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8 am 9 am (60 mins)

Main agenda

Coffee & Registration

9 am 9:15 am (15 mins)

Continuous Processing Symposium

Chairman’s Opening Remarks

  • Peter Levison, Ph.D. - Senior Marketing Director, Downstream Processing, Pall Life Sciences

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

Continuous Processing Symposium

Perspectives on Continuous Processing

  • Howard Levine, Ph.D. - Founder, President and Principal Consultant, BioProcess Technology Consultants

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

Continuous Processing Symposium

Pilot-Scale Perfusion and Clarification Using Multidimensional Acoustic Wave Perfusion Device

By utilizing continuous processing for therapeutic proteins manufacturers can realize significant advantages in product quality, facility footprint and capital expenditure. Intensified perfusion is a popular modality for upstream portion of a continuous processing which often leverages a membrane based cell retention device. While membranes offer complete cell retention, they often have a limited effective lifetime and potential product retention which may requires aseptic device replacement, variable product residence time and decreased product mass flow to downstream processes. By employing a prototype, high performance multidimensional acoustic wave perfusion device as a replacement for membrane based cell retention, a continuous process could operate with decreased cell retention device replacement, consistent product residence time and high product delivery to downstream processing. Acoustic cell retention devices allow small amounts of cells and cell debris to exit the bioreactor with the product of interest, thus requiring aseptic clarification prior to product capture within an integrated continuous process. In this work, we aim to leverage our bench scale experience with this prototype cell separation device to processes at larger scales in order to enable integration with parallel continuous processing efforts.

  • William Napoli - Scientist, Bioprocess Technology and Expression, BioProcess Development, Merck & Co., Inc.

9 am 5 pm (480 mins)

Vaccine Development and Production: Novel Technologies and Strategies

Vaccine Development and Production: Novel Technologies and Strategies

This symposium will provide a comprehensive update on vaccine process development and manufacturing strategies throughout the product lifecycle. Case studies and technology implementations in upstream, downstream and analytical development to improve efficiency in vaccine manufacturing will be discussed.  

Confirmed Speakers:

Overview of Current Drivers of Vaccine Manufacturing Development from Facility, Technological, Regulatory and Analytical Perspectives

Joshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc.

Bio-Analytical Comparability: Strategy for Implementing Process Changes, and Approval of New Manufacturing Facility 

We have developed a Bio-Comparability strategy based on the state of the art analytical techniques for implementation of process changes at scale or manufacturing site; and also licensing new manufacturing facility. I will present implementation of vector optimization for yield improvement, and also licensure of a new manufacturing facility for the production of Flublok.

Indresh Srivastava, Ph.D., Vice President, Process & Analytical Development, Senior Program Manager – Influenza, Protein Sciences Corporation

Vaccine Delivery and Device Innovation 

Darin Zehrung, Senior Technical Officer & Portfolio Leader, Vaccine and Pharmaceutical Delivery Technologies, PATH

Manufacturing Investigations for Vaccines

Brian Meyer, Ph.D., Principal Scientist, Vaccine Drug Product Development, Merck

Panel Discussion: The Future of Vaccine Antigen Manufacturing

Mario Barro, Ph.D., Senior Director, Innovation, Sanofi Pasteur

Indresh Srivastava, Ph.D., Vice President, Process & Analytical Development, Senior Program Manager – Influenza, Protein Sciences Corporation

Panel Discussion: Global Health Vaccine Manufacturing Challenges: Innovation to Support Reduced Cost of Goods

