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Biomanufacturing and Process Development (BPD)

Mission and Goals

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 2016-2017 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.

For more videos, visit our YouTube Channel.

 

Program Schedule 2016 – 2017 Season

Most events run from 1 to 5 p.m. at the North Carolina Biotechnology Center, 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.

**Monthly meeting and vendor sponsorship packages available. Request information.**

April 25, 2017

8 - 5 p.m.

Rapid PD Symposium & Vendor Show

Featuring speakers from Biogen, GE, PALL, KBI Biopharma, Sartorius Stedim and more!

“Approaches to accelerated process development with automation and analytics”
Len Blackwell, Sr. Scientist Analytical Development, Biogen
 
“High throughput cell line process development”
Kitty Agarwal, Sr. Scientist Cell Line Development, KBI Biopharma Inc.
 
“Accelerating upstream process development through the use of characterized automated scale-down models”
Kevin McHugh, ambr Taskforce Leader, Sartorius-Stedim, Inc.
 
“High throughput process development: optimizing a mAb chromatography polishing step”
Peter Hagwall, Product Manager, GE Healthcare
 
“Optimization of a continuous chromatography platform for antibody purification”
Xhorchi Gjoka, Pall Corporation
 
“Versatility, Speed, and Throughput in Bioprocess Development with Biolayer Interferometry”
Renee Tobias, Product Manager, Pall ForteBio
 
“The Need for Speed…Leveraging High Throughput to Accelerate Time to Clinic”
Juan Cueva, Associate Scientist III Downstream Process Development, Biogen

 

We would like to thank our featured sponsors:

GE Life Sciences & Roche Custom Biotech

We would like to thank our participating vendors:

Biolog, Molecular Devices, Pall, Pall ForteBio, Repligen, Sartorius Stedim, Tecan

 

 

 

May 3, 2017

12:30 - 4:30 p.m.

Bioprocessing of the Future Symposium

12:30pm:  Registration

1:00pm:  "Creating Capacity:  Innovative solutions for creating and expanding capacity in biological production"

David Radspinner, GE

1:45pm:  "The Path to Straight-Through Processing: Benefits, Challenges, and Enabling Technologies”
Ashton Lavoie, NC State University
Manufacturing costs represent a major barrier to the access to biotherapeutics by the global patient population. As the purification processes heavily impact the biomanufacturing costs, the development of affordable and more efficient purification technologies is a topic of growing interest. Platform processes in current downstream bioprocessing rely heavily on “bind-and-elute” chromatography, an inherently batch process that requires long processing times, significant buffer storage capacity, and often expensive chromatography resins. We propose an alternative purification paradigm, based on a “straight-through” process comprising only flow-through or continuous mode steps. In applying this strategy, the removal of host cell protein (HCP) is a primary concern, due to the wide variety of sequences and structures. As a result, our primary focus is the identification of novel approaches for the removal of HCPs in flow-through mode. A major challenge to this approach is the availability of high-throughput screening tools to track the log reduction value of each single HCP. In our recent work, we have adapted traditional proteomic analysis to evaluate removal of specific HCPs, and identify complementary technologies using validated statistical and graphical methods. Commercially available ion exchange and multimodal chromatography resins commonly used in bioprocessing were employed to demonstrate this methodology, allowing comparison of observed protein binding with an expected correlation between protein removal, as determined by LC-MS intensity-based absolute quantification (iBAQ), and theoretical isoelectric point (pI). In these studies, we have obtained expected statistically significant correlations between pI and protein removal over IEX resins in flow-through mode under physiological conditions. Additionally, we have identified potential resins to be used as a complementary pair in this system to support HCP removal, and flagged particular HCPs that bound weakly to all resins tested, allowing more targeted screening in subsequent steps to ensure their removal. This method will be used moving forward to evaluate the effectiveness of novel ligands in development for HCP removal.​​

2:30pm:  Break & Networking

2:45pm:  "Next Generation Manufacturing at Biogen"
Phil de Vilmorin, Biogen
Biogen​ has a promising pipeline and our existing facilities are running near capacity in support of the growing worldwide demand for biologics. Preparing for future success, Biogen is building a new large-scale manufacturing facility in Solothurn, Switzerland.  It will be Biogen’s largest facility, with a total mammalian cell culture capacity that may ultimately exceed 500,000 liters.  This presentation will introduce the next-generation operational strategies which will enable the Solothurn facility to deliver consistent product quality and unprecedented productivity.​​

3:30pm:  "Gene Therapy Considerations"
Josh Grieger, Bamboo Therapuetics
Adeno-associated virus (AAV) has shown great promise as a gene therapy vector in multiple aspects of preclinical and clinical applications. Many developments including novel serotypes, chimeric capsids as well as self-complementary vectors are now entering the clinic. With these ongoing vector developments, continued effort has been focused on scalable manufacturing processes that can efficiently generate high-titer, highly pure, and potent quantities of rAAV vectors.​

 

 

**Monthly meeting and vendor sponsorship packages available, request information**

Steering Committee Members 2016-2017

Hannah Cole North Carolina Biotechnology Center
Barney Crum F. Hoffman-LaRoche AG
Gary Gilleskie (Past Chair) Golden LEAF Biomanufacturing Training and Education Center (BTEC)
Damien Hallet Heat Biologics Inc.
Nathaniel Hentz Golden LEAF Biomanufacturing Training and Education Center (BTEC)
Stewart Kohnberg Thermofisher Scientific
Christine Megarity Pfizer Inc.
Elisa Newkirk Grifols Inc.
Brian Nunnally Biogen
Kimberley Parker  
Nikki Pavlides Pfizer Inc.
Shahid Rameez KBI Biopharma Inc.
Shraddha Shapariya (Chair)  
John Stefanyk EMD Millipore
Dhaval Tapiawala Pfizer Inc.
Kevin Williams North Carolina Central University
Kelly Wiltberger Biogen
Jennifer Zhang Biogen

 

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