Boston Biotech Week is Here – Don’t miss our exciting coverage of the event

Boston Biotech Week begins September 4th in Boston. The conference is focused on providing companies the opportunity to share ideas, strategies and solutions to overcome challenges at every stage of development. Cell Culture Dish/Downstream Column will be attending and blogging from the event. Please don’t miss our related blogs over the next month.

Wednesday September 5th, 9:05-9:30

We are excited at Cell Culture Dish to be chairing a panel discussion  Cell and Gene Therapy Bioprocessing and Commercialization Conference. The panel titled, Key Considerations in Gene Therapy Manufacturing for Commercialization, will focus on gene therapy manufacturing, including the latest in manufacturing methods, analytical analysis and key regulatory considerations. Topics to be discussed include:

  • Planning for scale up, technology transfer and regulatory considerations on the way to commercialization.
  • In-house vs. Outsourcing manufacturing.
  • Ensuring scalability and efficient timelines in manufacturing while still maintaining reasonable cost.
  • Analytical Development
  • Where are we at as an industry and where is there room for improvement.

If you are attending, don’t miss these exciting talks and activities!

Interesting Talks in Each Track. Here are some examples:

Keynote Presentations

A Vision for Rare Disease: How We Can Champion Underserved Patients
Flemming Ornskov, M.D., MPH, Chief Executive Officer, Shire

Synthetic Biology: Biomedical Applications Come of Age
James Collins, Ph.D., Termeer Professor of Medical Engineering & Science and Professor, Department of Biological Engineering at Massachusetts Institute of Technology

Tools for Mapping and Repairing Disease States: Can We Make Therapeutic Invention into a Mature Design Science?
Ed Boyden, Ph.D., Termeer Associate Professor, Media Lab and McGovern Institute Departments of Biological Engineering and Brain and Cognitive Sciences at Massachusetts Institute of Technology

Genomics, Advanced Imaging and the Future of Medicine
J. Craig Venter, Ph.D., Co-Founder, Executive Chairman, Head of Scientific Strategy at Human Longevity, Inc.

The Convergence Model of Cancer Research: Solving the Problems of Cancer through Interdisciplinary Approaches
Tyler Jacks, Ph.D., Director, Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology

Building Value Through External Stakeholder Engagement
Liz Lewis, Chief Counsel and Head of Patient Advocacy at Takeda Oncology

Cell Culture Dish and Downstream Column Sponsor Activities:

BD Biosciences – Booth 620

Beckman Coulter – Booth 227

Bio-Ess Laboratories, LLC – Booth 423

See new data on Cell-Ess universal titer boost presented by CSO Dr. Adam Elhofy at Posters:

    • Glycolytic Complexity and Pattern Consistency can be Improved by Using a Novel Supplement and Feed – Poster #C33
    • Novel Approach to Production of Influenza in Minimal to No Serum – co-published with FujiFilm Poster #C32

Cell Culture Company– Booth 426

Charter Medical – Booth 1229

Talk: Dominic Clarke, Ph.D., Global Product Manager, Charter Medical will be a panelist on Tuesday, September 26th at 2:15

PANEL DISCUSSION: We Need to Talk about Particulates, Leachables and Extractables

  • Discussing strategies used for the identification and control of particulates, leachables and extractables
  • Evaluating the need for new technologies, methods and strategies
  • Addressing particulates, leachables and extractables given a lack of regulatory guidance / specifications
  • Assessing the importance come the clinic

Corning – Booth 411

Corning is announcing their new collagen dissolvable microcarriers, a revolutionary advancement in cell expansion technology.

Technology Workshop:

John Huyhn, Ph.D., Director of Clinical Manufacturing at the University of Pennsylvania, will describe his approach for successfully scaling AAV production for Gene Therapy on September 27 at 12:00 p.m.

Finesse – Booth 526

Fujifilm Diosynth Biotechnologies  – Booth 910


Wednesday September 27th at 1:30, BPI Theatre

The Saturn mAb Platform: High Throughput Monoclonal Antibody Development and Manufacturing

Dr. Patrick Robertson, Director Program Design

Fujifilm’s Saturn Platform offers de-risked, rapid and reliable development and cGMP manufacturing for mAbs. The platform encompasses process assessment, analytical development and manufacturing using dedicated facilities with standardized equipment, raw materials and consumables to which increases efficiency and reduces cost, lead times and risk. Saturn programs can start with Fujifilm’s Apollo s cell line or with client cell lines.

Wednesday September 27th at 3:00

Comparison of adherent cell technologies for the amplification of virus stocks and viral vectors

Dr. Steve Pincus, Associate Vice President, Virology & Analytical Methods Development

The production of high titer viral vectors for large scale vaccine production affords many challenges. Often it is difficult translation to make mammalian adherent cells from small laboratory scale to the much larger manufacturing scale. In this study we examine several of the available technologies for their ability to support adherent cell growth as well as virus production. The parameters we evaluated in this study include cell growth, virus production, infectious virus and virus yield per cell.

