What's New in Single-use, Continuous and Flexible Bioprocessing Industry case studies
Jun 19, 2018
09:00 AM EDT
At Repligen bioprocessing seminars, thought leaders and professionals from around the world meet and review exciting new drivers of bioprocessing efficiency, learn from adopters of transformative technologies, evaluate risk landscapes and collaborate to help set the standards for modern bioproduction.
Agenda
Registration and Coffee
Welcome and Overview
Using an Integrated Design Approach in Upgrading an End-to-End Sigle-use Drug Substance Facility to be Commercial Manufacturing Ready (Case Study)
Dr. Carnley Norman, Vice President, KBI
Abstract
The talk will cover using a strategic approach in leveraging process development planning and facility fit (Monte Carlo analysis) to design a flexible commercial manufacturing end-to-end single use facility to produce 10 KG of BDS per batch. Additionally, the presentation will discuss starting up the drug substance manufacturing facility with support systems (buffer preparation, WFI generation/ distribution system) in an expedited fashion to minimize manufacturing down time.
Speaker Bio
Dr. Carnley Norman is the Vice President of Manufacturing Operations at the KBI Biopharma Durham Mammalian Cell Culture Manufacturing site. Dr. Carnley has over 18 years of therapeutic protein drug substance and vaccine process development, characterization, technology transfer and manufacturing experience with KBI Biopharma, Novartis, Astra Zeneca (MedImmune), Amgen and Merck. Prior to joining KBI in 2014, he led and managed the Manufacturing Science and Technology (MS&T) purification groups at Novartis Vaccines (Lab and MFG Support groups) focusing on process validation, technology transfer, manufacturing support process optimization/improvement in support of flu cell culture manufacturing. He also represented MS&T on the Flu Cell Culture Bulk Operation Leadership Team. During his career, Carnley held technical leadership roles for 9 new product introductions to commercial manufacturing sites including 4 new drug substance facility start-up projects. Two of these projects won ISPE Facility of the Year Awards. He also led process modeling initiatives at Amgen, MedImmune and Novartis. This includes facility simulation, fit-to-plant related modeling and equipment modeling using computational fluid dynamics (CFD). Carnley received his Ph.D. in Chemical Engineering from North Carolina State University with a Minor in Business Management (concentration in Technology Transfer).
Nove; Filtration Solutions in Bioprocessing: A Case Study for Adopting Single-use Technologies at a CRO
Brent Cope, Downstream process Development Scientist, FUJIFILM Diosynth Biotechnologies
Abstract
Facilities built around single-use technologies offer the potential for providing earlier access to cGMP manufacturing and disposition, allowing FujiFilm’s partners to meet critical timelines in their CMC journey. TangenX™ single-use TFF cassettes offer the performance of reusable cassettes with single-use convenience at a fraction of the time and cost. Here we will discuss the implementation of the single-use cassettes in our Saturn mAb platform process.
Speaker Bio
Brent Cope is a Downstream Process Development Scientist at Fujifilm Diosynth Biotechnologies in RTP, NC where he has worked since 2007. He has over 11 years of experience working in Downstream Process Development including early and late stage development, tech transfer, and manufacturing support. Brent holds a Bachelor’s of Science in Pharmaceutical Science and a Master’s of Science in Pharmaceutical Science/Bioprocessing & Biotechnology from Campbell University.
Scaling Up? No Problem with New 80cm Diameter Pre-packed OPUS® Column
Adam Nelson, Technical Support Specialist - OPUS, Repligen
Abstract
The technical and economic benefits of ready-to-use, pre-packed chromatography columns have been proven and documented. The question remains, how large can we go? This presentation will show how the unique OPUS® pre-packed column design delivers excellent chromatographic performance, and how usage can result in operational risk reduction as well as substantial cost savings for clinical and commercial scale manufacturing.
Speaker Bio
Adam Nelson is the OPUS® Technical Specialist within the Product Management group at Repligen. Adam is a bioprocess engineering professional who brings over 7 years of expertise in chromatography column packing and operation. Adam joined Repligen’s pre-packed column manufacturing division in 2010. In 2017, Adam transferred to the role of Product Support Engineer where he assisted in special manufacturing, development, and improvement projects for the OPUS® product line. Adam holds a Bachelor’s of Science in Chemical Engineering from the University of Massachusetts, Amherst.
