Biomanufacturing and Process Development

Biomanufacturing and Process Development (BPD)

BPD’s mission is to provide a forum for process development and manufacturing scientists and engineers to discuss bioprocessing issues. The group meets approximately eight to ten times a year with speakers from academia, industry, technology vendor experts, and regulatory experts. This is one of the 20-plus Exchange Groups that are supported statewide by NCBiotech.

Membership Guidelines

Faculty, students, postdocs and industry members with interest in BPD are welcome.

Meeting Format

Similar meeting format as previous years will be maintained in the 2018-2019 season. Each event will host multiple speakers centered around the event theme, allow a time for networking among attendees, and optionally include a vendor show or poster presentations.

Most events run from 12:30 to 5 p.m. at NCBiotech, unless otherwise noted. Registration is required for all seminars. Registration is $25 for industry/faculty, $5 for graduate/postdoctoral students and FREE for unemployed job seekers, unless otherwise noted.

Request information about monthly meeting and vendor sponsorship packages.

For other information, contact Nikki Pavlides.

 

Program Schedule for the 2018-2019 Season

September 2018 - Networking Facility Tour*

*KBI Biopharma

 

October 24th, 2018 - Future of Manufacturing Symposium and Vendor Show

"The Use of Bio-capacitance to Improve Consistency in Cell Culture Processes" 
Taylor Forte, engineer I, Cell Culture Development, Biogen

"Platform 2.0?" 
Keith Selvitelli, scientist I, Process Biochemistry, Biogen

"Inspiring Advances in Bioprocessing" 
Mario Sinani, field application specialist, Repligen

"Implementation of Protein A Multi-Column Chromatography at Process Scale"
Denis Kole, senior principal scientist, Biopharm SLS, Continuous Bioprocessing, Pall

"Innovations Drive Changes in Antibody Purification Systems"
John Jenco, senior bioprocess applications scientist, GE Healthcare

"Application of Single Pass TFF to Enable Intensified and Continuous Biological Manufacturing" 
Josh Arias, MilliporeSigma

 

November 29, 2018 - Novel Modalities Symposium

“Preparing for the Future Growth of Oligonucleotide Therapies”
Sheron Branham, MBA, associate director, ASO Process Engineering and Manufacturing, Biogen

“Scaling Up of Stem Cell Production for Research and the Clinic”
Barbara Ressler, Ph.D., director, Cell Therapy Product Development, Marcus Center for Cellular Cures, Duke University

"A Rapid Affinity Purification Technology and Supply Platform to Address the Manufacturing Complexities of Novel Modalities"
Dan Freymeyer, head of business development, Avitide Inc.

"Challenges in Allogenic CAR T Cell Manufacture"
Kim Nguyen, director, Process Development, Precision BioSciences

 

January 17, 2019 - Education and Training Spotlight

Introductory presentation: “The Biopharmaceutical Training and Education Landscape in North Carolina”

Panel discussion: "Faces of Success"  
Former students from local educational programs will discuss how these programs helped to prepare them for a career in the biopharmaceutical industry.

Panel discussion: "Path to Success"  
Hiring managers will share their views on skills needed for a successful career in the biopharmaceutical industry.

There are several opportunities to network with training/education organizations at booths.

Participating organizations:
BTEC (at NC State University), BRITE (at NC Central University), BioNetwork, East Carolina University, BioWork Program, Campbell University, ISPE, NCBiotech, Vance-Granville Community College, Wake Technical Community College

 

March 7, 2019 - Product Life Cycle Strategies Symposium

"Phase in and Phase out of new portfolio solutions- Knowing when to make the jump"
Brenda Beauchamp, bioMerieux

"Getting good at change - leveraging your domestic products internationally and doing it well"
Brandon Buchanon, Novo Nordisk

"Biologic Products LCM: New indications, New formulations, New routes of administration, New markets"
Dee Parson Grange, Grifols

"Fulfilling the promise of regenerative medicine through lifecycle improvements"
Alex Tracy, Enzyvant

 

April 11, 2019 - Cell and Gene Therapy Symposium and Vendor Show

Cell Therapy (10:00 - 11:45 am)

“Manufacturing Solutions Driving Rapid Clinical Translation of hMSCs and hMSC-Based Therapeutics”
Priya Baraniak, Ph.D., Senior Director, Business Development ROOSTER BIO

“Steps to Reduce Bioburden from Human Livers during Manufacturing of Hepatocytes”
Jeremy Smith, B.S., Head of Quality Control, PROMETHERA

“Off the Shelf Chimeric Antigen Receptor (CAR) T Cell Therapy for the Treatment of Cancer”
Mark Johnson, Ph.D., Team Leader, Cell Therapy Discovery, PRECISION BIOSCIENCES

Gene Therapy (1:25-3:20 pm)

“Regulatory Obstacles for Starting Cell and Gene Therapy Trials”
Stephanie Pierce, Ph.D., RAC, Regulatory Affairs Scientist, OFFICE OF REGULATORY AFFAIRS AND QUALITY, DUKE UNIVERSITY SCHOOL OF MEDICINE

“Adeno-Associated Virus Biology and Bioprocessing”
William (Billy) Kish, Ph.D., Senior Scientist, Gene Therapy Process Development, PFIZER (BAMBOO)

“Innovation in AAV Manufacturing - Vertical Integration and Continuous Improvement”
Jacob Smith, B.S., Director of Process Development, ASKBIO

We'd like to thank our participating vendors:

ACGT, Inc. Applikon Biotechnology, Beckman Coutler Life Sciences, Bio-Rad, Charles River, Charter Medical, Kymanox, Pall Biotech, PBS Biotech, STI, Synthego, Waston Marlow, and Waters

Register Here

 

May 9, 2019 - Comparability/Characterization Symposium

 

 

**Monthly Meeting and Vendor Sponsorship Packages available, for more information, contact Hannah_cole@ncbiotech.org**

 

Steering Committee Members 2018-2019

  • Hannah Cole, North Carolina Biotechnology Center

  • Stewart Kohnberg, Tokyo Chemical Industry Co., Ltd.

  • Nikki Pavlides, Ph.D., Kymanox

  • Michael David, Eppendorf 

  • Ronna Dornsife, NCCU BRITE

  • Gary Gilleskie, NC State University (BTEC)

  • Karen Kast-Hutcheson

  • Zach Koontz, Waters Corp.

  • Thomas Parker, MilliporeSigma

  • Shraddha Shapariya

  • Caroline Smith-Moore, NC State University (BTEC)

  • Stacey Traviglia, Ph.D., Biogen

  • Matthew Tyson, Duke Human Vaccine Institute

  • Kevin Williams, NCCU (BRITE)

  • Jennifer Zhang, Biogen

To be added to our mailing list, please fill out the Interest Form.