Subhash Kapre, Ph.D., CEO, Inventprise

Peter Latham, Ph.D., President and Managing Partner, Latham Biopharm Group

Presentation Title TBA

Lynne A. Isopi, Principal Scientist, Merck

  • Joshua Speidel, Ph.D. - Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMP
  • Indresh Srivastava, Ph.D. - Vice President, Process & Analytical Development, Senior Program Manager - Influenza, Protein Sciences Corporation
  • Darin Zehrung - Senior Technical Officer & Portfolio Leader, Vaccine and Pharmaceutical Delivery Technologies, PATH
  • Brian Meyer, Ph.D. - Principal Scientist in New Technologies, Vaccine Drug Product Development, Bioprocess Research and Development, Merck Research Laboratories
  • Mario Barro, Ph.D. - Senior Director, Innovation, Sanofi Pasteur
  • Subhash Kapre, Ph.D. - CEO, Inventprise LLC
  • Peter Latham - President and Managing Partner, Latham BioPharm Group, Inc., PgMP
  • Lynne Isopi - Principal Scientist, Vaccine Drug Product Development, Merck

9 am 5 pm (480 mins)

Biosimilar Development and Production

Biosimilar Development and Production

The development, manufacturing and commercialization of biosimilars has become a much more complex endeavor than originally anticipated by many companies. Regulatory expectations for biosimilars in terms of characterization, biosimilarity, comparability, clinical studies, biological assays and more have resulted in a renewed emphasis on developing efficient processes and strategies to accelerate development. This multi-speaker workshop will provide an overview of biosimilars, and may include presentations on best practices, case studies, regulatory perspectives and lessons learned from current biosimilar development programs.

Confirmed Presentations:

Strategies for a Successful Biosimilar Product Development

Sadettin Ozturk, SVP, Process and Analytical Development, MassBiologics, USA

The field of biosimilars or “follow-on biologics” is active, in an effort to make biologics more affordable and more accessible. Several products are already approved and there are many products in development around the globe. While developing, a biosimilar product seems to be easier and cheaper than the original product; demonstrating comparability, addressing regulatory issues, and uncertainties about the future, pose significant hurdles to companies hoping to bring biosimilars to market. Expertise in biological product development, ability to link process conditions to product attributes, strong analytical skills, and clear clinical and regulatory strategies are critical to the success of biosimilar product development. This talk will present challenges and opportunities in the field and provide strategies for successful development of biosimilars.

  • Sadettin Ozturk, Ph.D. - SVP, Process and Analytical Development, MassBiologics

9 am 5 pm (480 mins)

Modern CMC Regulatory Strategies and Insights

Modern CMC Regulatory Strategies and Insights – from Concept to Approval

On average, it still takes in excess of 10 years to develop a new biopharmaceutical drug product. It is estimated that the cost of developing a new biopharmaceutical drug product, and taking into account the > 90% failure rate, is over $2 billion. Conscious of this, the modern viewpoint is looking at ways in which to reduce this overall time and cost element. One strategy is to impart an approach of ‘accelerated development’ which, if done sensibly, can present an attractive and viable option. Quality focused planning, e.g. facilitated by quality by design, can also be used to potentially ‘shave off’ time to approval, whilst maintaining all important quality and regulatory maneuverability. Although faster development is attractive, regulatory aspects, particularly regulatory CMC also needs to keep up pace - which presents a number of difficult challenges. 

Pinch points:

• Sometimes it may become necessary to ‘challenge the norm’ and push back on certain regulations, within valid reason.

• FDA Breakthrough Therapy designation and EMA Priority Medicines (PRIME) designation provide an automatic ticket to enter the ‘fast lane’ - so welcome to the reality!

• Above all it is still important to have a well authored and ‘watertight’ regulatory dossier by which the competent authority will review the drug product in order to issue final marketing approval.

This session provides an overview of modern regulatory CMC strategies which may be selectively applied for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the overall time and cost. This ‘interactive’ session will focus on biopharmaceuticals, biologics, ATMPs, vaccines and biosimilars. Collective team discussions, whiteboard exemplification and workthroughs will be made on key topic points.

Topics to be Covered:

• Understanding of ‘the nature of the challenge’: from concept to authorization

• Modern mindsets: Technically driven approaches: ‘accelerated development’ pros and cons

• Be ready to ‘fast-track’- Breakthrough Therapy designation & Priority Medicines (PRIME); accelerated approval; ‘rolling’ submissions

• Exploration of the lifecycle of the investigational and final dossier:

• Breakdown of Timelines: Important Milestones

• High level dissection of CTD module 3: IND/IMPD – BLA/MAA - essential content and structuring

• The bridge between US and EU - important considerations

• Navigation of the essential guidelines and building blocks: biopharmaceuticals, biologics, ATMPs,vaccines, biosimilars; objective strategies of each

• Using Quality by Design to your best advantage

• Rest of World (RoW) CMC / regulatory considerations.

