeted products, and an increase in orphan, breakthrough and biosimilar products designations. These trends, which may require smaller production runs and highly specific manufacturing requirements, are inspiring an evolution in technologies and processes to develop more efficient and cost-effective approaches for biopharmaceutical manufacturing.

CHI’s Inaugural Manufacturing Efficiencies and Process Improvement invites scientists to share and talk about their visions to bring higher efficiencies and better process economics for their product portfolio, including process improvements for recombinant proteins, and innovation technology solutions for new and emerging products, as well as creative facility planning using modular design and disposables technology.

Final Agenda

Wednesday, August 23

7:00 am Registration Open and Morning Coffee

8:05 Chairperson’s Opening Remarks

Chava Kimchi-Sarfaty, Ph.D., Research Chemist, Principal Investigator, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, FDA | CBER | OTAT

8:15 KEYNOTE PRESENTATION:

National Medical Countermeasure Response Infrastructure Overview

Joseph Figlio, Program Manager, Centers for Innovation in Advanced Development & Manufacturing [CIADM], Biomedical Advanced Research & Development Authority [BARDA], Office of the Assistant Secretary for Preparedness & Response [ASPR], U.S. Department of Health & Human Services

Timothy Belski, Joint Product Director, Medical Countermeasures Advanced Development & Manufacturing Capabilities [MCM-ADMC], Joint Project Manager for Medical Countermeasure Systems [JPM-MCS], Joint Program Executive Office for Chemical and Biological Defense [JPEO-CBD], U.S. Department of Defense

Over the last several years, the U.S. government has worked closely with the biopharmaceutical industry to establish a set of capabilities in order to address the nation’s needs for medical countermeasures. Working through these public-private partnerships, a core set of these capabilities leverage innovative equipment and infrastructure design to enable agile and flexible advanced development and manufacturing under cGMPs (e.g. multi-product biopharmaceutical facilities, mobile clean rooms, single use technology).

LEVERAGING INNOVATIONS IN EQUIPMENT, INFRASTRUCTURE AND FACILITIES

9:00 The Enterprise: Biomanufacturing’s Vehicle for Achieving Manufacturing Efficiency

Jeff Odum, CPIP, Global Technology Partner, Strategic Manufacturing Concept Group, NNE PharmaPlan

Creating strategic manufacturing assets for diverse product portfolios and new technology platforms requires development of an enterprise approach to biomanufacturing and optimization of the key enterprise elements. The key drivers of flexibility, agility, efficiency, and utilization have differing approaches within the enterprise model. This presentation will define the key elements of the approach and discuss case examples of attribute definition and risk-focused design execution.

9:30 Adaptable Facilities for Multiple Products with Varied Manufacturing Processes

David M. Marks, PE, President & Principal Consultant, DME

When asked in what aspect of GMP facility flexibility they value most, biopharmaceutical manufacturers consistently cite the ability to product multiple products with quick changeover, and the ability to easily adapt facilities to new products and manufacturing processes. Join this session to gain insights from DME's Facility Focus survey and learn how smart facility and process design integration supports high asset utilization while accommodating diverse product portfolios.

 10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Smart Design for an Efficient Facility with a Validated Disposable System

Jason Li, Vice President, Downstream Process & Technology Transfer, Genor Biopharma Co., Ltd.

Disposable systems have been proven to ensure efficient and flexible production of biologics. Both upstream and downstream processing case studies will be presented. In addition, the pros and cons for application of disposable as stainless steel systems will be compared in further detail.

11:15 Improving Efficiency, Evaluating Improvements: A Standardized Economic Cost Modeling Approach

Andrew Sinclair, Founder & President, Biopharm Services Ltd.

Rapid evaluation of technology options needs to be introduced early in product/process development, both for individual products and in development of improved manufacturing platforms. A foundation supporting such efforts is the use of economic analysis that allow the impact of a technology to be evaluated across a complete end-to-end platform process. This presentation evaluates the approaches and illustrates the potential of the standardized approach to look at those technologies that could impact on the next generation CHO MAb-production platform. It will focus on the potential or otherwise of the N-1 concentrated seed and potential of a novel Membrane Hydrogel Capture Step.

11:45 Poster Highlight:Streamlining and Standardizing Direct Material Change Assessments in Biopharmaceutical Manufacturing

Jia Liu, Ph.D., Scientist, Global Biologics MSAT, Genentech, Inc.

Understanding and controlling direct materials is essential to understanding and controlling variability in biopharmaceutical manufacturing.  Furthermore, Health Authorities require biopharmaceutical manufacturers to have oversight of the direct material suppliers and manage changes in compliance with cGMP.  When changes to direct materials by suppliers occur, careful assessment is required to ensure there is no impact to process performance or critical quality attributes.  Multiple departments are often required to collaborate on an assessment for a direct material change and the work load can quickly escalate considering the number of potential changes on hundreds of direct materials used in manufacturing.  This presentation summarizes the recent efforts made at Roche/Genentech to streamline the assessment procedure impacting the entire biologics manufacturing network of the company and standardize the requirements (testing, data, etc.) to support change approval.

