2011

Japan

Japan is the third largest economy in the world. Its chemical (and classical drug) industry is fully mature, and it is a founding member and major participant in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) project. The country’s aging population represents an attractive market to outside drug companies. Some well-known vendors to the bioprocess industry are headquartered in Japan, including Tosoh Bioscience and Shimadzu Scientific Instruments. “Japanese companies have become so…

Fill and Finish for Biologics

    As most novelists will tell you, if you make substantial changes to the beginning of a story, you may well need to revise your preestablished conclusion. Similarly, as approaches to process design and development change, new tools, technologies, and various shifting “paradigms” also affect the way companies approach final formulation, filling, and finish steps. As yet another ref lection of increased process understanding and quality-by-design’s (QbD’s) holistic approach to biopharmaceutical development, those final steps — traditionally outsourced by…

Singapore

Begin a discussion about Singapore, and most likely the word hub enters the conversation. This small country is giving a full-force effort into earning a reputation for being the technical, financial services, and industrial center of the Asia–Pacific region. Its gross domestic product (GDP) per capita (~$57,200 in 2010) is comparable with most Western developed countries. Like South Korea, India, and China, Singapore aims to grow its market share in the biosimilars sector. The difference, however, says Pete Gagnon (CSO…

A Framework for Selecting and Working with a Normal-Flow Filtration Supplier

The biopharmaceutical market accounts for about 20% of the total market for pharmaceuticals, but its share continues to increase because of double-digit compound annual growth rates leading to projections that by 2014 eight of the top 10 best-selling drugs will be biologics (1). The industry faces many challenges and opportunities, as Jim Davies of Lonza Biologics explained to me: “Biomanufacturers have to contend with what is at present a dynamic technical and commercial landscape. Industry consolidation continues to occur as…

Are Single-Use Technologies Changing the Game?

Recently, I have heard the term game changer used to describe single-use technologies (SUTs). Whether this is hyperbole or reality remains to be seen. But it does bring baseball to my mind. After all, it’s finally spring, games began in April, and optimism reigns supreme — at least in some major-league cities. I was struck recently by an article in my home-town Washington Post by venerated columnist Thomas Boswell, who wrote in March about hope for the future of our…

NIR Spectroscopy Analysis of Phosphate Salts

Confirmation of raw material quality is a vital part of biopharmaceutical manufacturing processing. Incorrect or poor-quality vendor materials account for a considerable portion of failed and recalled product. To prevent these expensive problems, strict quality control (QC) procedures are often implemented and used to screen for inappropriate incoming materials. QC procedures commonly used are chemical tests that involve removing samples to a laboratory and performing, which can at times be complex, time-consuming, and laborious protocols. A common test procedure that…

Productivity Bottlenecks Drive the Demand for Innovation

    Spending is up, the global economy is slowly getting back on track, and the biopharmaceutical industry continues to roll along at double-digit growth. Productivity has been the primary industry focus over the past few years, and it remains a hot topic. Companies are aggressively going after the bottlenecks to their efficiency, and now they’re opening their wallets to fix what’s broken. One of the biggest productivity fixes today centers on improved single-use devices and systems. They top a…

Working with a Powerful and Robust Mixed-Mode Resin for Protein Purification

    Orthogonal methods for assuring robust downstream purification are critical to today’s demanding downstream process industry. Regulatory scrutiny on the immunogenic propensity of drugs has increased and broadened over the past two decades. Although immunogenicity can come from a number of sources, common concerns include host-cell proteins and aggregates. Constantly lurking in the background are other issues such as viral clearance, DNA levels, and so on. Those problems can be addressed simultaneously with the mixed-mode chromatographic support known as…

Global Marketplace

Shaker–Incubator Product: Multitron II system with shaker-bag option Applications: Cultivation of mammalian, insect, or plant cells Features: A Multitron II unit (50-mm orbit) with shaker-bag option enables 1- to 10-L cell cultures in disposable bags. Direct gassing of air or air–CO2 mix provides pH stability, and media temperature is controlled by air inside the incubator chamber. Up to three 2-L or two 10-L bags, or one 20-L bag from a number of manufacturers can be accommodated. The system also works…

Disposable Bioreactor Sensors Play Catch-Up

The evolution of single-use bioreactor (SUB) systems in biologics manufacturing has been rapid and influential. Reliance on efficient and flexible bioreactor technology will be critical for reducing scale-up costs and facility capital expenses as well as aggressively growing biotherapeutic and monoclonal antibody production. The biopharmaceutical industry has seen considerable growth in the proliferation of single-use bioreactor platforms as well as manufacturing areas where these systems are applied. Need for Improved Single-Use Sensors As disposable technologies are widely accepted and established,…