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 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.

Membership Guidelines

Professionals, faculty, staff, students (undergraduate and graduate [MS, PhD]), postdocs, and industry members are welcome. There are no membership fees.

Meeting Format

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.

Sponsorships

  • 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

CONTACT: Hannah_Cole@ncbiotech.org

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

Featured Panels:

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 

     Panelists:

     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

     Panelists:

     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