Manufacturing Contract Services

Implementing Disposable Sampling Devices for Fully Autoclaved Equipment

Sampling is used extensively to monitor both behavior and quality throughout biopharmaceutical processesing (1, 2). Methods must deliver representative samples and — more important — not compromise the integrity of a given unit operation or the process of which it is part. When microorganisms, animal cells, viruses, or nonfilterable materials are involved, sampling methods must not introduce contamination (see the “Regulatory Requirements” box). For successful sampling, three methods have been used routinely over the years: steam-in-place (SIP) valves; aseptic tube…

Supporting Continuous Processing with Advanced Single-Use Technologies

It has been 10 years since the US Food and Drug Administration (FDA) articulated — in its guidance for process analytical technology (PAT) — the goal of “facilitating continuous processing to improve efficiency and manage variability” (1). Since that time, regulators and industry have worked toward applying continuous processing (CP) to all facets of pharmaceutical manufacturing, including bioproduction (2, 3). Last year, the European Medicines Agency (EMA) referred to CP in its draft Guideline on Process Validation, and the FDA…

Sponsors Look to Asia for Potential Contract Partners

As the biopharmaceutical market continues its global expansion, biomanufacturers are becoming increasingly comfortable with the idea of outsourcing activities to international destinations. This year, China expanded its lead as the primary potential destination. This measure of interest shows how the country’s international outsourcing potential and global perception have changed over the past five years. It also suggests a greater international awareness of opportunities opening up in China for local production. Figure 1: () More than a quarter (26.2%) of the…

Lean Six Sigma

    About 10 years ago as a vice president of Avecia Biologics, I wrote an article for an early issue of BioProcess International looking ahead at likely changes in biomanufacturing (1,2,3). For the best part of the intervening period, Avecia Biologics and Diosynth slugged it out in the marketplace, each trying to grow its contract manufacturing business at the expense of the other. But in a life-altering two-year period between 2009 and 2011, both companies saw their realities and…

A Decade of Outsourcing

    Outsourcing has been such an integral part of the bioprocessing industry that BPI made it the focus of its first supplement (September 2003). Since then, manufacturers continue to reach beyond local and national borders to extend their networks of partnerships to emerging markets. Global economics during the past decade have not always made outsourcing easy. Ten years ago, manufacturers faced tough decisions over whether it was more cost effective to outsource or keep process activities in-house (possibly expand…

Mastering Industrialization of Cell Therapy Products

    Incomes currently generated by the global cell therapy market are estimated to be ~US$400 million. That value represents 10 main products, some of which have been on the market since the late 1990s (e.g., Dermagraft and Apligraf, with >$100 million yearly revenues each). Cell therapy product revenues are low compared with those of the biopharmaceutical market (~$100 billion). But the market’s growth potential and clinical pipeline are leading to higher expectations. The sector’s compound annual growth rate (CAGR),…

What’s in a Game?

Not long ago, I was playing the popular board game Snakes and Ladders (also known as Chutes and Ladders) with my son. Based on an ancient Indian board game, it has over the years become a worldwide classic. The game is rather simple to play: Two or more players place their tokens on a game board that has numbered, gridded squares. They take turns rolling a single die to move their tokens by the number indicated by the die, following…

Effect of China’s Talent Scheme on Life-Science Innovation

The impact that the migration of talent is having on life sciences companies’ ability to innovate and differentiate themselves worldwide is a topic of constant concern. Of particular interest are the increasing flows between the United States and China. China’s “1,000 Talents Scheme” and similar initiatives at the local level were specifically designed to help the country become a world leader in innovation. Such programs incentivize people who are among the top 10 practitioners in their field to return to…

China Ranked Top Potential Biopharma Outsourcing Destination

Until recently, China had not been considered a global contender for outsourced biopharmaceutical manufacturing. In fact, it’s been less than a decade since pharmaceutical contract manufacturing in China became legal (1). Yet, the industry now ranks China as the most likely biomanufacturing outsourcing location. According to our recently released study, 17% of the industry considers China as the top future offshore production destination (Figure 1). The BioPlan 2011 Eighth Annual Report and Survey of Biomanufacturing Capacity and Production shows China…

Questions to Consider When Thinking About Companion Tests

Personalized medicine is a catch phrase of the 21st century — and with good reason. Advances in genetics and biochemistry promise to tease apart factors that explain why some patients benefit dramatically from a therapy whereas others receive no benefit at all. They also help explain side-effect profiles. To accomplish such lofty goals, drug makers are increasingly partnering with diagnostics companies to develop companion biomarkers. But these companies operate in very different business and regulatory environments, so partnerships can be…