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8:00am - 9:00am 60 mins
Main agenda
Coffee & Registration
9:00am - 5:00pm 480 mins
Two Day Training Course
Two Day Training Course: Introduction to Biopharmaceutical Manufacturing
  • Sheila Magil, Ph.D. - Senior Consultant, BioProcess Technology Consultants
  • Frank Riske, Ph.D. - Consultant, BioProcess Technology Consultants
more

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.

Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15

Tuesday September 26:

Refreshment Break: 9:45-10:10

Lunch: 12:25-1:40

Refreshment Break: 3:15-3:30

9:00am - 5:00pm 480 mins
Two Day Training Course
Two Day Training Course: CMC Analytical, Comparability and Stability Studies
  • Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
more

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.

Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15

Tuesday September 26:

Refreshment Break: 9:45-10:10

Lunch: 12:25-1:40

Refreshment Break: 3:15-3:30


9:00am - 5:00pm 480 mins
Cell-Based Immunotherapies – From Concept to Commercialization
Cell-Based Immunotherapies – From Concept to Commercialization
  • David Brindley, MEng, DPhil, FRI, FRSA - Managing Partner, IP Asset Ventures
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Course Outline:

•Introduction 

•Regenerative medicine product overview 

•Market Overview 

•Assessment of the Factors Affecting the Commercialization of Cellular Based Therapeutics 

•Biomanufacturing Processes: immunotherapy, CAR-T, exosome, gene vector 

•CAR-T: Product, Process and Patents 

•Clinical Trials and Regulation: How do they apply to Regen Med?

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.

Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15

9:00am - 5:00pm 480 mins
Comparability for Cell and Gene Therapy Products
Comparability for Cell and Gene Therapy Products
  • Speaker Christopher Bravery, Ph.D. - Director, Consulting, Advanced Biologicals Ltd., United Kingdom
more

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

Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15


9:00am - 5:00pm 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
  • Speaker Dan Kopac - Technology Expert PAT, Sartorius Stedim Biotech North America
  • Speaker Bill Whitford - Strategic Solutions Leader, BioProcess , GE Healthcare
  • Chairman & Speaker Robert Thomas, Ph.D. - Reader in Manufacturing for Cell Based Therapies; EPSRC Early Career Fellow, Centre for Biological Engineering (CBE), Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University
  • Speaker Jonathan Bones, Ph.D. - Principal Investigator, NIBRT Characterization and Comparability Laboratory, National Institute for Bioprocessing Research & Training (NIBRT)
  • Speaker Chris McCready - Lead Data Scientist, Sartorius Stedim Data Analytics AB
  • Speaker Viktor Konakovsky - Marie Curie Fellow, Fujifilm Diosynth Biotechnologies, UK
more

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.

Opening Remarks by our Chairman: 

Bill Whitford, Strategic Solutions Leader, Cell Culture, Bioprocess, GE Healthcare

9:05 

PAT Auto Feedback Control of CPP’s Using Modern In-SituAnalytics

Dan Kopec, Technology Expert PAT, Sartorius Stedim Biotech North America

Irrespective of the process, automation requires rapid measurement and high data density to achieve robust and effective auto feedback control loops.  Within this context, it is generally understood that sensors/ analyzers, need to be dedicated and directly integrated (in-situ or on-line) with the process vessel in test. By definition, automation requires that the human component is removed from the process  

Classic Batch/ Fed-Batch bioprocessing has historically relied on conservative, fixed feeding via indirect and/or gross manual control strategies. This approach severely limits one’s ability to improve the efficiencies and quality of the product.  It is clear, however, that there have been past technology limitations e.g. sensor robustness, and limited process adaptations,   specifically for in-situ monitoring of cell state, product, nutrient consumption and metabolite production.  New technologies for bioprocessing are emerging and proving to fulfill these basic automation requirements, and to meet the specific needs of bioprocessing; e.g. consistent sensors across multiples scales and multiple formats (Single-use and Multi-use).  The need for these technologies has also increased with the advent of continuous bioprocess, perfusion based processes, as well as autologous cell therapy cell expansion.

Finely controlled feedback or automation of high Impact critical process parameters such as viable cell volume and nutrients/ metabolites is now a reality.  This session/workshop will feature  a number of case studies with auto feedback control loops  based on in-situ advanced analytical technologies carried out at different bioreactor scales and formats,  with  seamless integration into the control system.