12:15 Enjoy Lunch on Your Own

1:00 Session Break

ADAPTING PLATFORM STRATEGIES TO IMPROVE EFFICIENCIES FOR NEXT-GENERATION THERAPIES

1:45 Chairperson’s Remarks

Steven Cook, Head, Global Biologics Supply Operations, AstraZeneca

1:50 FEATURED PRESENTATION: Exosome Production: Limitations of the Current Toolbox and Strategies to Overcome Them

Michael Mercaldi, Ph.D., Director, Purification Process Development and Manufacturing, Codiak Biosciences

Exosomes have emerged as a therapeutic platform that could allow for the development of highly potent and directed therapeutics. The current state of exosome bioprocessing is limiting and will need to be improved to meet the potential future demands of these therapeutics. In this presentation, the potential of exosome-based therapeutics and the bioprocessing technologies for their future commercialization will be discussed in the context of the capabilities and limitations of the existing biomanufacturing platforms.

2:20 The Rewards and Risks of Using New Platform Technologies for Improved Therapeutic Protein Drugs

Chava Kimchi-Sarfaty, Ph.D., Research Chemist, Principal Investigator, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, FDA | CBER | OTAT

Recently approved recombinant protein therapeutics have been developed to treat patients with a wide variety of clinical indications, and the latest advances in protein engineering technologies have allowed drug developers and manufacturers to fine tune and exploit desirable functional characteristics of proteins of interest while maintaining product safety and/or efficacy. The talk will highlight the emerging trends and approaches in protein drug development using examples of therapeutic proteins approved by the U.S. FDA.

2:50 Challenges and Opportunities in Implementing Continuous/Semi-Continuous Downstream Processing

Lynn Conley, Biopharmaceutical Consultant

With cell culture titers and productivity increasing in the last decade, pressure is placed on downstream purification to look at alternative strategies to meet the demand of biotech products with high dose requirements. Even when the upstream process is not continuous (perfusion based), adopting a more productive continuous/semicontinuous downstream process can be of significant advantage. This presentation will review the various processing options for biomolecules and discuss the enabling technologies, its challenges and opportunities.

3:20 PANEL DISCUSSION: Developing and Manufacturing Next-Generation Therapies

Moderator:

Michael Mercaldi, Ph.D., Director, Purification Process Development and Manufacturing, Codiak Biosciences

Panelists:

Chava Kimchi-Sarfaty, Ph.D., Research Chemist, Principal Investigator, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, FDA | CBER | OTAT

Lynn Conley, Independent Consultant

• Limitations of current technologies
• How to select the proper regulatory pathway
• How to “break” out of the mAb toolbox
• Lifecycle development approach

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 PLENARY KEYNOTE PRESENTATION

6:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

Day 1 | Day 2 | Short Courses | Download Brochure

Thursday, August 24

8:00 am Registration Open and Morning Coffee

ACHIEVING EFFICIENCIES IN PROCESS DEVELOPMENT, SUPPLY CHAIN AND TECH TRANSFER

8:25 Chairperson’s Remarks

Lynn Conley, Biopharmaceutical Consultant

8:30 Achieving Operational Efficiencies in Biologics Manufacturing

Introduction - Key Factors Influencing Operational Technology Decisions 

Gloria Gadea-Lopez, Director, Shire

Part I: Advancing Continuous Processing Monitoring and Real-Time Analytics for Biologics Manufacturing

Robert Dimitri, Associate Director, Process Analytics, Shire

Part II: Scheduling and Optimization of Process Activities in Facilities with Disposables Technologies

John McGuire, Associate Director, Manufacturing Systems, Shire

Part III: Single Use Technologies Lifecycle With a Focus on Analytics

Mark Maselli, Senior Process Engineer, Production & Business Systems, Shire

9:30Process Development to Mitigate Supply Chain Risks

John Ward, Vice President, Engineering, Patheon

The planning process for launching a new product can be daunting for biologics companies. Critical factors such as inaccurate demand forecasts, process development variability and market timing must all be considered, making the supply chain planning process for biologic drug substance difficult at best. This presentation will evaluate some of the production options available as well as processes that will maximize an organization's ability to maintain flexibility on the path to commercialization.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 End-to-End Supply Chain Management for Complex, On-Demand Manufacturing and Distribution Networks

Steven Cook, Head, Global Biologics Supply Operations, AstraZeneca

Discussion will focus on the challenges of managing a dynamic global biologics supply chain and how to build in flexibility and manage agile delivery in a fast growing, new product introduction environment. Low volume, high value biologics are changing the healthcare landscape across the globe. New therapies bring uncertainty of demand and increasing pressures on manufacturing and supply chain to meet conflicting needs for speed, high customer service and costs.

11:15 Integrating Single-Use PAT Tools with Lean Manufacturing Principles at the Seed Stage - Challenges and Opportunities

Jose R. Vallejos, Ph.D., Manufacturing Cell Culture Scientist, Manufacturing Sciences & Technology, MedImmune

The potential benefits of implementing PAT tools at the seed stage (in a GMP environment) are lean manufacturing operations, reduced risks from bioburden/contamination, and mitigation of risks associated with tech/process transfer. Some challenges that can contribute to the slow implementation of PAT tools at the seed stage include a lack of understanding on how to go about implementing PAT tools, a lack of business strategy alignment between PD and Operations, and a lack of familiarity/understanding of the biotech industry needs and priorities.

11:45 Bridge Building: How to Manage Complex Technology Transfers

Jacob Jensen, Senior Manager, Global Program Management, Biogen Denmark

• What are the considerations required to ensure a smooth transfer of operations from R&D to manufacturing?
• Evaluation of critical aspects to ensure event-free manufacturing
• Discovering the importance of cross-functional communication and collaboration to promote successful routine biomanufacturing operations

12:15 pm Enjoy Lunch on Your Own

1:15 Dessert Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

1:55 Close of Conference