GE Healthcare Life Sciences – Booth 207

Preconference symposia:
Advanced control strategies in bioprocessing and biomanufacturing: disruptive technologies and emerging platforms for biologics facilities of the future
Mon. Sept. 25 | 9 am
By: Bill Whitford, Strategic Solutions Leader, Cell Culture, Bioprocess, GE Healthcare

Evaluation of next-generation protein A chromatography resin for the purification of monoclonal antibodies
Thu. Sept. 28 | Noon
By: Bryan Dransart, Senior Research Scientist, Gilead Biosciences Recover and purification track

Technical posters:

  • Evaluation of ÄKTA™ readyflux for ultrafiltration to high protein concentration
  • A next-generation protein A resin for improved productivity and bioburden control
  • Characterization of Xcellerex™ single-use bioreactor systems
  • Development of a perfusion process with automated control of the biomass

Technology workshops:
Cell culture perfusion doesn’t need to be complicated
Tue. Sept. 26 | 11:50 am
By: Yasser Kehail, Global Bioprocessing and Analytics Product Manager, GE Healthcare

The critical role of automation in CAR T cell manufacturing

Tue. Sept. 26 | 11:50 am
By: Rodney L. Rietze, Process Innovation and Strategic Development, Novartis

Outsourcing process development in the bid to bring rare therapies to clinic faster
Wed. Sept. 27 | 12:05 pm
By: Alex Tracy PhD, VP of Pharmaceutical Development and Manufacturing, Roivant Sciences Inc.

Addressing the risk of bioburden and the need for increased productivity in protein A chromatography
Thu. Sept. 28 | 7:30 am
By: Jonathan Royce, Senior Product Manager, GE Healthcare

Thirty years of mAbs and protein A: a retrospective look at 30 years of synergies
Thu. Sept. 28 | 9:50 am
By: Geoff Hale, Managing Director, Bioarchitech

For more details, please see – BPI Flyer

Irvine Scientific  – Booth 1123

Technology Workshops:

Tuesday, 26 September 2017 11:50am – 12:20pm

The Development of Animal-Component-Free, Chemically-Defined Culture Media for Immune Cells

Wednesday, 27 September 2017 12:05pm – 12:35pm

Control Glycosylation and its Functional Impact on Therapeutic Antibody

JSR Life Sciences  – Booth 513


  • Case study of a continuous capture step of a monoclonal antibody downstream process – Kaori Itaya, R&D engineer
  • A Novel Chromatographic Technology: Enhancing performance Utilizing a Modular, Lattice Supported Resin Bed – Masayoshi Nagaya, Sr. Global Technology Manager
  • New affinity resins for Fab fragment antibodies purification – Takashi Matsuda Ph.D, R&D Manager
  • New Protein L Affinity Resins for Antibody Fragments Purification – Masaaki Hanamura Ph.D., R&D Manager

Kaneka – Booth 607

Kerry  – Booth 421

MaxCyte  – Booth 724


Cell Culture & Upstream Processing
Thursday, 28 September 2017 9:15am – 9:45am

Keys to Accelerated Production of the Right Protein from the Right Cells, Presenter: Joan Hilly-Foster


Fast Tracking Biotherapeutic Development Using Flow Electroporation Technology for Large-scale Transient Expression, Cell Line Generation and Genome Modification.

MilliporeSigma – Booth 211


Innovative Chromatography Technologies to Enable Next Generation Downstream Processing of Monoclonal Antibodies

September 26, 9:15 a.m., Room 306

James G. Stout, Vice President, Natrix Separations

Cell Culture Medium Designed for Perfusion Process: Case Studies and Impact on Upstream Process Economy

September 26, 11:15 – 11:45 a.m., Room 304

Delia Lyons, MSc. Senior Scientist, Head Perfusion Media Development

Virus Safety for Vaccines, Viral Vectors, and Cell Based Therapies

September 26, 11:50 a.m. – 12:20 p.m., Room 204

Damon Asher, Head of MilliporeSigma Americas Vaccine Initiative

Investing in Process Development for Increased MSC Production in Stirred Tank Bioreactors

September 26, 1:45 – 2:15 p.m., Room 210

Julie Murrell, Ph.D., Head of Cell Therapy Bioprocessing

Risk Reduction and Economic Considerations for Implementing Upstream Virus Filtration

September 26, 2:15 – 2:45 p.m., Room 308

Michael Cunningham, Ph.D., Associate Director, Applications Engineering, MSAT

Visit the MilliporeSigma website for more information on activities at BPI.

