Facility Design/Engineering

Minimizing the Environmental Footprint of Bioprocesses

    Part 1 of this two-part article introduced the need to reduce the environmental footprint of bioprocesses and evaluated the impact of solid-waste disposal. Part 2 continues by describing the effects of the remaining elements of the bioprocess footprint: wastewater, electricity, and air emissions.   Wastewater   Process Waste Streams: Generally, raw materials to produce and purify biopharmaceuticals fall into one of the following categories: inorganic/organic salts, sugars/polyols, trace elements, vitamins, amino acids, surface active agents, or complex (undefined)…

Containment of High-Potency Products in a GMP Environment

Many modern medicines are highly potent, with only tiny doses required to achieve a therapeutic effect. But a nanomolar medicine poses extra hazards during manufacturing, whether the product is a biologic or a small molecule. These issues have to be evaluated and addressed in the design of a manufacturing facility for such products. Not only is it vital that the product not become contaminated, but employees and the general public must be protected from the product. Exposure to just a…

Challenges in Developing an Infrastructure Strategy

    The idea of “thinking globally, but manufacturing locally” to each market is relatively new to the biopharmaceutical industry. As I mentioned in Chapter 2, vaccine makers are more familiar with the concept already. But many technological and economic factors are making other companies aware of this option. Offshoring clinical trials has been of great interest in the pharmaceutical industry for years now. Is it more cost-effective to make clinical materials “here” and ship them “there”— or to make…

Manufacture Locally, Market Globally?

    One response to a survey we sent out last year kept coming back to me as we prepared this issue. In answer to what a company does if a product in development doesn’t fit into the company’s platform technology, one answer was, “We innovate a solution.” Whether meant seriously or not, it rings true to the history of the industry’s ability to invent and reinvent solutions as necessitated by economic realities. When we began working on the topic…

How Geography Affects the Cost of Biomanufacturing

    As the biopharmaceutical industry undergoes restructuring, its focus shifts to the efficiency of drug development and overall costs of delivering affordable medicines. A question often raised concerns the manufacture of drug substances overseas to tap into a cheaper manufacturing base (1). There are many issues to consider when looking at overseas locations, such as intellectual property (IP), the availability of skilled labor, and the emergence of new markets. The situation is more complex with biopharmaceuticals because the products…

Minimizing Costs and Process Times with Local Biomanufacturing

For a growing number of biopharmaceutical companies, the world is getting smaller. They are operating in smaller, more flexible facilities; servicing potentially smaller markets; and managing local products. Local manufacturers are looking for ways of doing standard processing less expensively without making changes that carry regulatory risk. Most of these facilities are vaccine manufacturing sites. The upsurge in localized diseases and need for global pandemic preparedness (especially under uncertain capacities) have countries such as Malaysia, India, China, and Brazil pushing…

Flexible Manufacturing

Flexibility has quickly become one of the most noticeable buzzwords of the bioprocessing industry. Understanding what constitutes a “flexible” process ranges from the simple application of one specific type of technology (e.g., single-use systems, automation, standard controls) to a somewhat extreme concept of a “throw-away” process. But whatever the definition, the factors leading to the need for more flexible approaches to biomanufacture are clear: Rapid, sometimes unexpected, changes in a company’s business situation and/or product portfolio (whether for patients or…

The Collaborative Future: A Case Study

    In our February 2010 special report, “The Time Has Come for Automation in Bioprocessing,” one theme that made itself clear was the need for vendors, biopharmaceutical companies, and sometimes even regulators to work together toward the goal of better, faster, and cheaper product development through (among other things) automation technologies. Martin Rhiel of Novaris cell and process R&D told us, “It would be really nice to just buy it and implement it, but this doesn’t always work…Nowadays, the…

The Time Has Come for Automation in Bioprocessing

    As early as 1997, automation was ready to offer potential benefits to the bioprocess industry (1). Professor Bernhard Sonnleitner of the Zürich University of Applied Sciences’ Institute for Chemistry and Biological Chemistry suggested a “standard operating procedure” and pointed to the opportunities, requirements, and potential pitfalls of applying the principles of automation to bioprocess development and operations. If “boring and less interesting routine tasks” could “more efficiently and reliably be handed down to machines,” he explained, then personnel…

Integration Is the Future of Single-Use Technology

Single-use technologies are becoming more widely accepted by biopharmaceutical manufacturers than ever before. The market is complex, fast-growing, and dynamic, which means integrated innovative technologies are the key to keeping pace with biopharmaceutical manufacturing needs. In fact, end users are already beginning to move away from singular disposable components to increasingly require suppliers to provide integrated solutions for specific process needs. So it is critical for suppliers to work closely with their customers and provide novel solutions. Why the Switch?…