Overview of Aseptic Fill/Finish Manufacturing

Fri, 24 Jun 2011 15:58:25 GMT

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

Tue, 14 Jun 2011 12:35:31 GMT

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.

News Releases

Wed, 30 Apr 2008 05:46:34 GMT

Date	Title

April 29, 2011	Liberty selects BioRealty to develop city's science and technology park

April 26, 2011	MO: City of Liberty Partners with BioRealty to Develop 42-acre Science Technology Park

June 5, 2008	BioRealty Inc. to develop a 100-acre science park in Grafton

June 5, 2008	100 Acre Science Park on Tap for Massachusetts

June 9, 2008	Developer Takes A Chance On Science Park

August 14, 2007	Tech Journal South BioRealty financing plant for Virginia’s CEL-SCI

June 10, 2007	BNet BioRealty Buys Quest Diagnostics Building

Fall 2007	Development Magazine The Systems, The Credit: Biotech Issues You Need To Know

August 2007	Genetic Engineering News Manufacturing Facility for Multikine Cancer Drug

June 12, 2007	Globe Street – Buyer acquires Read more... The Biomedical Industry's Emerging Clusters Mon, 11 Dec 2006 05:27:22 GMT 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.” Read more... The Next Wave of Ethanol Offtake Agreements Mon, 30 Oct 2006 02:52:53 GMT 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. Read more... Biofuels - The Fuels of the Future Sun, 29 Oct 2006 08:16:00 GMT 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. Read more... 6 Common Causes of Development Delays for Biofuel Projects Sun, 29 Oct 2006 07:53:30 GMT 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. Read more... Synthetic Hype Wed, 25 Oct 2006 08:07:11 GMT 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. Read more...

BioRealty News Feed

Overview of Aseptic Fill/Finish Manufacturing

Article Overview

Designing a Flexible Facility for Biopharmaceuticals

News Releases

The Biomedical Industry's Emerging Clusters

The Next Wave of Ethanol Offtake Agreements

Biofuels - The Fuels of the Future

6 Common Causes of Development Delays for Biofuel Projects

Synthetic Hype