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Key Sessions

Ed Boyden, Ph.D.

Tools for Mapping and Repairing Disease States: Can We Make Therapeutic Invention Into a Mature Design Science?

Massachusetts Institute of Technology

J. Craig Venter, Ph.D.

Presentation Title TBA

Human Longevity, Inc.

Tyler Jacks, Ph.D.

The Convergence Model of Cancer Research: Solving the Problems of Cancer through Interdisciplinary Approaches

Massachusetts Institute of Technology

7:30am 8:00am (30 mins)

Main agenda

Breakfast & Technology Workshop: The Impact of Emerging Upstream and Downstream Technologies on Process Productivity and Economics

With an innovative side port that allows for simple resin unpacking, OPUS® 45R and OPUS® 60R columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or column cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in cGMP settings, and allows for re-use of the unpacked resin for other purposes. Test results on chromatographic performance, bioburden testing, shipping tests and simple unpacking procedure will be presented.

Please note: The exhibit hall is not open following this talk. The exhibit hall opens today at 9:45am


  • Christine Gebski - Vice President, Product Management and Field Application, Repligen

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

Main agenda

Refreshment Break in the BWB Poster & Exhibit Hall

9:50am 10:00am (10 mins)

Main agenda

The Journey of More Productive Cell Expression


The C1 platform technology is a hyper-productive fungal expression system which has been used to produce enzymes and proteins at yields up to 100 g/l, with 80% purity (~ 80 g/l of the target protein).  C1 is a leap in technology that has the potential to change the way in which both animal health and human biotech and pharmaceutical companies bring their biologic vaccines and drugs to market faster, in greater volumes, at lower cost, and with newer beneficial properties.

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

10:00am 10:10am (10 mins)

Main agenda

FlexAct® BT (Bag Tester): Point-of-use Leak Test of Flexboy® 2D Bags

FlexAct® BT is a Bag Tester solution for end users to control the absence of leaks that could occur during transportation and handling of 2D bags at the point of use. FlexAct® BT features the Sartocheck® 4 plus Bag tester and a set of two holders to perform pressure decay testing in a safe, fast, easy and reliable way. FlexAct® BT is supplied with a complete validation package and on-site service to achieve an easy validation.


  • Speaker Carole Langlois - Senior Product Manager, Fluid Management Technology, Sartorius Stedim Biotech FMT SAS

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

Main agenda

Implementation of High Throughput Analytics to Improve Process Efficiency and Economics


Increasing Phase I/II development productivity to reach the clinic faster is driving the adoption of high throughput analytical tools to reduce the turnaround time for results, increase sample capacity, and provide richer insight into quality.  The Octet HTX system, used to assess product titer and detect CHO-HCP and Residual Protein A impurities, is an example HT analytics transforming the development workflow.

  • Craig Tin - Director, Regional Marketing, Pall ForteBio LLC

10:20am 12:00pm (100 mins)

Main agenda

BioProcess International’s State of the Industry Report: 15 Years of Advancement

In June 2017, BioProcess International published The State of the Industry, a special report and ebook series designed to provide the biopharmaceutical industry with a unique perspective into the business decisions, technological advancements, and scientific breakthroughs over the last 15-years that define who we are as an industry today. This special series examines the successes, failures, and trends that have delivered the industry to this particular point in time. Reflecting the eleven core job functions and demographics that represent BioProcess International’s readership, the State of the Industry provides expert insight into the factors and decisions that impacted each step of the bioprocess. As part of the BWB festival, BioProcess International presents trends in four of the eleven core bioprocess stages: Research & Development; Lab Management; Process Development; Production/Manufacturing

Presenters:

The R&D Perspective: Mapping New Pathways from Discovery to Development

Cheryl Scott, Senior Technical Editor, BioProcess International

The Lab Manager’s Perspective: Ensuring Efficiency, Data Integrity, and Compliance

Maribel Rios, Managing Editor, BioProcess International

The Process Development Perspective: Implementing Tools for Optimization

Maribel Rios, Managing Editor, BioProcess International

The Manufacturing Perspective: Current Approaches to Bioprocess Intensification

Anne Montgomery, Editor in Chief, BioProcess International

  • Speaker Anne Montgomery - Editor in Chief, BioProcess International Magazine
  • Speaker Maribel Rios - Managing Editor, BioProcess International
  • Speaker Cheryl Scott - Senior Technical Editor, BioProcess International

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

Technology Workshop

Control Glycosylation and its Functional Impact on Therapeutic Antibody

Brought to you by BPI Sponsor: Irvine Scientific

Proper therapeutic antibody glycosylation is critical for its function and can be significantly influenced by it production process parameters, including culture media.  Results from two case studies demonstrate the exact nature of glycosylation-function relationship may be antibody-dependent and the potential necessity of antibody-specific approach in controlling glycosylation during its bio-production.