9:45 

Fermentation Data Integration, Analysis and Automationwith Antha

Markus Gershater, Chief Scientific Officer, Synthace

To address the complexities inherent in stirred tank bioprocesses, sophisticated approaches such as optimal experimental design (a.k.a. Active Learning) are highly beneficial. Many runs in stirred tanks are required for this approach, which have historically been exceptionally labour intensive to carry out. However, the development of automated, single use bioreactor arrays such as the Sartorius Ambr250 has been transformational in the number of fermentations that can be carried out in parallel. Dynamic sampling across multiple bioreactors can produce in excess of 800 samples, each of which have on-line and off-line data streams across 100s of time points. The task of handling all these samples and integrating the data from the multitude of on- and off-line analytics then becomes a major bottleneck. Here, we present how the Antha Operating System can be used to manag e sample streams and integrate analytics, automatically generating structured fermentation datasets for a range of sophisticated analyses. With the Antha Operating System, automated liquid handling protocols can easily and flexibly be put in place to aliquot bioprocess samples for off-line analytics. Antha records where every sample has come from and where it has been moved to such that every sample can be traced from its origin to the resulting analytic data set. This enables the auto generation of combined on-/off-line analytics plots. Beyond this, Antha can interface with a multitude of lab equipment for liquid handling and data analytics. The Antha OS is a cloud based laboratory workflow editor with an intuitive user interface for flexibly reprogramming automation platforms providing rapid high throughput experimentation, from setting up 100s of DNA construct assemblies through to running high dimensional design of experimentation optimisations, all with the power of rep roducibi lity and importantly traceability.

10:15 

Break

10:45 

Late Breaking Presentation

Jonathan Bones, National Institute for Bioprocessing

11:15 

Simplifying Dynamic Mechanistic Modelling for Optimisation of Cell Therapy Process Development and Manufacture

Robert J Thomas MPharm Ph.D., Reader in Manufacturing for Cell Based Therapies;EPSRC Early Career Fellow, Centre for Biological Engineering (CBE), Wolfson Schoolof Mechanical and Manufacturing Engineering, Loughborough University

Simplifying Dynamic Mechanistic Modelling for Optimisation of Cell Therapy Process Development and Manufacture

o Identification of the types of dynamic that make cell culture processes challenging to optimise and control

o Introduction of a workflow and toolset to support definition of culture dynamics and optimisation of cell culture operation

o Case studies of process improvement opportunities (in particular erythroid progenitors for red cell production and pluripotent derived megakaryocytes for platelet production)

11:45 

Application of model predictive control methods for forecasting and optimization of biological processes

Chris Mc Cready, Lead Scientist, Sartorius  Stedim Data Analytics AB

Use of multivariate modeling techniques is now a preferred common practice for monitoring of biological manufacturing processes.  Presently monitoring consists of tracking the process up to the current time or maturity.  This session presents a technique for predicting the future process trajectories to allow forecasting of future biological performance and prediction of final qualities for batch processes. Application of these imputation methods within an optimization framework is provided to demonstrate their use for process optimization or model predictive control (MPC). This is particularly useful in batch processes where traditional MPC technologies are not suitable. A case study is provided demonstrating the application of MPC within Umetrics’ SIMCA-online on a fed batch process to determine optimal feed and operating conditions to maximize specific growth rate and final titer. The session is concluded with remarks regarding rapid development of production-scale monitoring and control policies through the use of scale-up models on small scale development platforms such as Sartorius’ ambr system.

12:15

Lunch 

1:30

Advanced Control Strategies in Bioprocessing and Biomanufacturing

Bill Whitford, Strategic Solutions Leader, Cell Culture, Bioprocess, GE Healthcare

Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. Heightened computing power and connectivity, automation and robotics are enabling this revolution. New in-line (SU) probes and automated at-line (cell- and cell-free) sampling feeding such high-throughput analytics as NIR and SPR is producing a lake of data to be processed. But, it is the ultra-fast microprocessors, cheap and flexible data storage, as well as advanced interfacing, process analytics and control algorithms that determine a quantum leap in manufacturing capability. Adaptive fuzzy expert systems now employ artificial intelligence and cloud hosting to provide a continuous optimization of process performance using previously developed metabolic models and data from the current process a s well a s from previous runs.

