May 2010 Editor's Picks: Products from ATMI and SciLog - Pharmaceutical Technology

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May 2010 Editor's Picks: Products from ATMI and SciLog

Equipment and Processing Report

Featured products from Pharmaceutical Technology's monthly newsletter, Equipment & Processing Report

product ATMI
Bioreactor simplifies scale-up and qualification

The PadReactor from ATMI (Danbury, CT) is a scaleable, single-use bioreactor that incorporates a square bag in a square tank. The bioreactor’s PadMixer technology includes a sparger integrated into the mixing element and achieves gas transfer and mixing at low tip speed and low shear. The system’s gentle mixing technique helps to achieve high yields, high cell density, and high productivity per cell. The PadMixer unit is scaleable from 20 to 2000 L, and the PadReactor unit is available in 20–1000-L sizes. The bioreactor’s scaleability helps close the gap between development and manufacturing, according to the company.

In addition, the bioreactor is available with an open-architecture process control that allows personnel to use a turn-key integrated controller or any other preferred controller. The systems also use ATMI’s Integrity TK8 film-polymer vessels. After a manufacturer qualifies the multilayer film for use in a process, it does not need to requalify other Integrity processes or vessels of various sizes.


productSciLog
Purification system maintains constant flow rate

SciLog’s (Middleton, WI) mobile SciFlex 150 tangential-flow filtration system is designed for pilot-scale biopurification applications. The system’s separate, independently controlled feed and diafiltration pumps allow for automated maintenance of constant flow rate or pressure during ultra- or diafiltration. Precalibrated in-line sensors provide real-time process data about pressure, temperature, and conductivity, while a balance measures the retentate and permeate in the system.

The SciFlex device is compatible with disposable tubing sets that eliminate the need for cleaning and reduce the potential for cross-contamination. Disposable tubing sets also allow the unit to accommodate flat-sheet and hollow-fiber filters from any manufacturer.

A touch-screen interface allows operators to control the system, including the diafiltration and feed pumps. The touch screen also provides real-time trending, documentation, and connectivity for data-collection applications. The control unit achieves the target flow rate and maintains diafiltration retentate by controlling set points semiautomatically.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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View Results
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Equipment and Processing Report,
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