In preparing for our October supplement on bioprocess design, BPI’s contributing editor Lorna D. McLeod spoke with Bayer Healthcare’s Harald Dinter (vice president of global biological development) and Jens Vogel (CMC development team leader and head of isolation and purification in global biological development) about the downstream bottleneck. Is it or isn’t it a real problem? Does the answer depend on your point of view? BPI: “Does a company’s downstream capacity place practical constraints on increasing production titers? Is that…
Author Archives: BPI Contributor
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.
The Need for a New Process
Surveying BPI readers’ experiences SANJA GJENERO (WWW.SXC.HU) Better, faster, safer: The current drug-development “paradigm” emerging from the FDA is pushing for innovations that reduce process inefficiency and cost. The plethora of new risk-based methodologies include tools being developed as process-analytical-technology (PAT) tools within the encircling parameters of a process design space. All this parallels (and drives) some predictions that the biotechnology industry has seen the last of its blockbuster models, as predictive genomic tools enable personalized approaches to therapeutic development.…
Putting All the Pieces Together
Most people in the industry are struggling with quality by design and how it relates to the acceleration of process development. Many are confused by the new FDA approach to bioprocess development, unsure of the specific implications of QbD on the CMC section of their marketing applications, and unclear how the risk-based approach applies to their particular operations. Some have trouble understanding the precise link between CQA and CPPs under a life-cycle approach and are stuck considering the exact definitions…
Sailing Through Pharmaceutical Risk Management
The New World In 2002, responding to public outrage over a series of corporate accounting scandals, the US Congress enacted a law now generally referred to as “Sarbanes–Oxley” or SOX (2). Under this law, the US Securities and Exchange Commission (SEC) issued regulations defining new requirements. Promulgated for misdeeds arising in the financial sector and driven by the SEC, most analysts now view this legislation as financially unifunctional. The growing complexity of business organizations, however, and the interdependency of their…
Global Marketplace
Contamination Control Product: Endosafe-PTS glucan assay Applications: Biopharmaceutical process validation Features: The Endosafe-PTS glucan assay is a rapid test designed to help companies validate that products are free of (1,3)-β-D glucans. Glucans contaminate cell culture fluids, yeast protein production, air quality samples, and cellulose filter preparations. Glucans can cause false positive results in LAL assays. The Endosafe-PTS glucan cartridges have a sensitivity range of 10–1,000 pg/mL, yield results in
Promoting Discussion in the Biopharmaceutical Community
The Biopharmaceutical Emerging Best Practices Association (BEBPA) hit the scene in September 2008 with its inaugural Bioassay Conference in Berlin, Germany. A not-for-profit association, BEBPA (www.bebpa.org) is managed by the biopharmaceutical scientific community for the benefit of the biopharmaceutical scientific community: companies, regulators, and clinicians. BEBPA provides an open international forum for the presentation and discussion of scientific issues and problems encountered in the biopharmaceutical community. The purpose of this open discussion is to promote development of innovative approaches and…