2:45

Break

3:15

Monitoring, Modeling and Control (M3C) for Robust Mammalian Cell Culture Bioprocesses

Viktor Konakovsky, Fujifilm Diosynth Biotechnologies

Within this body of work we implemented online process monitoring and control in our labs using PAT (Process Analytical Technology) tools and scale-free control variables in mammalian CHO (Chinese Hamster Ovary) cell culture processes to improve productivity, robustness and predictability at different scales. Predictive models for cell physiology and sensor signals were established based on historical data analysis of industrial process development data at lab (2L) and pilot plant scale (80L). The developed models proved to be scale-independent and transferable to other CHO clones, which allowed their application on different processes with limited prior information. Optimization of feeding in fed-batch mode was achieved by controlling the specific glucose consumption rate within a narrow range in real time using PAT tools, such as an online metabolic analyser and a capacitance probe for monitoring and control purposes. This led to very stable glucose, lactic acid and pH profiles, improving productivity and robustness of the platform process with scale-free parameters.

Mechanistic, statistical and in-silico models under dynamic fed-batch conditions were used to gain novel insights into cell metabolism, and allowed a predictive run forecast at 2L and 12000L scale. The established methodologies facilitate and improve process transfer and scale-up of industrial mAb (monoclonal Antibody) platform processes through advanced process monitoring and control. This is in line with recommendations from the FDA (Food and Drugs Administration) and EMA (European Medicines Agency) to implement PAT & QbD (Quality by Design) approaches in the biopharmaceutical industry to ensure consistent quality of medicines for the safety of patients.

Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15

9:00am - 5:00pm 480 mins
Biosimilar Development and Production
Biosimilar Development and Production
  • Sadettin Ozturk, Ph.D. - SVP, Process and Analytical Development, MassBiologics
  • Tudor Arvinte, Ph.D. - Professor / CEO, University of Geneva Switzerland / Therapeomic Inc.
  • Joanna Brougher Esq., MPH - Owner and Principal, BioPharma Law Group, PLLC
  • David Wylie, Ph.D. - Principal Scientist, Biologics Analytical Sciences, Merck and Co.
  • Gay Gauvin - Global Operations Director, Biosimilars, Amgen
more

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.

Chairperson and Introduction:

David Wylie, Ph.D., Principal Scientist, Biologics Analytical Sciences, Merck and Co.

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.

Analytical and Formulation Methods for Biosimilar and Interchangeable Development

Tudor Arvinte, Ph.D., Professor, University of Geneva, Switzerland & CEO of Therapeomic Inc.

The importance of orthogonal analytical methods in the characterization and formulation development development of biosimilar products will be documented by case studies. Examples will be presented of analytical approaches for the comparison of biosimilar and originator products regarding: i) the chemical and physical properties of the molecule and of the formulation ingredients; ii) batch-to-batch variation; and iii) potential aggregation of drug products after mixing with human plasma.

Biosimilars: the current state of the Biologics Price Competition and Innovation Act (BPCIA) and overview of the anti-patent climate

Joanna Brougher Esq., MPH, Owner & Principal at BioPharma Law Group PLLC

One June 12, 2017, the United States Supreme Court, in a unanimous opinion, reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting two “patent dance” provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). This decision permits manufacturers of biosimilars to begin marketing their biosimilar product prior to FDA approval and deprives the owner of the reference product of a means to force disclosure of the method used to manufacture the biosimilar. While the Supreme Court’s decision is largely seen as a victory for manufacturers of biosimilars who now have fewer obstacles to overcome in reaching the market, there are still many unanswered questions remaining following the decision. Some of the major topics that will be covered in this workshop are: an overview of the BPCIA, recent court decisions, who will “dance” now?, potential litigation strategies, and unanswered questions.

Group Discussion: Best Practices and Lessons Learned for Developing Biosimilars

Moderator: David Wylie, Ph.D., Principal Scientist, Biologics Analytical Sciences, Merck and Co.

Co-Moderator: Gay Gauvin, Global Operations Director, Biosimilars, Amgen

Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15

9:00am - 5:00pm 480 mins
Modern CMC Regulatory Strategies and Insights
Modern CMC Regulatory Strategies and Insights – from Concept to Approval
  • Richard Dennett, Ph.D. - Director, Voisin Consulting Life Sciences
more

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


Break Schedule:

Monday, September 25:

