Articles on disposables: implementation, validation, cost-benefit analysis - BioPharm International

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Disposables
The advantages and disadvantages of disposables, along with cost-benefit analyses, validation strategies, and implementation approaches.

Disposable Bioreactors: The Next Generation

April 1, 2008

Disposable technologies that mimic the conventional stainless-steel bioreactor will be most readily adopted

Extractables and Leachables Study Approach for Disposable Materials Used in Bioprocessing

February 1, 2008

Two case studies illustrate a systematic approach.

Disposable Process for cGMP Manufacture of Plasmid DNA

November 2, 2007

Disposables are increasingly being used in the manufacture of biopharmaceuticals. This article describes the design of a fully disposable process for the cGMP manufacture of clinical trial grade plasmid DNA. It addresses the rationale for implementing such a process with respect to the manufacture of patient-specific plasmid DNA vaccines for the treatment of leukemia. The process incorporates a number of disposable technologies, which are simple to use and thus reduce the need for investment in expensive equipment and cleaning validation.

Design and Testing of a Prototype Large-Scale Bag Freeze–Thaw System

November 2, 2007

A solution for the problems of a "bag in a can" system would be a fully jacketed and insulated container, similar to a traditional freeze tank.

Single-Use Technologies—A Contract Biomanufacturer's Perspective

November 2, 2007

One of the challenges of adopting single-use technology is that not all cell lines are compatible with disposable bioreactors.

Antibody Purification with an Integrated Disposable Assembly

November 2, 2007

Comparison of the integrated assembly purified MGG to the control revealed that the purity if the MGG was very high.

A Next Step in Implementing Disposables: Transfer Lines

November 2, 2007

Single-use systems reduce maintenance and capital expense by eliminating expensive vessels, valves, and sanitary piping assemblies.

Manufacturing Vaccines in Adherent Cell Lines Using Disposable Multi-tray Bioreactors

August 2, 2007

The recent growth in the vaccine market has led to renewed interest in using adherent human cell lines for vaccine production. Traditionally, small-scale adherent cell line production has been carried out in roller bottles or T-flasks. Over the past few years, however, a number of companies have found multi-tray disposable bioreactors an effective method for producing high-quality drug products using adherent cells. These disposable, expandable systems have also facilitated scale up from laboratory to clinical-scale.

Cell-Culture–Based Manufacturing: Meeting the Challenge of 21st Century Influenza

August 2, 2007

Vaccines against strains originating from avian flu may achieve poor yields in egg-based systems. Consequently, both public and private interest in alternative systems is high.

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