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.
Faculty, students, postdocs and industry members with interest in BPD are welcome.
Similar meeting format as previous years will be maintained in the 2019-2020 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.
Program Schedule for the 2019-2020 Season
October 17th, 2019 - Continuous Manufacturing: Upstream and Downstream Symposium & Full Day Vendor Show
"Continuous Manufacturing, Upstream and Downstream: The Future is Here, But Do You Want it?"
Herman Bozenhardt, President at Bozenhardt Consulting
“Continuous Manufacturing from Perfusion to Capture Step”
Mike Ford, Engineer I, DS Pilot Protein Development, Biogen
“Continuous Inline Concentration and Capture Step at Pilot Scale”
Sanaa Elouafiq, Associate Scientist III, Biogen
“Batch to Continuous: Post-Approval change for ProA step”
Sandhya Manjunath, Senior Scientist Continuous Bioprocessing, Pall
"Affinity Chromatography: A corner stone of the integrated continuous bioprocessing”
Kevin Isett, CEO, Co-Founder, Avitide
“Process Concepts with Brilliant Potential for Connected & Continuous Biomanufacturing”
Avril Vermunt, Program Manager, Connected Biomanufacturing, GE Healthcare
“Designing today for the future of continuous processing”
Erich Bozenhardt, Process Manager, IPS-Integrated Product Services
November 20th, 2019 - Innovations in Fermentation
“Building Upon Fermentation Excellence”
Timothy Cooper, Novozymes
“Novel products from the crop and soil microbiome for agriculture and beyond”
Dr. Kelly Smith, AgBiome
"Leveraging Models and Process Knowledge to Enable Accelerated Development into Manufacturing"
Jason Fairlee, Fujiflim Diosynth
Panel Discussion: Fermentation Across Industries
Moderator: Dr. Paul Ulanch, North Carolina Biotechnology Center
Panel Participants include:
- Dr. Andrew Turner, Vecino Brewing Company
- Timothy Cooper, Novozymes
- Tony Fulz, Fujifilm Diosynth
- Dr. Kelly Smith, AgBiome
- Ying Yang, Eppendorf
December 12th, 2019 - Challenges and Oppourtunities in Rare Diseases
“CMC Development and Regulatory Challenges for Rare Diseases: Case Studies for an Individual Patient Expanded Access IND for Glioblastoma and Rare Genetic Disease BLA”
Tracy TreDenick, Head of Regulatory & Quality, BioTechLogic
“A Text Mining Approach to Drug Repurposing for Rare Diseases”
Weifan Zheng, Ph.D., Associate Professor, Department of Pharmaceutical Sciences, BRITE Institute, NC Central University
"Manufacturing Products for Rare Diseases: Regulatory and CMC Considerations"
Amanda Parrish, Head of Quality & Regulatory, Duke University
February 5, 2020 - Sourcing, Selection and Quality of Raw Materials
“Qualification of Raw Materials and Cell Substrates for Biomanufacturing”
Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia
“Raw Material Characterization and Control”
Thomas Matthews, Ph.D., Scientist II, Manufacturing Sciences, Biogen
"Ancillary Materials for Cell and Gene Therapy Products- Regulatory Challenges"
Kamalpreet Arora, PhD, Senior Consultant, Chemistry Manufacturing and Control, Biologics Consulting
March 3, 2020
BioGrow: Training and Continuing Education Across NC
Why attend? To learn more about outstanding North Carolina education and training opportunities in the area of biopharmaceuticals.
Who should attend? Students of all ages and educational levels, including community college students, university students, and professionals looking for educational opportunities to enhance your career.
Participating organizations: BTEC (at NC State University), BRITE (at NC Central University), BioNetwork, East Carolina University, BioWork Program, Campbell University, NCBiotech, Alamance Community College, Durham Technical Community College, Forsyth Technical Community College, Johnston Community College, Piedmont Community College, Wake Technical Community College
Faces of Success - Former students from local educational programs will discuss how these programs helped to prepare them for a career in biopharma
Moderator: John Balchunas – NC State
Dominique Wright – former JCC student, currently works at ThermoFisher Scientific
Stefanie McCloskey – former BioNetwork student, currently works at Catalent Pharma Solutions
Srujan Bhagwat - former BTEC student, currently works at Integrated Project Services (IPS)
Chidindu Nkwazema - former BRITE student, currently works at AveXis
Tonya Mosely – former Alamance CC student
Asia Johnson – former Durham Tech and NCCU student
Path to Success - Hiring managers will share their views on skills needed for a successful career in biopharma
Moderator: Brenda Summers – NCBIO
Wade Smedley – HRBP Site HR Leader, Merck
Blake Derrick – Sr. Talent Acquisition Consultant, Seqirus
George Kafes – Director of Talent Acquisition - Quality Organization (U.S. Sites), AveXis
Tricia Jennings - Manager, Vector Manufacturing, bluebird bio
POSTPONED - April 1st, 2020
Cell and Gene Therapy Symposium and Full Day Vendor Show
As of 2020, cell and gene therapy companies are becoming a significant portion of the new biopharma/biologics business landscape in North Carolina. Some are spinouts from NC universities, manufacturing operations from small-to-medium size companies based elsewhere in or outside the US, as well as development and manufacturing in established larger biopharma companies as a result of purchased start-ups and/or adding in-house expertise to expand into this fast-moving and competitive field. Come find out about the latest technical developments from presentations by Pfizer, BridgeBio, Cellectis, AskBio, Precision Biosciences, and AveXis. More than a dozen vendors are expected to exhibit equipment, tools, and services. Come learn and network with others working on these processes and novel products (lunch included)!
POSTPONED - May 5, 2020
Process Analytics and Automation
**Sponsorship Packages available, for more information, contact Hannah_Cole@ncbiotech.org**
Steering Committee Members 2019-2020
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
Tara Hamilton, Bionetwork
Karen Kast-Hutcheson, Pall
Zach Koontz, Waters Corp.
Thomas Parker, MilliporeSigma
Caroline Smith-Moore, NC State University (BTEC)
Stacey Traviglia, Ph.D., Biogen
Mark Mistretta, Watson Marlow Fluid Technologies
Rob Oyenwoke, NCCU
Katie Stember, NCBiotech
Dhaval Tapiawala, Pfizer
Alex Tracy, Enzyvant
Rebel Umphlett, BioNetwork
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