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Key Sessions

Toni Hoover, Ph.D.

Harnessing Science, Technology and Innovation to Improve Global Health

Bill & Melinda Gates Foundation

Rick Berke

STAT Panel Discussion - President Clinton or President Trump: What Our Next President Will Mean for Biotech and Pharma

STAT (STATnews.com)

7:30 am 8 am (30 mins)

Main agenda

Single-use XCell™ ATF Systems for Continuous Processing: 100% Cell Retention, 8x Faster Set-up, No autoclave

Single-use XCell™ ATF Systems for Continuous Processing: 100% Cell Retention, 8x Faster Set-up, No autoclave Christine Gebski, Vice President, Product Management and Field Application, Repligen

Speaker: Christine Gebski, Vice President, Product Management and Field Application, Repligen


A light continental breakfast will be served during this workshop

12:35 pm 1:05 pm (30 mins)

Main agenda

cGMP Biologics Production Using Corynex ® : A Highly-Productive Gram-Positive Microbial Protein Secretion System

cGMP Biologics Production Using Corynex®: A Highly-Productive Gram-Positive Microbial Protein Secretion System

Yoshimi Kikuchi, Ph.D., Executive Professional and Group Manager, Recombinant Protein Research Group, Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., Japan

12:35 pm 1:05 pm (30 mins)

Main agenda

Advanced Materials for Single Use Systems

Advanced Materials for Single Use Systems

Jayanthi Grebin, Product Manager, Life Sciences, Entegris Inc

12:35 pm 1:05 pm (30 mins)

Main agenda

Fast Trak Your Molecule to Market: When, Why and How to Outsource Biomanufacturing

Speaker TBA

12:35 pm 1:05 pm (30 mins)

Main agenda

An Integrated BalanCD ® CHO Media Solution for Early Therapeutic Antibody Development, Scale-Up and Commercial Supply

An Integrated BalanCD® CHO Media Solution for Early Therapeutic  Antibody Development, Scale-Up and Commercial Supply

Jessie Ni, Ph.D, CSO, Irvine Scientific 

Yves Durocher, Ph.D, Research Office, National Research Council Canada

12:35 pm 1:05 pm (30 mins)

Main agenda

Reveal Information that Gives Insights – New Approaches to Sub-Visible Particle Characterization

Reveal Information that Gives Insights – New Approaches to Sub-Visible Particle Characterization

Dr. Josefina Nilsson, Head of EM services, Vironova AB

Dr. Gustaf Kyhlberg, Ph.D., Product Manager MiniTEM, Vironova AB

9:15 am 6 pm (525 mins)

Main agenda

BWB Exhibit Hall Open

Connect with 200+ exhibitors who represent global technology leaders and service providers working across:

1) Bioprocessing

2) Regenerative Medicine

3) Clinical Trials

4) Biorepositories

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

BWB Theater

Harnessing Science, Technology and Innovation to Improve Global Health

  • Speaker Toni Hoover, Ph.D. - Director, Strategy, Planning, and Management for Global Health, Bill & Melinda Gates Foundation

10:20 am 10:30 am (10 mins)

Main agenda

Cost Effective Risk Mitigation Upstream Using the Size exclusion-based Virosart® Media Filter

Bioreactor contamination incidents related to virus contamination of raw materials have raised concerns that require risk mitigation. Size exclusion-based filtration provides a robust strategy for protection of cell culture media and other additives. This presentation will discuss the characteristics of the new Virosart® Media Filter including virus retention performance and data demonstrating complete retention of leptospira and mycoplasma. Additionally, data from filterability and cell growth studies will be discussed. 

  • Birte Kleindienst - Junior Product Manager Virus Clearance , Sartorius Stedim Biotech GmbH

10:30 am 10:40 am (10 mins)

BWB Theater

Asahi Kasei Product Presentation

10:40 am 10:50 am (10 mins)

BWB Theater

How to Reduce Costs, Make Informed Decisions and Gain Insight for Innovation Through BioSolve

The company is the developer of BioSolve, the biopharmaceutical industry’s most powerful bioprocess & economic analysis software. The product range enables innovators to reduce manufacturing costs and make informed process decisions to improve profitability and ultimately patient access. In this presentation, we introduce how it can provide standardized and industry-wide information across organizations, helping rationalize and de-risk their business decision-making.