Refreshment Break: 10:15-10:45

Lunch: 12:15-1:30

Refreshment Break: 2:45-3:15

9:00am - 9:15am 15 mins
Vaccine Development and Production: Novel Technologies and Strategies
Symposium Moderator Welcome and Introduction
  • Joshua Speidel, Ph.D. - Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMP
more
9:15am - 9:45am 30 mins
Vaccine Development and Production: Novel Technologies and Strategies
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., PMP
more
9:45am - 10:30am 45 mins
Vaccine Development and Production: Novel Technologies and Strategies
Delivering Next Generation Vaccine Processes through Technology and Teamwork
  • Tiffany Rau, Ph.D. - Senior Consultant, BioProcess Technology Consultants, Inc.
more

The world and science is moving at a rapid pace and every day we read of a new discovery or technology that is going to revolutionize the industry. The vaccine industry as well as pharma and biotech have a passion to deliver lifesaving and improving products to the market but elimination of risk is a key consideration. New technologies have a greater risk just because they are different and teams and regulatory organization have less experience with them. Vaccines are also complex and many of the products and the processes have been in manufacturing for many years and they “work” so why change or develop differently? Today, the industry is under increased pressure for not only new vaccines but also ones that can be manufactured anywhere in the world, be delivered “easily” to remote locations, and, of course, they need to be economical. Different technologies will be discussed as well as implementation strategies to increase the likelihood of success from R and D to manufacturing. Let us revolutionize the industry TOGETHER!


10:30am - 11:00am 30 mins
Vaccine Development and Production: Novel Technologies and Strategies
Networking Refreshment Break
11:00am - 11:45am 45 mins
Vaccine Development and Production: Novel Technologies and Strategies
Bio-Analytical Comparability: Strategy for Implementing Process Changes, and Approval of New Manufacturing Facility
  • Indresh Srivastava, Ph.D. - Vice President, Process & Analytical Development, Senior Program Manager - Influenza, Protein Sciences Corporation
more

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.


11:45am - 12:45pm 60 mins
Vaccine Development and Production: Novel Technologies and Strategies
Panel Discussion: The Future of Vaccine Antigen Manufacturing
  • Moderator Joshua Speidel, Ph.D. - Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMP
  • Panelist Mario Barro, Ph.D. - Senior Director Innovation and External Networks, Head of Technologies FluNXT, Sanofi Pasteur
  • Panelist Indresh Srivastava, Ph.D. - Vice President, Process & Analytical Development, Senior Program Manager - Influenza, Protein Sciences Corporation
  • Panelist Tiffany Rau, Ph.D. - Senior Consultant, BioProcess Technology Consultants, Inc.
more
12:45pm - 2:15pm 90 mins
Vaccine Development and Production: Novel Technologies and Strategies
Networking Luncheon
2:15pm - 3:00pm 45 mins
Vaccine Development and Production: Novel Technologies and Strategies
Vaccine and Essential Medicine Delivery and Packaging Technologies for Use in Low-Resource Settings
  • Courtney Jarrahian - Technical Officer, Vaccine and Pharmaceutical Delivery Technologies, PATH
more

Emerging packaging and delivery technologies could improve safety, efficacy, and access to pharmaceuticals and vaccines for low-resource settings, including transdermal microarray (microneedle) patches, intradermal delivery devices, polymer containers, and compact prefilled autodisable delivery devices. PATH, an international global health organization, uses a comprehensive approach to assess, prioritize, and advance new technologies to meet critical health needs in partnership with industry and global stakeholders.

3:00pm - 3:45pm 45 mins
Vaccine Development and Production: Novel Technologies and Strategies
Challenges of Scaling Up Manufacture of a Frozen Ebola Vaccine
  • Lynne Isopi - Principal Scientist, Vaccine Drug Product Development, Merck
more
3:45pm - 4:15pm 30 mins
Vaccine Development and Production: Novel Technologies and Strategies
Networking Refreshment Break
4:15pm - 5:00pm 45 mins
Vaccine Development and Production: Novel Technologies and Strategies
Panel Discussion: Global Health Vaccine Manufacturing Challenges: Innovation to Support Reduced Cost of Goods
  • Moderator Joshua Speidel, Ph.D. - Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMP
  • Panelist Subhash Kapre, Ph.D. - CEO, Inventprise LLC
  • Panelist Peter Latham - President and Managing Partner, Latham BioPharm Group, Inc., PgMP
  • Panelist Lynne Isopi - Principal Scientist, Vaccine Drug Product Development, Merck
more
9:00am - 9:15am 15 mins
Continuous Processing Symposium
Chairman’s Opening Remarks
  • Peter Levison, Ph.D. - Senior Marketing Director, Downstream Processing, Pall Life Sciences
more
9:15am - 9:45am 30 mins
Continuous Processing Symposium
Perspectives on Continuous Processing
  • Howard Levine, Ph.D. - Founder, President and Principal Consultant, BioProcess Technology Consultants
more
9:45am - 10:15am 30 mins
Continuous Processing Symposium
Pilot-Scale Perfusion and Clarification Using Multidimensional Acoustic Wave Perfusion Device
  • William Napoli - Scientist, Bioprocess Technology and Expression, BioProcess Development, Merck & Co., Inc.
more

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.

