BPI White Papers

Approach to Validation & Implementation of Single-Use Systems

While many of the reasons to move to single-use systems have been well defined over the last few years, there are still concerns with the lack of information regarding validation and implementation of the systems. In this on-demand educational webcast, Christopher Mach of Pall Life Sciences details the step-by-step approach to validation and implementation of single-use systems in biopharmaceutical manufacturing. You’ll learn about:

• A Summary of the Regulatory Position Regarding Validation
• Validation Program Key Points
• Pall Approach to Organizing and Operating an Appropriate Validation Program
• Pall Validation Capabilities

Join Mach as he utilizes a core study of extractables/leachables using the Pall AllegroTM Single-Use System to address industry concerns and help illustrate the necessary components of a successful validation program.

Increased Selection Criteria for Production Media

Operators of biotechnology facilities are facing an increase in selection criteria for production media – new ICH and FDA imperatives, new analytics and monitoring, platform production initiatives and more. In this on-demand webcast, William Whitford of Thermo Scientific discusses:

• Reasons for the Increase in Selection Criteria
• Particular Criteria Discovered by Thermo Fisher Scientific
• Application of how Criteria can be Resolved

Join Whitford as he introduces two studies performed at Thermo Scientific that demonstrate how selection criteria can be solved and resolved to provide transparency and ease for biotechnology and bio production operators.

Moving to the Next Level of Technology

The protein manufacturing industry faces many challenges today – large stainless steel bioreactors cause downstream processing bottlenecks and come with a large footprint and high CAPEX. To address these challenges, DSM Biologics has developed the XD® Process Technology. This proprietary technology uses disposable systems to simplify the downstream process and lower CAPEX. In this on-demand webcast, Rolf Douwenga, Vice President of Global Research and Development for DSM Biologics, discusses:

• Issues Facing Protein Manufacturing Industry
• How DSM Addresses These Issues
• In-depth Explanation of XD Process Technology

Join Douwenga as he details several case studies using XD Process Technology to enable a more flexible and simplified downstream process.

Advancing Cell Culture-Based Biopharmaceutical Programs using Metabolomics

Metabolomics is an approach for obtaining insight into the metabolism of a population of cells in a culture environment. As such, it has had particular utility in the area of upstream bioprocess optimization of biopharmaceuticals. In this on-demand educational webcast, Kirk Beebe of Metabolon illustrates the many uses of metabolomics for various bioprocessing activities, including:

• Cell Line Development/Clone Selection
• Targets for Pathway Engineering
• Media Development
• Process Optimization & Scale-up
• And more.

Join Beebe as he provides a deeper understanding of metabolomics technology and how it is helping to advance cell culture-based biopharmaceutical programs.

Perfusion! Jeopardy or the Ultimate Advantage?

In the past, perfusion methods were known to have high failure rates, but improvements in the technology have made perfusion more reliable. With newly improved technology and equipment, perfusion is now an efficient manufacturing process with the ability to reduce the cost of goods and capital investment required to bring a drug to market. In this on-demand educational webcast, Dr. Jason N. Carstens of CMC Biologics discusses:

• A Comparison Between Perfusion and Fed-Batch Methods
• Detailed Description of Perfusion Operations
• Advantages and Challenges of Perfusion

Join Dr. Carstens as he displaces old myths about perfusion and shows how this method of manufacturing can actually produce proteins that have more desirable product efficacy and safety profiles than would be possible with the fed-batch method.

Single-Use, Continuous-Countercurrent, Multicolumn Chromatography

Over the past decade, improvements in the biopharmaceutical manufacturing industry have resulted in a dramatic rise in the expression levels from animal cell cultures – some mAb titers have increased 30-fold over the last 15 years. However, increased titers have led to an increase in downstream bottlenecks. To address this challenge, some manufacturers are turning to multicolumn chromatography.

The principles of simulated moving-bed technology can be applied to create a continuous-countercurrent process. The first column in a loading train is allowed to break through, and material coming off it is captured on a second column. Binding capacity can thus be exploited beyond dynamic binding capacity. These processes often significantly improve media use – and hence significantly reduce consumption of media and buffers.

A Presanitized, Purpose-Designed, Single-Use TFF Strategy

As downstream processing accounts for about 70% of the total biomanufacturing cost, it is easy to see why improvements in product recovery and purification are urgently needed. One possible response to this need is the implementation of a single-use TFF process strategy.

Sius “single-use” cassettes provide a unique solution for a cost-effective downstream processing, with measurable cost-in-use savings, while eliminating a significant amount of time performing burdensome clean-in-place (CIP) procedures. This case study outlines the experimental design, development studies, and proposed single-use commercial TFF process based on work performed by Mike LaBreck at Groupe NovaSep.

Case Study: Evaluation and Implementation of a Single-Stage Multimedia Harvest Depth Filter for a Large-Scale Antibody Process

While in the process of transferring to a new manufacturing facility, scientists and engineers at Genentech, Inc. performed small-scale studies to evaluate several candidates for a single-stage depth filter train to accommodate existing equipment at the new facility.

After testing several dual-layer, single-stage filter media, the team chose a robust filter and implemented it at commercial scale. By replacing the traditional two-stage filtration train, they were able to provide significant cost savings relative to piping reconfiguration, new equipment purchase, and new equipment validation. To learn more about the testing methods and results of this study, download the PDF linked below.

FlexFactory from Xcellerex – A Proven Biomanufacturing Platform Enabled by Disposables

FlexFactory from Xcellerex is a biomanufacturing platform that is transforming the way the biotechnology industry approaches drug production. Built almost exclusively around disposables technology, each unit operation within the FlexFactory is self-contained in its own controlled environment module (CEM), effectively shrinking the cleanroom around each operation.

In this on-demand webcast, Parrish Galliher, Founder & Chief Technical Officer of Xcellerex, demonstrates how the FlexFactory eliminates the need for expensive clean-room facilities and CIP/SIP infrastructure, resulting in:
• Reduction in Capital Investment by 50% or More
• 70% Reduction in Start-up Time
• 55% Reduction of Carbon Footprint
• Major reduction of Water Consumption
• Increased Flexibility

FlexFactory is the only biomanufacturing platform that delivers the speed and capital efficiency of the CMO approach with the control and long-term economics of company-controlled manufacturing. View this webcast to gain an in-depth understanding of the benefits of this innovative technology.

Development of a High-Capacity MAb Capture Step Based on Cation-Exchange Chromatography

With new advances in expression vectors, the bioprocessing industry has seen a significant increase in antibody expression levels. To meet the demands of these increased titers, protein A chromatography columns need to be further scaled up in size and/or run in multiple cycles — with a consequent increase in buffer consumption, preparation, and storage. One way to address this problem is to develop other capture steps with high-capacity resins that can replace the protein A step.

This article outlines the methods and materials used to develop a high-capacity capture step using cation-exchange (CEX) chromatography to replace the existing protein A chromatography – making it possible to use existing chromatography hardware and eliminate increases in the buffer volume and holding tank size at existing manufacturing plants. Download the full article as a PDF below.