  • Yuki Abe - Senior Consultant Engineer , BioPharm Services Ltd.

10:50 am 11 am (10 mins)

BWB Theater

Increasing Protein Production with Novel Cell-Ess Supplement without Affecting Metabolic Profile

Enhancing protein production is a common bioproduction goal. A concentration of 1% Cell Ess supplement resulted in a 37% increase in productivity. As a feed, it resulted in a 25% increase in yield and extension of peak protein production. Our results suggest that an increase in protein production may not require a change in the metabolic state of the cells.

  • Adam Elhofy - Chief Science Officer , Essential Pharmaceuticals LLC

11:30 am 12:30 pm (60 mins)

BWB Theater

Oral Poster Presentations

Six of the most outstanding posters will be selected to deliver oral presentations on the BWB Theater.  Each presentation will be 10 minutes, with 6 total presenters.

12:30 pm 1 pm (30 mins)

Main agenda

Patient-Driven Tech: Co-creating New Models of Value

  • Dave Fuehrer - President & Co-Founder, SC Research Ventures, Inc.

1:10 pm 1:20 pm (10 mins)

BWB Theater

Lonza Presentation

Speaker and presentation title TBD

1:20 pm 1:35 pm (15 mins)

BWB Theater

The BIOne Benchtop Single-use Bioreactor System for Mammalian Cell Growth and Recombinant Protein Production Provides As a Robust Model for Bioprocess Development

Distek, Inc. has developed a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production. The pre-sterilized BIOne system is engineered with a disposable headplate welded to a triple-layered liner that can be easily inserted into a non-sterile bioreactor glass vessel, converting it to a sterile, disposable SUB within a matter of seconds.

  • Mark Arjona - Product Line Manager , Distek, Inc.

1:35 pm 1:45 pm (10 mins)

BWB Theater

Qualification of Single Use In-line Sensors in Continuous Bioprocessing

Requirements for batch versus continuous processing will be compared along the lines of the design attributes of single use sensors for pressure, temperature, conductivity, UV absorbance and flow.  The impact of  time and type of exposure of the sensor if the continuous process is more lengthy along with the susceptibility of the sensor to drift/change in calibration over time due to extended processing periods will be presented.  This includes theoretical information and data on the PendoTECH Single Use Sensors that are being used successfully in key applications including bioreactor pressure monitoring, depth filtration, crossflow/TFF, and chromatography for both development and GMP operations. They do not require calibration and come ready to use because in the manufacturing process each sensor undergoes several tests to ensure it is in calibration range and functioning properly. They are qualified for gamma irradiation to 50 KGys.  

  • Jim Furey - General Manager, PendoTECH

1:45 pm 1:55 pm (10 mins)

Main agenda

C1 Expression System – A Journey to Displace CHO Cells with Breakthrough Cell Expression

Dyadic’s C1 technology has the potential to change the way in which companies bring their biologic vaccines and drugs to market faster, in greater volumes and at lower cost, with newer beneficial properties that most importantly save lives.

  • Mark Emalfarb - Chief Executive Officer , Dyadic International, Inc.

1:55 pm 2:15 pm (20 mins)

Main agenda

How Development of New Generation Single-use Films Can Ensure Optimal Performance across the Full Bioprocess Unit Operation Workflow

The application of single-use systems for manufacturing biopharmaceuticals has become more widely adopted in recent years with single-use vessels now utilized in every process operation from upstream to down. At the heart of single-use systems is the plastic film from which they are made. The materials of construction must be consistent, biocompatible, chemically inert, and have a low level of extractables. Typically, multilayer films are required in order to meet the performance demands for use in bioprocess applications. This presentation focuses on the importance of resin selection and film architecture on achieving critical to quality attributes for the design of a bioprocess film.

  • Susan Burke - Material Science Leader , GE Healthcare

2:15 pm 3:45 pm (90 mins)

BWB Theater

Town Hall Forum: An Update on Single-Use Standardization and Alignment

Moderator: James Dean Vogel, Founder and Director, The BioProcess Insitute

  • Moderator James Dean Vogel - Founder and Director , The BioProcess Institute

4 pm 4:10 pm (10 mins)

BWB Theater

Parallel Automated Solutions for Efficient High-throughput Chromatography and Analysis

Chromatographic separation and analysis of macromolecules in bioprocessing workflows typically require parallel testing under multiple experimental conditions. Performing the processes under these conditions require automation, suitable matrix chemistry and an easy way to input experimental condition variables. In order to address this need TECAN has developed Bioprocessing workstations. The workstations include Automated TECAN EVO liquid handler, ATOLL Robocolumns (Repligen) and MSIA tip based column technologies (Thermo Fisher Scientific). The various features of the liquid handler coupled with software wizards offer robust solutions that have been adapted to a variety of laboratory workflows. The features of the Bioprocessing stations and their use in experimentation will be briefly discussed.

