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 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

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

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

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