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


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

The Environmental Impact of Disposables

November 1, 2008

Despite creating plastic waste, the disposables option is better for the environment.

Disposable Decisions

October 1, 2008

To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.

Disposables Open Up Possibilities in Facility Design

August 1, 2008

In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.

How to Evaluate the Cost Impact of Using Disposables in Biomanufacturing

June 1, 2008

The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.

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.

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.

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.



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