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 and solutions. Students, trainees, and transitioning professionals are also encouraged to attend. The group meets approximately six to eight times a year with speakers from industry and academia, as well as technology and regulatory experts. This is one of the approximately 20 Exchange Groups that are supported statewide by NCBiotech.
Professionals, faculty, staff, students (undergraduate and graduate [MS, PhD]), postdocs, and industry members are welcome. There are no membership fees.
For the 2020-2021 season, 90-minute Zoom webinars (2 speakers) will be held from September through December 2020, with half or full day virtual symposia from January to May of 2021. Symposia will host multiple speakers centered around the meeting theme, and as time permits, include virtual breakout rooms for networking among attendees or discussion with exhibitors or speakers.
The Zoom online Half day symposia from approximately 12:30 to 5 p.m. and the Full day symposia will be held from ~ 9 am to 5 pm, unless otherwise noted. Registration is required for all webinars and symposia. Registration is currently FREE for all virtual symposia through May 2021.
BPD thanks our symposia sponsors who support our programs.
Click here to Request Information about webinars/symposia, sponsoring a webinar or symposium, as well as virtual exhibit opportunities as a sponsor or for vendor shows.
- Half Day Virtual Symposium Sponsorship $1000
- Full Day Symposia Sponsorship (includes virtual exhibit/break out room) $2000
- Full Day Symposium Virtual Exhibit/Breakout room $425
Program Schedule for the 2020-2021 Season
September 3, 2020 - Process Analytics and Automation Virtual Symposium
October 8, 2020 - "Vaccines Now!" Virtual Symposium
November 5, 2020 - "Diagnostics in Our Time of Covid-19" Virtual Symposium
December 3, 2020 - "Introducing Your Local Professional Biotech/Pharma Groups" Virtual Symposium
January 28, 2021 - BioGrow "Training and Education Across NC" Virtual Symposium
February 25, 2021 – Rescheduled to March 18th
March 18, 2021 – "Impact of Covid 19 on Supply Chain – A year into it and potential impacts to the Future"
*The Seqirus Vaccines program originally scheduled for this date has been cancelled.
April 22, 2021 - Cell and Gene Therapy Symposium and Full Day Vendor Show
May 20, 2021 - Regulatory and CMC
To be added to our mailing list, please fill out the Interest Form.
Steering Committee Members 2019-2020
Ronna Dornsife (Chair), North Carolina Central University/BRITE
Hannah Cole, North Carolina Biotechnology Center
Michael David, Eppendorf North America
Rosa Fernandez, NC BioNetwork
Karen Kast-Hutcheson, Repligen
Mark Mistretta, Watson Marlow Fluid Technologies
Ryan Moffa, Seqirus
Rob Onyenwoke, North Carolina Central University/BRITE
Thomas Parker, BridgeBio
Lawson Phillips, Seqirus
Caroline Smith-Moore, NC State University (BTEC)
Katie Stember, North Carolina Biotechnology Center
Dhaval Tapiawala, Pfizer
Alex Tracy, ISTARI Oncology Inc.
Robert Tyler, A&C Your Global GMP Partner
An Zhang, Biogen
The BPD Steering Committee thanks the following previous members of the steering committee for their contributions:
- Stewart Kohnberg (Past Chair)
- Rebel Umphlett
- Tara (Rutledge) Hamilton
- Stacey Traviglia
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 Opportunities 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
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
POSTPONED - May 5, 2020 - Process Analytics and Automation