Manufacturing

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

A close-up look at Pfizer's biotherapeutics plant in Shanbally, Ireland.

With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.

How to choose a disposable mixing system that fits your particular needs.

Choosing the right tools to enhance the process.

Are disposable bioreactors effective for cell culture?

With virus-based production, vaccines can be available in 10-12 weeks.

The disadvantages of the traditional vaccine regime (prime plus boost) have spurred the development of single-shot vaccines. This article describes the development and manufacture of a prototype single-shot vaccine that uses microspheres made from cross-linked modified dextran polymers for controlled release of the antigen.

This article discusses the potential of MIS416 adjuvant, a vaccine adjuvant and immunogen co-delivery system, to provide adequate immunostimulation to overcome host factors that may limit the success of therapeutic vaccines.

Understanding the relationship between the process and CQAs.

FDA aims to regain public confidence in 2009.

A new method for MAb purification.

How to ensure smooth technology transfers.

The development of a skilled labor force is essential for an expanding biopharmaceutical industry.

To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs.

In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.

No time for QbD? How to convince management to make it a priority.

The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.

Using multivariate experiments to define acceptable ranges.

Results from a process developed for a commercial antibody.

A major problem in personalized medicine has been scale-up.

The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer, Berkeley, CA) for its new sterile filling facility on its Berkeley, CA, campus.

Millipore Corporation (Billerica, MA) and Applikon Biotechnology BV (Schiedam, The Netherlands) have announced an agreement to co-develop and distribute disposable bioreactor systems for biopharmaceutical applications.

Transitioning from stainless steel technology to disposable technology in bioprocessing.

This article describes the steps required to build a comprehensive model in a batch process simulator for a process that uses single-use systems for buffer preparation and storage.

Can disposables reduce your facility's environmental footprint? We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer.

This article describes a quick method for evaluating lifecycle costs for single-use systems against their more conventional stainless-steel counterparts.

Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.