BPI White Papers

pDNA Production and Purification

In recent years, there has been a growing demand for DNA-based therapeutics, commonly known as gene therapy, to combat genetically-based pathologies. Because plasmid DNA have significantly different biophysical characteristics than proteins, their production can have a drastic impact on downstream purification unit operations. Join Dr. Stephen Palmieri and Dr. Jesse McCool of Lonza Biologics and Dr. Fred Blattner of Scarab Genomics as they take a detailed look at the challenges faced by pDNA manufacturers and how Lonza’s pDNA Production Platform addresses those challenges.

Technology Transfer of CMC Activities for MAb Manufacturing

As monoclonal antibody products succeed and advance through development, their manufacturing requirements change. The probability of a smooth and successful technology transfer process depends on several factors. Sending and receiving parties must be well aligned in expectations, which can be facilitated by early and detailed planning and communications.

To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory and strategic chemistry, manufacturing and control (CMC) activities necessary to successfully advance new MAbs from discovery to first-in-human clinical trials and the market as quickly and economically as possible. Read this informative white paper to learn more.

Improving IEX Throughput and Performance with Differentiated Chromatography Sorbents

As upstream processing becomes more optimized, it increases the amount of impurity and contaminants to be removed from large volumes of feedstock. With this added pressure on downstream processing, there is a pressing need for more efficient chromatography operations.

In this paper, the authors describe how they characterized differentiated selectivity of Q and S HyperCel ion-exchange sorbents. They evaluated the dynamic binding capacity in various pH, conductivity, and residence time conditions; carried out a separation of a model mixture to further characterize the sorbents’ specific selectivity; and report on a real case application in which one was used in a capture step for purification of a recombinant protein from an E. coli lysate.

Potelligent® CHOK1SV: The Evolution of the GS Gene Expression System™

Lonza and BioWa have combined their technologies to produce a new host cell line, Potelligent® CHOK1SV. This new cell line merges the benefits of Lonza’s GS Gene Expression SystemTM with those of BioWa’s POTELLIGENT® technology. Recombinant cell lines created using this new and improved host cell line have shown:

• Enhanced ADCC
• Growth suitable for a production process
• High product concentration levels in a platform process
• Ability to work seamlessly with current manufacturing processes

Join Allison Porter of Lonza Biologics as she provides a detailed look at the two technologies separately and the performance of the new Potelligent® GS-CHO technology.

Improving Downstream Processing Using Membrane Chromatography

The chromatographer is faced with a variety of anion and cation exchange phases that include a limited range of functional groups. These groups are attached to a wider range of base matrices, such as sorbents for column applications, monoliths and membranes. When ion-exchange membranes are used in chromatography devices, they demonstrate very high usable flow rates with enhanced throughput. Additionally the pre-packed format of these columns enables ease of use and unit-to-unit consistency. It also allows for a disposable chromatographic processes that eliminates costly and time-consuming cleaning validation.

During this on-demand webcast, diverse case studies will be presented that feature applications ranging from contaminant clearance to capture of target molecules in downstream purification processes. These studies highlight scalability, fast and efficient capture of large molecules, and improved process economics. When used in these applications, ion-exchange membranes proved a demonstrable alternative to packed bed chromatography and is better suited for subsequent purification processes..

Join Ajay R. Lajmi of Pall Life Sciences as he takes an in-depth look at the trends and challenges facing downstream processing and illustrates the benefits of membrane chromatography vs. resin chromatography.

Anatomy of a Single-Use Bioreactor Deployment

Rapid commissioning and start-up enabled by system design and process support

Deploying a new GMP single-use bioreactor requires the careful coordination of hardware, software, disposable components, process engineering, tech-transfer and other disciplines. When time pressure is involved as it often is in the current business environment, the task of mastering an unfamiliar piece of process equipment can provide a challenge to biopharm organizations. Recognizing this, Xcellerex has designed the XDR single-use bioreactor as a fully-integrated system that is engineered for rapid delivery and start-up, capable of going from order to delivery to working process in just 12-16 weeks. Further, the Xcellerex team uses XDR reactors every day in our own GMP operations, allowing our technical team to provide fully informed support to customers. This webinar provides an overview of XDR deployment capabilities, and shares a recent customer case history of a successful rapid XDR deployment.

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.