10:15am - 10:45am 30 mins
Main agenda
Networking Refreshment Break
10:45am - 11:15am 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
more
11:15am - 11:45am 30 mins
Continuous Processing Symposium
Approaches to Improving Chromatographic Productivity: Scale Up Evaluation
  • Lindsay Arnold - Scientist, BioProcess Engineering, MedImmune
more
11:45am - 12:15pm 30 mins
Continuous Processing Symposium
In-line Diafiltration (ILDF) for Continuous Buffer Exchange and Increased Plant Versatility
  • Briana Russo, MSc. - Process Development Engineer II, Pre-Clinical Manufacturing & Process Development, Regeneron Pharmaceuticals, Inc.
more


In-Line Diafiltration (ILDF), using a staged, direct channel buffer injection, provides the first opportunity the biopharmaceutical industry has had to implement continuous buffer exchange.  This study characterizes the performance of the ILDF prototype and presents a case study of a potential process implementation that could eliminate tank constraints during commercial antibody production.

12:15pm - 1:30pm 75 mins
Main agenda
Lunch Break
1:00pm - 5:30pm 270 mins
Applying Innovative Chromatography Tools for Purification and Recovery of Biomolecules
Applying Innovative Chromatography Tools for Purification and Recovery of Biomolecules
  • Chairperson Carsten Voss, Ph.D. - Application Specialist, Process Chromatography, Bio-Rad Laboratories
  • Speaker Musaddeq Hussain, Ph.D. - Principal Scientist, Merck Research Laboratories
  • Speaker Tareq Jaber, Ph.D. - Senior Supervisor, Process Evaluation, Biologics Testing Solutions, Charles River Laboratories
  • Speaker William Rushton, M.S. - Process Chromatography Support Scientist, Process Chromatography, Bio-Rad Laboratories
  • Speaker Xuemei He, Ph.D. - R&D Manager, Process Chromatography, Bio-Rad Laboratories
  • Speaker Giorgio Carta, Ph.D. - Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia
more

Overview: Join industry peers and thought leaders and discover novel approaches to purify biomolecules and quantify impurities in downstream processes. This workshop will focus on strategies for virus and monoclonal antibody purification, viral clearance, and aggregate removal challenges. A panel discussion on downstream processing considerations and requirements will conclude the workshop followed by a networking reception to collaborate with industry professionals.


1:00 Chairman's Opening Remarks:

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


1:15 Challenges and Opportunities for Improved Resins for the Chromatographic Processing of Biopharmaceuticals

We provide an overview of recent advances in the development of resins for protein purification and in understanding protein-surface interactions that are responsible for separation. Specific applications considered are the separation of antibody aggregates and, in particular, soluble dimers, from monomers by cation exchange chromatography and the capture and purification of large proteins by anion exchange chromatography within polymer-grafted resins. A particular concern is the potential for protein unfolding on the chromatographic surface that can result in the undesirable formation of unfolded intermediates and aggregates during separation. We show that new large-pore resins with small particle size based on a hydrophilic backbone can prevent these phenomena resulting in moreeffective separation. Because of their efficient mass transfer characteristics and the reversibility of protein-surface interactions, these resins can be used for the frontal analysis separation of monomer-dimer mixtures resulting in high productivity. We also discuss the interaction of large proteins with hydrodynamic radius greater than 8 nm with resins containing polymeric surface extenders. By optimizing the porosity of the support matrix, the grafted polymers, and the mobile phase composition, high dynamic binding capacities can be attained resulting in effective capture of large biomacromolecules.

Giorgio Carta, Ph.D., Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia


1:45 Effective Processes for Virus Purification 

Xuemei He, PhD, R&D Manager, Process Chromatography, Bio-Rad Laboratories


2:15 Virus Clearance by Chromatography

Chromatography is the main purification process in monoclonal antibodies (MAB) and recombinant protein (rProtein) products. Multiple chromatography steps also can be used to remove impurities including viruses. We analyzed the overall performance of different chromatography types based on our internal database looking specifically for the log reduction factors for the most testable viruses; MuLV, MVM, PRV, and Reo-3. The following criteria were considered for building our database: a. MAB and rProtein studies. b. IND/BLA/feasibility studies and c. different vendors resins/membrane with various specifications. 

