Authors



Narinder K. Mehta

Latest:

Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Optics

by Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.


Mary A. Thomson

Latest:

Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Optics

by Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.


David Hernandez

Latest:

Development of an In Situ Spectroscopic Method for Cleaning Validation using Mid-IR Fiber-Optics

by Narinder K. Mehta, Javier Goenaga-Polo, Samuel P. Hernandez-Rivera, David Hernandez, Peter J. Melling, and Mary A. Thomson, Remspec Corporation A fiber-optic, mid-IR spectroscopy probe combined with a grazing-angle reflectance sampling head can be used as a solvent-free in situ method for validating cleanliness with substantial improvement in accuracy.


Aimee C. Kincaid

Latest:

Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.


Timothy G. Hughes

Latest:

Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.


Serena Donnelly Webb

Latest:

Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.



Edward P. Miller

Latest:

Outsourcing Outlook: E-Procurement ? Successfully Using and Managing Reverse Auctions

by Jim Miller, and Edward P. Miller, PharmSource Informaton Services, Inc. Today, reverse auctions are perceived more realistically than in years past, but they still offer many benefits for both buyer and seller.


Jonathan N. Webb

Latest:

Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.


Lorna D. McLeod

Latest:

Sumeria to Satellites: Evolution of the Bioreactor

by Lorna D. McLeod, BioPharm International




David F. Sesin

Latest:

Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration

by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.


Mark D. Dibner

Latest:

Finding Funding in Biotechnology: Keeping the Companies Alive

by Mark D. Dibner, BioAbility, LLC, and Michael Howell Biotechnology appears to be "the place to be" for venture capitalists, capturing the largest percentage increase in investment for 2001. The value of biotech companies has risen sharply, and many economists are predicing an end to the IPO drought.


Edward R. Ergenzinger, Jr.

Latest:

Guest Editorial: Supreme Court Rules on Festo

Some good news, some bad news for biotechnology patent holders


Martyn Postle

Latest:

Unlocking the Value of R&D: Managing the Risks

by Duncan Pass, and Martyn Postle, Cambridge Pharma Consultancy How does big pharma look at your biotech company as a potential partner? This often depends on how it looks at its own research and development investments ? and how it presents them to shareholders. This insider's look at biotech-pharma collaboration shows you the other side of the equation.


Joe Zammit-Lucia

Latest:

Negotiating and Structuring Strategic Alliances

by David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy The job of many a biotech CEO is scrambling to find and secure funds to support the company's development projects. For many biopharmaceutical companies in early development stages, collaboration with "big pharma" is a compelling answer to the cashflow problem. But strategic alliances should benefit those on both sides of the negotiating table.


Chris Easley

Latest:

Negotiating and Structuring Strategic Alliances

by David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy The job of many a biotech CEO is scrambling to find and secure funds to support the company's development projects. For many biopharmaceutical companies in early development stages, collaboration with "big pharma" is a compelling answer to the cashflow problem. But strategic alliances should benefit those on both sides of the negotiating table.


Dechert London

Latest:

Negotiating and Structuring Strategic Alliances

by David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy The job of many a biotech CEO is scrambling to find and secure funds to support the company's development projects. For many biopharmaceutical companies in early development stages, collaboration with "big pharma" is a compelling answer to the cashflow problem. But strategic alliances should benefit those on both sides of the negotiating table.


Michael Howell

Latest:

Finding Funding in Biotechnology: Keeping the Companies Alive

by Mark D. Dibner, BioAbility, LLC, and Michael Howell Biotechnology appears to be "the place to be" for venture capitalists, capturing the largest percentage increase in investment for 2001. The value of biotech companies has risen sharply, and many economists are predicing an end to the IPO drought.


Duncan Pass

Latest:

Unlocking the Value of R&D: Managing the Risks

by Duncan Pass, and Martyn Postle, Cambridge Pharma Consultancy How does big pharma look at your biotech company as a potential partner? This often depends on how it looks at its own research and development investments ? and how it presents them to shareholders. This insider's look at biotech-pharma collaboration shows you the other side of the equation.


David Schulman

Latest:

Negotiating and Structuring Strategic Alliances

by David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy The job of many a biotech CEO is scrambling to find and secure funds to support the company's development projects. For many biopharmaceutical companies in early development stages, collaboration with "big pharma" is a compelling answer to the cashflow problem. But strategic alliances should benefit those on both sides of the negotiating table.


Liz Howard

Latest:

Criminal Penalties for Theft of Biological Material

by Liz Howard, Orrick, Herrington & Sutcliff, LLP Trade secret theft and economic espionage laws apply to biopharmaceutical researchers. Learn what your company needs to do to retain protection under the Economic Espionage Act and what employees need to know to pretect themselves from criminal charges.


Edward P. Moser

Latest:

Outsourcing Outlook: E-Procurement - Reverse Auctions and the Seller's Perspective.

by Jim Miller, PharmSource Information Services, Inc. and Edward P. Moser



Linda Magee

Latest:

Viewpoint: United Kingdom highlights biomanufacturing capabilities

by Linda Magee, Bionow The United Kingdom has the second largest biotechnology industry in the world, a leading position in Europe, an excellent science base, proven capability in the development of drug candidates, and a record of several firsts in technology development.


Karl Bayer

Latest:

Optimizing Recombinant Microbial Fermentation Processes: An Integrated Approach

by Karl Bayer, Monika Cserjan-Puschmann, Reingard Grabherr, Gerald Striedner, and Franz Clementschitsch, Institute of Applied Microbiology, Vienna, Austria A new strategy for controlling recombinant gene expression improves efficiency, maximizes host vector exploitation, reduces costs, improves product consistency, and accelerates product development. Continuous feeds of limited amounts of inducer proportional to biomass growth grant optimal control over the ratio between gene expression and host cell metabolism, providing stable, prolonged recombinant protein production.


Eric DeRitis

Latest:

Targeted Biomarketing: Helping Biotech Businesses Grow

by Eric DeRitis, Real PR Network Communicating presents an image of openness, engendering trust; when you don't communicate, people soon think the worst. Biopharmaceutical companies frequently ignore corporate marketing until too late in the game: Public relations should start at inception to help companies start out correctly.


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