BPI White Papers

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.