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…
Facility Design/Engineering
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?…
Disposable Factory or Tailor Made Integration of Single-Use Systems?
The use of disposables in biopharmaceutical manufacturing has increased significantly during the last few years and is expected to grow substantially in the near future. Bioplan Associates report in their 2007 “Report and Survey of Biopharmaceutical Manufacturing Capacity and Production†that the main drivers for this ongoing trend continue to be the elimination of cleaning followed by the reduction of capital investment in facilities and the required equipment. However, with the further penetration of disposables into larger volumes…
Applying Good Engineering Practices to the Design of Single-Use Systems
Significant changes are being incorporated into biopharmaceutical manufacturing processes as a result of drivers such as increasingly strict regulatory demands, reduction of manufacturing costs, and outsourcing to contract manufacturing organizations (CMOs). Historically, many biopharmaceutical processes were designed and built based on cleanable, reusable stainless steel systems and unit operations. Today several industry drivers are shifting some unit operations toward single-use technologies, namely lowered cross-contamination, reduced capital investments, and desired further reduction in manufacturing costs and shortened drug development times (1,2,3).…
Technologies and Training Move Sterility to New Levels
Take six people and sample the microbial ecosystem on their forearms, and you will find more than 240 distinct microbes (1, 2). So it becomes readily apparent why keeping a cleanroom “clean” is a difficult task. One problem is that we humans are limited in our visual capacities and can see objects down to only 50 µm (3). If we could see contaminating particles, we would likely be very quick to clean them away. In fact, cleaning and cleaning validation…
The Genesis of New Production Tools for Biotechnology Manufacturers
The biotechnology industry has from the start been characterized by its dependence on innovation. New therapeutics, new indications, new technologies — and the continual drive toward new approaches for optimizing processes — all contribute to getting novel products to the market (and to patients) efficiently and cost-effectively. Most of the technical literature reports on development processes for the therapeutic products themselves. But one element largely ignored forms an essential foundation to the work of the biotechnology industry: How are products…
It’s Not Whether but Rather What and How to Implement
When considering integration of single-use technologies (SUTs or disposables) into a manufacturing process and facility, a number of criteria should be satisfied. These criteria govern both selection and implementation. Each criterion should be established by due diligence in which end-user requirements and the operation setting are considered carefully. Depending on a facility’s infrastructure and even a company’s business model, end users will define their criteria differently. Companies are driven to single-use technologies because of the simplicity and flexibility they impart…
Cutting Down Process Time and Costs
Because the biopharmaceutical industry operates as an industry rather than a nonprofit, the bottom line is an important consideration in every aspect of product design. From laboratory automation methods that speed discovery to streamlined manufacturing processes that incorporate the themes of operational excellence, Lean manufacturing, and quality by design, the industry is undeniably focused on minimizing cost and maximizing revenue. At the BioProcess International European Conference and Exhibition, the Scale-Up and Manufacturing track will focus on economic strategy and technology…
In the Facility Design Zone
As companies grow and expand their product offerings, it becomes necessary to consider manufacturing space. The decision to build is not made lightly, because CGMP manufacturing space comes at a steep price. Estimates range from $500 to $1,400 per ft2 to build new biopharmaceutical manufacturing space (1,2,3). As Jean-Francois Denault, Agnes Coquet, and Vincent Dodelet point out in their article in the February issue of BioProcess International, non-GMP biomanufacturing space comes at a much lower cost due to the lack…