Lunch and Networking
Performance and Economic Advantages of Single-use Flat Sheet Tangential Flow Filtration
Michael LaBreck, Bioprocessing Sales Specialist, Repligen
Abstract
Implementation of single-use alternatives in tangential flow filtration (TFF), a critical step in concentration and diafiltration (buffer exchange), is becoming platform in downstream bioprocessing. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This presentation will demonstrate how deploying these innovative cassettes can help reduce filter cost by 80%, reduce labor costs by 50%, and reduce buffer and water usage by 75% when compared to traditional reusable cassettes.
Speaker Bio
Michael LaBreck is Bioprocessing Sales Specialist for TangenX™ TFF products at Repligen starting in December 2016. Before that, he supported the TangenX™ product line at NovaSep 2008- 2016. He has over 20 years experience with tangential flow filtration applications support in the biopharmaceutical industry. He has held various sales and applications engineering positions with Pall Corporation and GE Healthcare. Michael has a Bachelor of Science degree in Mechanical Engineering from Syracuse University.
Applications of Pre-packed Columns in Scale Down Model and Viral Clearance Validation Studies
Nathan Nicjoles, KBI Biopharma
Abstract
Viral clearance studies and scale down model development require a significant number of columns with known bed height and column performance characteristics. Use of pre-packed columns for these studies represents an opportunity for significant time savings over packing columns in house for these critical studies.
Speaker Bio
Nathan Nicholes is a Downstream Process Development Scientist at KBI Biopharma in RTP, NC where he is involved in early phase process development, scale down model development, tech transfer and viral clearance studies in support of client projects. Dr. Nicholes received a BS in Chemical Engineering from the University of Oklahoma and a PhD in Chemical Engineering from Johns Hopkins University.
Break
Need for Speed: Positive Impact of Pre-packed Columns in Early Stage Clinical Bioprocessing
Rob Ballard, Process Engineer III, Biogen
Abstract
Pre-packed chromatography columns have been employed in Biogen’s Flexible Volume Manufacturing (FVM) facility since its inception in 2012. Through periods of start and stop production over the last 6 years, there have been several opportunities to reassess the advantages and challenges in implementing pre-packed columns. While a premium is paid for an external pack, 100 FTE hours and two weeks of clean space usage between each campaign is saved. These benefits allow FVM to remain true to its on-demand model leading to fast R&D transitions and quick production of early phase clinical material.
Speaker Bio
Rob Ballard is the lead engineer in Biogen’s early phase clinical manufacturing facility, Flexible Volume Manufacturing (FVM). In this role, he has been involved with equipment and automation troubleshooting, designing single use consumables, implementing new technology into the facility, leading process transfers, and performing hands-on manufacturing operations. Previous to FVM, he worked within the stainless manufacturing facility in the upstream cell culture area as well as in automation engineering. Rob has been with Biogen since 2010 and holds a Bachelor of Science degree in Chemical Engineering from N.C. State University.
Downstream Hollow Fiber Filtration Techniques for Novel Biological Modalities: Case Study on Exosomes
Sara Busatto, Ph.D Candidate, Nanotechnology and Extracellular Vesicles Group, Mayo Clinic
Abstract
Extracellular vesicles (EVs) are cell-secreted nanoparticles that play a pivotal role in intercellular communication that affects both physiological and pathological processes. Therefore, EVs have great potential for diagnostic and therapeutic applications. However, the major challenge that hampers the use of EVs for medical applications is reproducible and scalable isolation. Tangential flow filtration represents a promising technique for the separation of EVs from various biological fluids.
Speaker Bio
Sara Busatto is a visiting Ph.D. student in Dr. Wolfram’s nanotechnology and extracellular vesicles group at Mayo Clinic, Florida, USA. Her research focuses on exploring the targeting and drug delivery capacity of extracellular vesicles in vitro and in vivo. At Mayo Clinic she is studying the interface between EVs and biological membranes, especially focusing on the blood brain barrier. She has several publications in the field of extracellular vesicles. Her goal is to foster and contribute to the progress of a personalized and biocompatible nanomedicine, translatable in new and more effective therapies for the treatment of pathologies which to date have no cures. Busatto holds a Master’s Degree in Medical Biotechnology from the University of Brescia in Italy.
Wrap up
Cocktails and Networking
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