  • Jessie Ni, Ph.D. - Chief Scientific Officer, Irvine Scientific

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

Technology Workshop

Achieving Quality at Speed: Technological Advancements for High Throughput Process Development and Their Implications on Data Quality

Brought to you by BPI Sponsor: IDBS

Technological advancements for high throughput process development are allowing scientists to accelerate the time from discovery to manufacturing. In this session we will discuss the importance of using technology to optimize your data management processes to achieve quality at speed throughout the development life cycle.

  • Jarrod Medeiros - Product Manager, IDBS, Inc

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

Technology Workshop

Outsourcing Process Development in the Bid to Bring Rare Therapies to Clinic Faster

Brought to you by BPI Sponsor: GE Healthcare

  • Alex Tracy, Ph.D. - Vice President, Pharmaceutical Development, Roivant Sciences

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

Technology Workshop

Yes, You Can Run >300 Glycan Samples Yourself Per Day

Brought to you by BPI Sponsor: Sciex

Generate actionable glycan data from >300 samples per day in your own lab. Introducing a new SCIEX technology. One-hour sample prep of a 96-well plate, compatible with automation. Simply put the plate and the cartridge in the instrument; no other reagents to add. Obtain high resolution actionable data using the reliable chemistry from the makers of the PA 800 Plus.

  • Mark Lies, Ph.D. - Senior Product Manager, SCIEX

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

Technology Workshop

Beckman Coulter Workshop

12:35pm 1:55pm (80 mins)

Main agenda

Networking Luncheon in the BWB Poster & Exhibit Hall

12:35pm 1:55pm (80 mins)

Main agenda

3M Women in BioProcess Roundtable Forum and Lunch

Attendees will:

• Network with pioneers in the bioprocess field

• Learn from women leaders across a cross-section of companies

• Create personal connections with other women scientists

• Be considered for participation in an ongoing women in bioprocess mentorship program 

3M is offering this opportunity to current and future women leaders in science

Moderator:

Sanchayita Ghose, Ph.D., Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb

Panelists:

  • Wei Moline, VP and GM of 3M SPSD, Industrial Business Group, 3M
  • Hanne Bak, Ph.D., VP, Pre-clinical Manufacturing & Process Development, Regeneron Pharmaceutical, Inc.
  • Sangeetha Sagar, Ph.D., Head of Innovation Technology, Sanofi Pasteur
  • Adele Gulfo, EVP & Chief Strategy Officer, Mylan
  • Birgit Schoeberl, Ph.D., Consultant, Independent Consultants
  • Lynne Krummen, Ph.D., Vice President, Global Head Regulatory CMC, Genentech
  • Moderator Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
  • Panelist Wei Moline - Vice President and General Manager, 3M Separation and Purification Sciences
  • Panelist Hanne Bak, Ph.D. - Vice President, Pre-clinical Manufacturing & Process Development, Regeneron Pharmaceutical, Inc.
  • Panelist Sangeetha Sagar, Ph.D. - Head of Innovation Technology, Sanofi Pasteur
  • Panelist Adele Gulfo - Executive Vice President & Chief Strategy Officer, Mylan
  • Panelist Birgit Schoeberl, Ph.D. - Consultant, Independent Consultants
  • Panelist Lynne Krummen, Ph.D. - Vice President, Global Head Regulatory CMC, Roche/Genentech

12:35pm 2:05pm (90 mins)

Main agenda

3M Women in BioProcess Roundtable Forum and Lunch

Attendees will:

  • Network with pioneers in the bioprocess field
  • Learn from women leaders across a cross-section of companies
  • Create personal connections with other women scientists
  • Be considered for participation in an ongoing women in bioprocess mentorship program

Moderator:

  • Sanchayita Ghose, Director, Downstream, Biologics Process Development, Bristol Myers Squibb

Panelists:

  • Wei Moline, Vice President & General Manager, SPSD, 3M
  • Hanne Bak, Vice President, Process Development & Preclinical Manufacturing, Regeneron
  • Sangeetha Sagar, Head of Innovation Technology, Sanofi Pasteur
  • Adele Gulfo, EVP & chief Strategy officer, Mylan
  • Birgit Schoeberl, Transitioning in a new role
  • Lynne Krummen, VP of Technical Development of Biologics

3M is offering this opportunity to current and future women leaders in science.

