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Green Plants as Biofactories for Drugs
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| By
Juliet A. Zavon
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James E. Flinn
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Green plants and
production systems that are most removed from conventional
commercial food and feed crops are most likely
to succeed
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Optimization, scale-up, and validation issues in Filtration of Biopharmaceuticals, Part 1
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| By
Anurag S. Rathore, PhD
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Alice Wang
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Manoj Menon
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Jerold Martin
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Jennifer Campbell
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Elizabeth Goodrich
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Frank Riske
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Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include:
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Regulatory Beat: FDA Proposes New Systems and Procedures for E-filing Labeling and Other Data
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| By
Jill Wechsler
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One main component of an e-prescribing system is access to accurate, up-to-date information on prescription drugs and biologics based on FDA-approved labeling.
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StreetTalk: PMPs: Easy as 1-2-3?
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| By
Brian O'Connell
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Like any other financial venture, investing in PMPs requires both the patience
of a saint and the ability to absorb some bad news and still hang in there.
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Applications: A Total Water Purification System
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| By
Jeffrey Denoncourt
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Although sounding like a singular term, a water purification system actually consists of several key components.
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Outsourcing Report: Contract Players
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| By
Jim Miller
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Technology innovations aimed at increasing yields and shortening development times can be very cost-effective, promising to reduce the need for large capital investments while getting the client into the clinic much faster.
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Final Word: Plant-Made Pharmaceuticals
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Sabrina Wagner
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There is no current capacity crunch due to increased investments in new facilities.
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Editorial—Welcome to Our PMP Series
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Carol L. Fisher
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What were you doing on the evening of July 20, 1969? If you are at least a baby boomer, you were probably watching Neil Armstrong take "one small step for man, one giant leap for mankind." Sputnik aside, the birth of that monumental achievement probably began with the same question that sparked so many other great feats: "What if?" Where would civilization be if someone periodically hadn't had the imagination and the courage to ask that question, whether their field of expertise was aeronautical engineering, architecture, or biotechnology?
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