• Case Study of common issues: regulatory CMC

  • Richard Dennett, Ph.D. - Director, Voisin Consulting Life Sciences

9 am 5 pm (480 mins)

Advanced Control Strategies in Bioprocessing and Biomanufacturing: Disruptive Technologies and Emerging Platforms for Biologics Facilities of the Future

Advanced Control Strategies in Bioprocessing and Biomanufacturing: Disruptive Technologies and Emerging Platforms for Biologics Facilities of the Future

Process control and product quality control are two of the hallmarks of successful biomanufacturing.  However, the biologics manufacturing industry lags far behind other industries in terms of developing advanced process control systems that monitor and adjust processes and anticipate errors and anomalies in manufacturing as batches of product are produced. This symposium will discuss some of the state-of-the-art technologies emerging to help the biologics industry move towards improved product and process control and more modern manufacturing, as well as discuss the current gaps in technology that must be resolved in order to drive the biologics industry forward. Examples and applications of these concepts in current biomanufacturing facilities will also be presented.

9 am 5 pm (480 mins)

Cell-Based Immunotherapies – From Concept to Commercialization

Cell-Based Immunotherapies – From Concept to Commercialization

Cell-based immunotherapies have the potential to transform current medical practice and offer an opportunity to effectively manage what were once considered untreatable diseases. Despite a large increase in basic science activity in the cell therapy arena, alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity – with the number of cell based therapeutics in mainstream use remaining comparatively low. This course serves to incorporate key aspects of the commercialization process and examines how therapeutic candidates can be successfully translated from basic science into commercially viable products. The course will address fundamental translational barriers spanning the so-called "valley of death" and delineate sustainable and efficient mechanisms that can support the commercialization process. Topic coverage will include preclinical, clinical, manufacturing, intellectual property, regulation and market components.

  • David Brindley, MEng, DPhil, FRI, FRSA - Managing Partner, IP Asset Ventures

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

Comparability for Cell and Gene Therapy Products

Comparability for Cell and Gene Therapy Products

Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality and therefore safety and efficacy of the product; this requires data beyond meeting current specifications. With any biological product this is challenging, for cell, gene and tissue products that cannot be fully characterized the challenges are greater still. Concerns about comparability undertaken during development are common issues raised during review and often delay market approval or contribute to failure. This course explains what comparability is and how to develop a successful comparability protocol.

Workshop Learning Overview

• What is comparability?

• Why is meeting existing specifications not comparability?

• How do I apply the principles of comparability to highly variable products?

• Case studies: Common mistakes with comparability and their consequences.

• Interactive exercise: Spot the weaknesses and propose improvements to a worked comparability study

  • Speaker Christopher Bravery, Ph.D. - Director, Consulting, Advanced Biologicals Ltd., United Kingdom

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

Main agenda

Networking Refreshment Break

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

Continuous Processing Symposium

Cadence Acoustic Separator and Implementation Potential for Mammalian Harvest or Continuous Processing

  • Daniel LaCasse - Principal Scientist, BioTherapuetics R&D, Purification Process Development, Pfizer

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

Continuous Processing Symposium

Approaches to Improving Chromatographic Productivity: Scale Up Evaluation

  • Lindsay Arnold - Scientist, BioProcess Engineering, MedImmune

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

Continuous Processing Symposium

In-line Diafiltration (ILDF) – A Practical Solution for Continuous Buffer Exchange and Increased Plant Versatility

  • Briana Russo, MSc. - Process Development Engineer II, Pre-Clinical Manufacturing & Process Development, Regeneron Pharmaceuticals, Inc.

