Upstream Processing

Nutrient Supplementation Strategies for Biopharmaceutical Production, Part 2

Some of the numerous feeding strategies are more appropriate than others for certain types of cell culture production systems. Once a nutrient supplement has been identified as described in Part 1 of this three-part review (1), a supplementation strategy must be chosen. Supplementing at too great a rate may expose log-phase cells to stresses such as increased osmolality and lactate levels that would inhibit biomass expansion. But inadequate supplementation can lead to early apoptosis through rapid depletion of selected important…

A Risk-Based Aproach to Establishing Animal-Component–Free Facilities

Bovine spongiform encephalopathy (BSE) and its potential to affect humans emerged as a concern in the 1990s. So suppliers of many essential animal-sourced components used in cell culture and fermentation processes became concerned about the potential for material contamination with prions. Viruses also can be present in raw materials derived from animal origins. Many important drug and vaccine products are made by mammalian cell culture or bacterial fermentation, so their biological safety is paramount. However, it is very difficult to…

Nutrient Supplementation Strategies for Biopharmaceutical Production

Cell-culture–related in vitro recombinant protein production is currently a $70-billion/year business. In 2007, biotech drug sales grew by 12.5%, twice as fast as standard pharmaceuticals (1). Current ongoing efforts to maximize productivity in both time and volume directly affect the scale and capital investment required for a bioreactor suite. As cells reach higher concentrations more quickly while each cell pumps out more product than ever before, the number and scale of bioreactors can be reduced. To that end, not only…

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.

Maintaining Product Titer While Replacing Undefined Components in a CHO Culture System

    Proteins, hydrolysates, and lysates of plant or yeast origin are commonly used in cell culture media for large-scale manufacturing processes for human biotherapeutics. Lot-to-lot variability in the composition of such constituents is well established and can affect multiple biological performance indicators. Our goal was to replace an undefined, protein-containing medium with a chemically defined medium (meaning the chemical structure and concentration for each component in a formulation is known). Such a formulation should be free of protein and…

Rethinking Media Performance

    Fetal bovine serum (FBS) was — and in many cases still is — the supplement of choice to maintain the viability of mammalian cells in culture. However, there are considerable limitations to its use. In the early days of cell culture, the issues surrounding serum were mainly its variable performance and the potential to contaminate cultures with fungi, viruses, and bacteria. Early attempts to produce a serum-free medium (SFM) were academic exercises that usually relied on the use…

Using Innovation to Drive Competitive Advantage

    Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy” segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG ( and Pfizer, Inc. (, for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals ( (1). Several factors…