*Limited Availability. All registrations are subject to 3M approval.

  • Panelist Wei Moline - Vice President and General Manager, 3M Separation and Purification Sciences
  • Panelist Cissy Young, Ph.D. - Executive Director, Russell Reynolds Associates

12:40pm 12:50pm (10 mins)

Main agenda

Sorting Workflow Using Sony FX500- Case Study of Sorting Memory and Naive T cells in a GMP Facility

The Sony FX500 cell sorter features single use fluidics that can be exchanged between samples to streamline operation and control sample carryover. Here we highlight a case study of sorting memory and naïve T cells in a GMP facility using FX500. System setup, performance and application data supporting this approach will be presented.

  • Speaker Deena Soni, Ph.D - Global Marketing Manager, Cell Sorters, Sony Biotechnology

1:30pm 1:40pm (10 mins)

Main agenda

10 Minute Presentation Fujilfilm

1:55pm 2:10pm (15 mins)

Main agenda

Supplier Change Notifications - Gaining Value through External Collaborations for Supplier Change Notifications


This topic will present the outcome of the joint discussions between BPOG (BioPhorum Operations Group) and BPSA (BioProcess Systems Alliance) for a period of 18 months between 20 drug manufacturers and 12 suppliers regarding the management of supplier change notifications.  The team’s journey, from initial scoping and objective setting to the creation of tools and supporting documentation will be presented. The benefits of the team’s change notification structure will be highlighted as a means of encouraging industry adoption of this practice and standardization of the handling of supplier changes.


  • Speaker Jeff Carter, Ph.D. - Strategic Projects Leader, Life Sciences, GE Healthcare

2:10pm 2:25pm (15 mins)

Main agenda

Single Use User Requirements - The Journey Towards User Requirements Standardization for Single-use Systems


This topic will present the ongoing activities of the joint initiative between BPOG (BioPhorum Operations Group) and BPSA (BioProcess Systems Alliance) regarding Single Use User Requirements.  Currently, 14 drug manufacturers and 16 suppliers are collectively working on this collaboration.  The team’s journey, from initial scoping and objective setting to delivering the roadmap and overcoming cross industry challenges will be presented. The benefits of the team’s work will be discussed as a means of encouraging industry adoption of this practice which should encourage swifter deployment of single-use technology due to the implementation of an industry wide standard set of expectations. This will help to mitigate concerns and risks as new biopharmaceutical products are brought to market.


  • Speaker Jeff Carter, Ph.D. - Strategic Projects Leader, Life Sciences, GE Healthcare

2:25pm 2:40pm (15 mins)

Main agenda

Mold Control - Mold Control and Detection In Biological Drug Substance Manufacturing Facilities: An Industry Perspective


The biopharmaceutical industry produces non-sterile and/or low-bioburden intermediates and bulk biologics (i.e. Drug Substances) using bioburden controlled processes in accordance to Q7A and Annex 2. In many cases, single mold isolation events have received a high level of scrutiny; the goal of this paper is to challenge this paradigm and provide the rationale for an enhanced control approach that focuses on trending of mold species as microbial indicators rather than on single isolation events. Molds, can also be part (in much lower numbers) of the normal microbial population of a biologics manufacturing facility and, therefore, mold isolation is not an unexpected event in non-aseptic processing environments. This presentation provides recommendations from a biopharmaceutical industry perspective on mold monitoring in biologics drug substance facilities and processes.  Additionally, recommendations on subjects commonly encountered in the establishment of a monitoring program, such as mold trending, responding to mold isolation events and best practices on mold prevention, are included. These recommendations assist biologic manufacturers in refining their current mold control strategy, as well as developing control strategies for new processes, facilities and products.  Establishing appropriate mold control programs is a key element of overall microbial control plans in biologics manufacturing facilities.


  • Randall Thompson - Principal Scientist, Quality Control, Global Microbiology, Shire

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

Main agenda

Tools for Mapping and Repairing Disease States: Can We Make Therapeutic Invention Into a Mature Design Science?

