Equipment

Strategies to minimise particle levels in the finished product when using single-use technologies downstream of final filters.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

The authors compare three systems of single-screw extrusion using binary formulations for their suitability for producing pellets of various formulations and under various spheronization conditions.

Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.

Results from our annual survey. This article contains online bonus material and is part of a special issue on Bioprocessing and Sterile Manufacturing.

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

Over the past 10 years or so, we've seen single-use technologies explode from production-scale filter capsules, tubing and simple biocontainers to encompass sterile connectors, membrane chromatography adsorbers, bioreactors, mixers, and integrated platform systems with increasing levels of sensors and automated controls.

The willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Drugmakers have many incentives to avoid overfilling their containers, including the scarcity, and correspondingly high cost, of certain cells and ingredients. These concerns highlight the need for techniques that can fill small volumes of product with great accuracy. Many strategies are available to the industry, but which one works best?

Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly.

A look at the true cost-drivers of cell-culture production.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

Any aseptic processing technology that allows intervention by gowned personnel during operation cannot be considered an advanced technology. Although a standardized definition of restricted access barrier systems has been developed, these systems fall well short of being classfied as advanced technologies.

The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.

There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility.

The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.

A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.

The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.

A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

Measurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.