Tareq Jaber,  PhD, Senior Supervisor, Process Evaluation , Biologics Testing Solutions,  Charles River Laboratories


2:45 Break


3:00 Droplet Digital PCR for Host Residual DNA Quantification

The biologics manufacturer needs to demonstrate a safe level of host–residual DNA (hrDNA) in the purified drug.  Current testing model is: extract total DNA from the test sample and then quantitate by qPCR.  We have developed extraction-free methods where samples are (i) directly added to PCR reaction or (ii) protease-digested and then subjected to PCR.  We have developed direct droplet digital PCR methods for CHO, Pichia and E. coli hrDNA.  We show that in some ways droplet digital PCR works better than qPCR.

Musaddeq Hussain, PhD, Principal Scientist, Merck Research Laboratories


3:30 Non-Affinity Based Purification Platform for IgM

The biological properties of IgM antibodies make them very effective vehicles for in vitro diagnostics and therapeutics. However, purification of IgM antibodies is far more complex than that for IgG antibodies. Affinity chromatography is not ideal for purifying IgMs due to the required elution conditions. New data will be presented for a non-affinity based platform for IgM purification.

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


4:00 Panel Discussion with Workshop Speakers

Downstream Processing- Considerations and Requirements

Giorgio Carta, University of Virginia

Musaddeq Hussain, Merck Research Laboratories

Tareq Jaber, Charles River Laboratories

Xuemei He, Bio-Rad Laboratories

William Rushton, M.S, Process Chromatography Support Scientist, Bio-Rad Laboratories

Min Zhu, Ph.D., Director, Protein Science in Process Science, Boehringer Ingeilheim


4:40 Networking Reception


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

1:30pm - 1:45pm 15 mins
Continuous Processing Symposium
Chairman’s Remarks
  • Marc Bisschops, Ph.D. - Senior Principal Scientist, Continuous Processing, Pall Life Sciences
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1:45pm - 2:15pm 30 mins
Continuous Processing Symposium
Continuous Diafiltration Using Countercurrent Staging
  • Andrew Zydney, Ph.D. - Distinguished Professor and Department Head, Chemical Engineering, The Pennsylvania State University
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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.

2:15pm - 2:45pm 30 mins
Continuous Processing Symposium
Economic Evaluation of Continuous Downstream Bioprocessing
  • Mark Schofield, Ph.D. - Principal R&D Engineer, Pall Life Sciences
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1:30pm - 5:00pm 210 mins
Main agenda
Sartorius Site Tour to their Cambridge, MA facility
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Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry is delighted to share its bioanalytical testing laboratory in Cambridge, MA through a facility tour at BPI.  This is an extension of their contract testing capabilities currently on offer in Scotland. The custom built, state-of-the-art laboratories were opened in November 2016 and offers contract testing services to biopharmaceutical companies. The bioanalytical assay portfolio predominantly focused on mAbs includes target binding by SPR and ELISA, potency assays (development, qualification & validation for Lot Release & Stability), ADCC, CDC and full service SPR. The experienced team of scientists also support GMP biosafety testing on a range of products including Gene Therapies. Please join us for an afternoon of refreshments along with a facility overview and tour. To find out more about our contract testing services, visit www.biooutsource.com.

2:45pm - 3:15pm 30 mins
Main agenda
Networking Refreshment Break
3:15pm - 4:00pm 45 mins
Continuous Processing Symposium
Panel Discussion: Debottlenecking Batch Processes by Adopting Continuous
  • Moderator Peter Levison, Ph.D. - Senior Marketing Director, Downstream Processing, Pall Life Sciences
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  • 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?
4:00pm - 4:30pm 30 mins
Continuous Processing Symposium
Continuous BioManufacturing: Past, Present, and Future
  • Sadettin Ozturk, Ph.D. - SVP, Process and Analytical Development, MassBiologics
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4:30pm - 5:00pm 30 mins
Continuous Processing Symposium
A Look at Reality: The Short-term Outlook for Continuous Manufacturing of Biologics
  • Jeff Odum - Global Technology Partner, Strategic Manufacturing Concept Group, NNE
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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.

5:00pm - 5:00pm 0 mins
Main agenda
Close of Symposia