Manufacturing

Bioterrorism legislation is in the works, but there will be a tough fight to enact added liability protections for manufacturers.

Disposable products and systems have come a long way since they first entered the small-lab market in the 1970s. Today they are available for practically every aspect of biopharmaceutical manufacturing. Disposable systems are used for filtration, clarification, purification, and separation applications used in the production of vaccines, monoclonal antibodies, and other therapies. As the use of disposable systems grows, the concept of a completely disposable manufacturing process is becoming a reality.

In most production environments, it is critical to be able to associate historical environmental data with process data.

Unfortunately, once circuits are commissioned and validated, optimizing - or even adjusting - them is difficult and rarely done because of the time and effort required for revalidation.

Wyeth BioPharma has identified cycle-time reduction as critical to customer responsiveness and the success of commercial and pipeline products. In formulating a plan of attack, the company focused on two aspects of cycle time: the global planning process and disposition cycle times.

Identifying issues in the factory that traditionally arise in the field minimized onsite equipment rework and subsequent qualification work.

The objective of the feasibility stage is to determine whether the proposed biotechnological process can be executed.

It is not likely that you will ever personally design and build a cleanroom; however, you may be responsible for the care and upkeep of many.

Using disposable components for bioprocessing can reduce costs and complexity and may play an increasing role in large-scale biopharmaceutical manufacturing.

This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.

The biotechnology and pharmaceutical industries have some overriding concerns, namely regulatory and compliance issues, insufficient manufacturing capacity, and the economic challenges of producing niche drugs and therapies.

Biopharmaceutical manufacturers face many bioprocessing concerns including safety, flexibility, maintenance, capacity, capital investment, and process costs. Disposable products can reduce some of the burden.

by Demetri Petrides, Alexandros Koulouris, and Charles Siletti, Intelligen, Inc. Bottlenecks are everywhere, from the freeway overpass during the morning commute to the long lines at the supermarket. But bottlenecks in a manufacturing process are bad for business. Computer models can help you eliminate those conditions or situations that retard your progress. Whether the goal is strategic planning, evaluating alternatives, purchasing equipment, appraising a facility, or optimizing production processes, simulation tools can improve your analysis.

by Thomas W. Patapoff and David E. Overcashier Genentech, Inc. The freezing method used during lyophilization can substantially affect the structure of the ice formed, the water-vapor flow during primary drying, and the quality of the final product. Controlling how a solution freezes can shorten lyophilization cycles and produce more stable formations.