12:15 pm 1:30 pm (75 mins)

Main agenda

Lunch Break

1 pm 5:30 pm (270 mins)

Applying Innovative Chromatography Tools for Purification and Recovery of Biomolecules

Applying Innovative Chromatography Tools for Purification and Recovery of Biomolecules

Chairperson:

Dr. Carsten Voß, Application Specialist, Process Chromatography, Bio-Rad Laboratories

Join industry peers and thought leaders at this downstream purification workshop to learn and discuss approaches and new technologies to purify diverse biomolecules and to quantify impurities in downstream processes. The workshop will focus on strategies for virus and monoclonal antibody purification, viral clearance, and aggregate removal challenges. The interactions between the protein molecules and chromatography resins will be presented and how these properties can increase overall process efficiencies downstream. Working strategies for robust method development and optimization will be discussed in detail. The advantages of understanding these interactions and method optimization will be demonstrated by case study examples in industry, which include efficient capture of target protein from expression culture, the removal and quantification of process impurities, the separation of closely related species, such as product degradation fragments and high molecular weight aggregates. A networking reception will conclude this workshop to provide opportunities to engage with industry professionals and discuss your current separation challenges.

Key learnings:

• Understand the interactions between chromatography resins and biomolecules

• Listen and discuss new case studies in process development with focus on viral clearance, virus and mAb purification and aggregate removal

• Develop effective purification methods

• Discuss technologies that simplify quantification of host cell impurities in process development, quality control and biomanufacturing

• Collaborate with industry professionals and discuss current separation challenges


A main conference registration is not required to attend this workshop.  You may register only for this workshop here.  Limited seats available.

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

Continuous Processing Symposium

Chairman’s Remarks

  • Marc Bisschops, Ph.D. - Senior Principal Scientist, Continuous Processing, Pall Life Sciences

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

Continuous Processing Symposium

Continuous Diafiltration Using Countercurrent Staging

This work examines a novel approach for continuous diafiltration using Pall InLine Concentrators arranged in a countercurrent staged configuration. Experimental results obtained using a polyclonal immunoglobulin are in excellent agreement with model predictions, providing a framework for analyzing and optimizing the diafiltration performance. The countercurrent staged diafiltration not only provides for continuous buffer exchange, it also significantly reduces the number of pump passes while providing opportunities for reduced buffer requirements in final formulation.

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

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

Continuous Processing Symposium

Economic Evaluation of Continuous Downstream Bioprocessing

  • Mark Schofield, Ph.D. - Principal R&D Engineer, Pall Life Sciences

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

Main agenda

Networking Refreshment Break

3:15 pm 4 pm (45 mins)

Continuous Processing Symposium

Panel Discussion: Debottlenecking Batch Processes by Adopting Continuous

  • Where do you see the bottlenecks today in batch processing of mAbs and other recombinant proteins?
  • What does process intensification mean to you?
  • What do you feel will be the impact of integrated unit operations?
  • Where do you perceive the challenges will be after implementation of continuous processing?
  • Moderator Peter Levison, Ph.D. - Senior Marketing Director, Downstream Processing, Pall Life Sciences

4 pm 4:30 pm (30 mins)

Continuous Processing Symposium

Continuous BioManufacturing: Past, Present, and Future

  • Sadettin Ozturk, Ph.D. - SVP, Process and Analytical Development, MassBiologics

4:30 pm 5 pm (30 mins)

Continuous Processing Symposium

A Look at Reality: The Short-term Outlook for Continuous Manufacturing of Biologics

Continuous manufacturing of pharmaceutical-based products has become reality. Now the Industry’s next big question is what is the outlook for biologics? Are technology advances in manufacturing, automation, and testing occurring at a pace to allow for short-term implementation of this approach? And what does “continuous” actually mean when referring to biological products; have we reached this capability already by definition? This presentation will present current Industry information, challenges, and decision methodology around the capability to implement continuous manufacturing platforms.

  • Jeff Odum - Global Technology Partner, Strategic Manufacturing Concept Group, NNE

5 pm 5 pm (0 mins)

Main agenda

Close of Symposiums