  • Ed Boyden, Ph.D. - Associate Professor, Media Lab and McGovern Institute Departments of Biological Engineering and Brain and Cognitive Sciences, Massachusetts Institute of Technology

3:30pm 4:00pm (30 mins)

Main agenda

Refreshment Break in the BWB Poster & Exhibit Hall

3:35pm 3:45pm (10 mins)

Main agenda

Automation Friendly Assay Design

Adaptation of potency assays to robotic systems has been a significant challenge for cell-based bioassays. We have experience automating quantitative and potency assays on Hamilton robotic systems, including assays based on proteins, nucleic acids, and cells. We will present the challenges and successes of adapting assays to automation, and share some of the lessons we’ve learned along the way.

  • Christopher Hepler - Group Leader, Cellular and Molecular Technologies, Catalent Pharma Solutions

3:45pm 3:55pm (10 mins)

Main agenda

Aseptic Filling via Single-Use Systems

Single-use systems which can function as closed systems facilitate streamlined aseptic filling operations.  These include isolator based filling systems for final container closure of drug product, but also RABs based filling of upstream process fluids and many operations in between.  Best practices associated with designing single-use systems for use in these critical applications will be covered. 

  • Speaker Max Blomberg - Director of Operations, Meissner Filtration Products

4:00pm 4:45pm (45 mins)

Main agenda

Presentation Title TBA

  • J. Craig Venter, Ph.D. - Co-Founder, Executive Chairman, Head of Scientific Strategy, Human Longevity, Inc.

4:45pm 5:15pm (30 mins)

Main agenda

The Convergence Model of Cancer Research: Solving the Problems of Cancer through Interdisciplinary Approaches

MIT’s Koch Institute for Integrative Cancer Research was created to take advantage of the strengths at MIT in cancer science and cancer-oriented engineering. The Institute fosters interdisciplinary thinking and collaboration to tackle the most challenging problems in cancer biology, diagnosis, early detection, and treatment. Tyler Jacks serves as the Director of the Koch Institute and also runs a cancer genetics and cancer immunology laboratory there. He will illustrate examples of progress against cancer through his own work as well as from collaborative efforts with other scientists and engineers.

  • Tyler Jacks, Ph.D. - Director, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology

5:15pm 6:00pm (45 mins)

Main agenda

BioPharma Executive Council Panel: Increasing Gender Diversity in BioPharma: What Works?

This panel on increasing gender diversity in the biopharma industry will focus on actionable strategies and programs that both men and women can work on together to help improve gender diversity in their companies. The emphasis will be on what everyone in our industry can do, whether at small, medium or large organizations, and at every level of their company to make a difference and deliver the benefits of gender diversity for corporate performance.

Actionable takeaways will include how to build programs for:

—Male Allies and Champions for Gender Diversity

—Flexible Work Policies

—Mentorship and Sponsorship Programs

Increasing gender diversity will be critical for continuing to build our innovative biopharma industry in the Boston area and to continuing to deliver economic growth to Massachusetts, so come hear what you can do to contribute in your own organization today.

  • Moderator Cissy Young, Ph.D. - Executive Director, Russell Reynolds Associates
  • Panelist Amri Johnson, Ph.D. - Global Head of Diversity and Inclusion, Novartis Institutes for Biomedical Research
  • Panelist Wei Moline - Vice President and General Manager, 3M Separation and Purification Sciences
  • Panelist Praveen Tipirneni, M.D. - President and CEO, Morphic Therapeutics, Inc.
  • Panelist Susan Windham-Bannister, Ph.D. - President and CEO, Biomedical Growth Strategies LLC

6:00pm 7:00pm (60 mins)

Main agenda

Diversity Networking Reception

6:30pm 9:30pm (180 mins)

Main agenda

Battle of the Biotech Bands

7:00pm 8:30pm (90 mins)

Main agenda

Women’s Leadership Dinner*

Sponsored by 3M

Connect with individuals in senior leadership positions and meet the rising stars in the life science industry at the first annual Women’s Leadership Dinner. Adele Gulfo, successful scientist turned business executive, will open the evening encouraging women to “stand on the edge” as leaders. Following Adele’s remarks, attendees will have the opportunity to engage in dynamic networking.

* Requires Festival PassPLUS or Separate Dinner Registration