Molecular Devices – Booth 216

Technology Workshop:

Time: Tuesday, September 26, 11:50am – 12:20pm

A microfluidics-based single cell isolation workflow optimized for efficiency, viability, and assurance of monoclonality

Steve Wiltgen, PhD, Product Manager, Molecular Devices


A microfluidics-based single cell isolation workflow optimized for efficiency, viability, and assurance of monoclonality

Nucleus Biologics – Booth 514

Pall Life Sciences – Booth 219 & 319

September 25th

Continuous Processing
9 am:  Chairman’s Opening Remarks
(Peter Levison, Ph.D. – Senior Marketing Director, Downstream Processing, Pall Life Sciences)

9:15 am:  Perspectives on Continuous Processing
(Howard Levine, Ph.D. – Founder, President and Principal Consultant, BioProcess Technology Consultants)

9:45 am:  Pilot-Scale Perfusion and Clarification Using Multidimensional Acoustic Wave Perfusion Device
(William Napoli – Scientist, Bioprocess Technology and Expression, BioProcess Development, Merck & Co., Inc.)

10:45 am: Cadence Acoustic Separator and Implementation Potential for Mammalian Harvest or Continuous Processing
(Daniel LaCasse – Principal Scientist, BioTherapeutics R&D, Purification Process Development, Pfizer)

11:15 am: Approaches to Improving Chromatographic Productivity: Scale Up Evaluation
(Lindsay Arnold – Scientist, BioProcess Engineering, MedImmune)

11:45 am: 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.)

1:30 pm: Chairman’s Remarks
(Marc Bisschops, Ph.D. – Senior Principal Scientist, Continuous Processing, Pall Life Sciences)

1:45 pm: Continuous Diafiltration Using Countercurrent Staging
(Andrew Zydney, Ph.D. – Professor and Department Head, Chemical Engineering, The Pennsylvania State University)

2:15 pm: Economic Evaluation of Continuous Downstream Bioprocessing
(Mark Schofield, Ph.D. – Principal R&D Engineer, Pall Life Sciences)

3:15 pm: Panel Discussion: Debottlenecking Batch Processes by Adopting Continuous
(Peter Levison, Ph.D. – Senior Marketing Director, Downstream Processing, Pall Life Sciences)

4 pm: Continuous BioManufacturing: Past, Present, and Future
(Sadettin Ozturk, Ph.D. – SVP, Process and Analytical Development, MassBiologics)

4:30 pm: A Look at Reality: The Short-term Outlook for Continuous Manufacturing of Biologics
(Jeff Odum – Global Technology Partner, Strategic Manufacturing Concept Group, NNE)

September 27th

Viral Safety Track

8:10 am: Viral Safety – Chairperson’s Remarks
(Morven McAlister, Ph.D. – Senior Director, Pall Life Sciences)

8:45 am: Virus Filtration in Continuous Bioprocessing
(Morven McAlister, Ph.D. – Senior Director, Pall Life Sciences)

Cell Culture Recovery and Purification Track

8:15 am: Acoustic Wave Separation as a Novel Clarification Technique for the Removal of Aggregate–Enriched Calcium Phosphate Precipitates During Bispecific Antibody Purification
(Lindsay Arnold – Scientist, BioProcess Engineering, MedImmune)

1:55 pm: Cell Culture & Upstream Processing / Recovery & Purification Shared Session: Case Studies and Lessons Learned
Chairperson’s Remarks
(Peter Levison, Ph.D. – Senior Marketing Director, Downstream Processing, Pall Life Sciences)

3:00 pm: An Update on Significant Technology Advances Enabling Integrated Continuous Bioprocessing
(Michael Egholm, Vice President, Biopharmaceuticals, Pall Life Sciences)

For more information, please visit Pall’s BPI Event website

Purolite – Booth 1323

Praesto ‘Jetted’ Agarose Resins

Discover Purolite Life Sciences’ latest Praesto ‘jetted’ agarose resins.  These resins are manufactured to demonstrate enhanced performance characteristics including: better pressure/flow properties, improved resolution, and tighter bead size specifications.  For further information or to discuss your purification challenges, come visit booth 1323.

For more information, please see –Purolite BPI Flyer

Roche Custom Biotech – Booth 619 & 1205

Come visit Booth 619 to learn about new products and solutions for Upstream and Downstream Bioprocessing.

Come visit Booth 1205 to learn about new products and solutions for Cell Therapy Manufacturing.

Thermo Fisher Scientific – Booth 911

Vironova – Booth 709

Technology Workshop:

Tuesday, 26 September 2017 11:50am – 12:20pm

Meaningful Insights on Subvisible Particle Morphology, Size and Purity

Electron Microscopy (EM) together with image analysis give unmatched insight on sample purity, particle stability and morphological characteristics. This case study shows how a table-top MiniTEM system developed by Vironova is used to automatically detect undesired process outcome such as debris, broken particles and aggregates. Purity and integrity of AAV and Adenovirus Gene Therapy vectors samples are measured automatically in about one hour.

Mathieu Colomb-Delsuc, Ph.D., Senior Scientist, Electron Microscopy Technologies at Vironova

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