BPI White Papers

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.

Follow-on Biologics

This webcast will describe the key steps in developing a CHO culture process for manufacturing a follow-on biologic. Analytical characterization of 14 lots of the commercial product provided information about the range in key product quality attributes of the marketed drug. The scientists at SP-Diosynth have developed a process that yields a product that is analytically comparable to the commercially available molecule. Product quality attributes investigated were aggregation, acidic and basic variants, galactose, sialic acid and fucose content, and complement dependent cytotoxicity activity.

Scalability of the process was demonstrated in 100L stainless steel bioreactors and a 50L single use bioreactor (SUB). The webcast shows SP-Dionsyth’s data indicated that the process generates high titer at scale consistently while achieving product quality similar to the commercial material.

With this on-demand webcast, you will gain valuable insight into aspects of SP-Disoyth’s process development, such as:

• Cell Line Characteristics
• Scalability
• Manufacturability
• Comparability
• Commercializability

The webcast features Sigma S. Mostafa, Ph.D.

Microbial Expression Technology: The New Standard For Protein Expression – Addressing Speed, Quality and Cost of Goods

A new paradigm of microbial strain development has been achieved that overcomes today’s slow, iterative and error-prone process through the use of a novel, streamlined, high throughput platform. The P. fluorescens expression platform, Pfēnex Expression Technology™, reliably delivers host strains expressing large amounts of high quality target protein within very short development times. In this webcast, Dr. Charles H. Squires, Head of Discovery R&D at Pfēnex Inc., discusses:

• An Overview of Pfēnex Expression Technology™
• How Pfēnex Inc. Practices the Technology
• Case Studies Highlighting the Power of the Technology
• Product Areas
• Further Uses of Pfēnex Expression Technology™in Development

Join Dr. Squires as he illustrates how the combination of technologies available through the Pfēnex Expression Technology™system make it the most complete, flexible and productive bacterial strain development and biopharmaceutical production platform available today.

Implementing Cost Reduction Strategies for HuMab Manufacturing Processes

To keep up with increasing clinical demand, antibody manufacturers are forced to adapt their methods to increase production without increasing costs. In this informative paper, Dr. Arunakumari Alahari, Senior Director of Process Development at Medarex, Inc., discusses several processes that can be implemented to reduce costs of manufacturing, including:

• Perfusion Process for Cell Line Amplification
• Perfusion Process for Cell Bank Preparation
• CHO Production Using In-House Medium
• High Capacity Non-Protein A Purification Processes

Read the full article to discover how innovative technologies and effective regulatory strategies can accelerate process development and reduce time-to-market.

Many Considerations in Selecting Bioproduction Culture Media

Until recently, the ability to support efficient large-scale culture of cells was the main factor in choice and development of production media. But lately the industry has seen a number of new performance demands imposed on production media, such as:

• Support higher growth rates and culture densities
• Promote culture longevity and suppress apoptosis
• Support clone stability in continued passage
• Promote high product yield
• And many more.

Not only is the overall number of criteria growing, but in fact there are users who must consider many different features in specifying their production media. Read this informative paper to learn more about the many functions now desired from production media.

Monitoring ATP Status in the Metabolism of Production Cell Lines

Because the development of industrial cell culture processes for production of recombinant proteins seeks high efficiency, reproducibility and predictability, it is important to have access accurate analytical tools. Although established analytical methods deliver useful data, they are incomplete because they only partially address the cellular metabolic state and also because no predictions can be made.

This paper discusses the process used to establish and evaluate an assay for rapid and reliable online measurement of intracellular ATP (adenoside-5′-triphosphate) to monitor the physiological state of cells in combination with other parameters (cell number, viability, and glucose consumption).

Considering Cell Culture Automation in Upstream Bioprocess Development

With the increasing importance of biologics in today’s pharmaceutical market, throughput and efficiency are crucial in developing a production cell line. Cell culture automation can be a good solution for high-throughput and labor-intensive areas of a development process. Because of the cost of the investment, there are many factors to be considered before committing to a purchase.

In this paper, Tim Gryseels, a senior scientist at Pfizer, discusses the important steps in identifying and purchasing cell culture automation, and how the automation process can reduce costs and increase throughput, efficiency and consistency.

Mycoplasma In-Process and Lot Release Testing: To PCR or Not to PCR

Mycoplasma are the simplest self-replicating prokaryotes, and they are frequent contaminants of cell cultures. Mycoplasma infection can affect nearly every cell culture parameter and result in decreased quantity or quality of product, inconsistency of manufacture, or possible adverse effects in recipients. Because of this, detection of mycoplasma is extremely important; but because of their small size, limited turbidity produced in culture, the wide diversity of mycoplasma species, and other factors, detection of mycoplasma can be challenging.

Some common culture methods of mycoplasma detection for cell bank and raw material release, in-process, and lot release testing have a long turnaround time (minimum 28 days). For most biological products, the mycoplasma culture test is the rate-limiting step for lot release. This white paper examines alternate methods of mycoplasma detection with shorter turnaround times, such as polymerase-chain-reaction (PCR)—based assays.