Science and Technology

Definition Science and technology companies include firms within a wide range of industry sectors including biotechnology, pharmaceuticals, nanotechnology, bioinformatics, biomedical, medical device, diagnostics, biopharmaceutical processing, and data management and storage among others.

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Articles

Overview of Aseptic Fill/Finish Manufacturing

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Written by Douglas Stockdale President, Stockdale Associates, Inc.   

Editorial note: This article was written prior to the new FDA Guidance for Aseptic Processing being published. The second part of this article to be published in the near future will reflect the new Guidance recommendations.

Article Overview

Provide an overview of the critical manufacturing process, aseptic fill/finish production of sterile products.

This article is the first of a two part series to provide a broad overview of the aseptic fill/finish manufacturing process. This first article will discuss the background of aseptic products and the operational requirements of the aseptic operation. This will include the personnel, cleanroom, preparations, and the fill/finish process equipment and a brief discussion of the sterile lyophilzation requirements. The second article will discuss the global regulatory and compliance requirements and will include the process validation of an aseptic manufacturing operation.

 

Designing a Flexible Facility for Biopharmaceuticals

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Written by Ashot Petrossian , Nigel Smart, and Robert P. Proietto   

By incorporating flexible design features in initial facility construction, biotechnology companies can move from pilot to production operations and market entry in a timely and cost-effective manner. This article describes a 30,000 ft2 facility designed to accommodate phase 1, 2, and 3 clinical trials.

 

The Biomedical Industry's Emerging Clusters

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Written by Stan Wendzel MBA, CPA, LEED AP   

Because government agencies, educational institutions, and pharmaceutical companies are becoming increasingly aware of the benefits that attracting biomedical companies to their area represents, a geographic shift is occurring that could alter the landscape when it comes to biomedical “clustering.”

 

Synthetic Hype

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Written by Stan Wendzel MBA, CPA, LEED AP   


By now most of us have heard and read numerous articles about synthetic leases. We also know synthetic lease transactions are relatively commonplace for financing corporate build-to-suits and acquisitions, and that they are widely accepted by corporate real estate executives, financial institutions, and accounting firms. But is the synthetic lease a panacea for the corporate executive faced with a leasing decision? Are they the perfect solution for keeping real estate assets oil the company balance sheet? Are there any drawbacks to a synthetic lease? Before entering into a synthetic lease, the corporate tenant should know the potential shortcomings of a synthetic lease as well as when and when not to use one.

 

The Next Wave of Ethanol Offtake Agreements

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Written by Stan Wendzel MBA, CPA, LEED AP   


A key part of any ethanol project is the agreement that governs the purchase of the ethanol that is produced. These agreements commonly referred to as “offtakes”, “offtake agreements”, or “marketing agreements” can significantly influence a plant’s profitability. Typically, these agreements are of a “take or pay” nature requiring the offtaker to purchase all of the ethanol that is produced, and from a pricing perspective, these agreements have historically been based upon the spot market for ethanol at the time of production. While these arrangements do provide a producer comfort that his ethanol output will be sold, producers still face significant price risk.

 

Biofuels - The Fuels of the Future

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Written by Stan Wendzel MBA, CPA, LEED AP   


Fuel is known as a substance used for generating energy. Biofuels are types of fuels created from biomass. Biomass is essentially stored solar energy. Compared to most other fuels, the main feature of biofuels is that energy produced through these sources can be recycled time and again – i.e. renewable. This characteristic of biofuels makes them different from other energy sources commonly used today such as nuclear fuels, coal, and petroleum. Another advantage favoring biofuels is that they are biodegradable and thus do not cause harm to the environment. Given these characteristics, and the oil price increases of the recent past, it’s no wonder why there is so much talk today about biofuels.

 

6 Common Causes of Development Delays for Biofuel Projects

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Written by Stan Wendzel MBA, CPA, LEED AP   



As of this writing (October 2006) producing biofuels is a highly profitable business. For example, in the U.S. profits from a typical dry mill ethanol production plant can exceed $1 per gallon based on the current prices of ethanol, corn, natural gas, and distillers dried grains with solubles. When you consider this figure for a typical sized 100 million gallon per year plant you realize each day of development delay equates to approximately $250,000 of lost profits.

 


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