  • Tal Murthy - Senior Application Scientist , Tecan

4:10 pm 4:30 pm (20 mins)

BWB Theater

A New Fab-Fusion Protein Therapeutic: Design, Production & Purification

We describe the design, development and manufacture of a unique antibody-fusion protein consisting of a Fab-linked enzyme rather than the more typical Fc-linked fusion protein. VAL-1221, a preclinical product candidate for glycogen-storage diseases, contains a humanized anti-dsDNA Fab genetically linked to the acid alpha glucosidase enzyme (GAA). To substitute for the Fc-directed Protein-A capture step in most antibody and Fc-protein purifications, we compared alternative affinity supports focused on the Fab and selected a Protein L resin. Ion-exchange and hydrophobic-interaction chromatography polishing steps followed to remove host-cell proteins (HCP) and excess light chain. Purification challenges included the sensitivity of the GAA to pH below 3.5 and above 7.0, a tendency for HCP to track with the fusion protein on some steps, and high levels of free and dimeric light chain in the Protein L eluate. The final process overcame these challenges for production of clinical material at the 250L scale.

  • Michiel Ultee, Valerion Therapeutics
  • Emily Schirmer, Catalent Pharma Solutions
  • Dustin Armstrong, Valerion Therapeutics

4:30 pm 4:40 pm (10 mins)

BWB Theater

Designing Robust Virus Filtration Processes to Maximize Operational Flexibility while Achieving Small Virus Removal

Robust parvovirus clearance data for multiple protein products on Planova™ 20N and BioEX filters indicate broad operating spaces where robust parvovirus clearance can be consistently achieved without or with buffer flush. We also show the importance of designing viral clearance studies to have appropriate virus load in order to accurately evaluate the capability of the process

  • Alexander Schwartz - Senior Research Associate , Asahi Kasei Bioprocess America, Inc.

4:40 pm 4:50 pm (10 mins)

Main agenda

Next Generation Single-Use Systems Connectivity

While single-use systems have advanced in their application and usage over the past ten years, the manner in which fluid path/tubing assembly connections are made has not fundamentally changed.  BioLink™ modular overmolding is a new technology that evolves these connections by combining the best attributes of traditional overmolding with the speed and flexibility that established mechanical connections as an industry mainstay. Visit www.meissner.com for more information.  

  • Max Blomberg - Director of Operations , Meissner Filtration Products

5 pm 6 pm (60 mins)

BWB Theater

STAT Panel Discussion - President Clinton or President Trump: What Our Next President Will Mean for Biotech and Pharma

  • Moderator Rick Berke - Executive Editor, STAT (STATnews.com)
  • Panelist Mason Tenaglia - Vice President, IMS Institute for Healthcare Informatics, Payer & Managed Care Insights
  • Panelist Damian Garde - National Biotech Reporter , STAT (STATnews.com)
  • Panelist Dylan Scott - Washington Correspondent, STAT (STATnews.com)
  • Panelist David Meeker, M.D. - Executive Vice President, Head, Sanofi Genzyme
  • Panelist Kathleen Weldon Tregoning - Senior Vice President, Corporate Affairs , Biogen

6 pm 10 pm (240 mins)

Main agenda

Party in the Park Featuring Don Felder, Formerly of The Eagles

October 6 | 6pm-10pm | The Lawn on D

The conference may end on Friday, but not before a blow-out party featuring4-time Grammy Award Winner and Rock and Roll Hall of Famer Don Felder, formerlyof The Eagles headlining the all-new Party in the Park. Enjoy live performancesof The Eagles’ greatest hits including Hotel California, Life in the Fast Lane,Take It to the Limit, and more! Join your fellow peers and colleagues for afirst-of-its-kind outdoor interactive social event featuring live music, games,and Boston’s tastiest food trucks!

This is a complimentary event for all registered attendees.