White Papers / Tech Papers
June 6, 2013
Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to…
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May 20, 2013
Key success factors in fostering and maintaining a long-term strategic partnership
Introduction
2012 will be regarded by many commentators as one of the most challenging years in the pharmaceutical industry’s history, due in no small part to n…
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April 10, 2013
Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff — fe…
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April 4, 2013
by Joe Cobb, R. Justin Brett, Michael D. Ruff, Anthony Berry, Robert Epps
OBJECTIVE
To improve robustness of a core tablet for a novel modified release oral solid dosage form using Quality by Design (QbD) principles.
General Background
As stated in…
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March 25, 2013
Parenteral pharmaceutical products, defined as all innovative and generic products delivered by injection, have several advantages over most other dosage forms:
· Delivery of the drug is fast: 15–30 seconds…
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March 6, 2013
The use of after-market replacement parts for tablet press machinery is not an uncommon practice in today’s economy because many pharmaceutical manufacturers believe that using such replacement parts can be just as effective as using original e…
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February 27, 2013
As regulatory expectations continue to evolve in the area of pharmaceutical development, working with contract research and manufacturing organizations (CRMOs) that couple execution experience with high-end technical capabilities and contemporary qua…
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February 22, 2013
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater acce…
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February 21, 2013
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists. Many considerations influence IV administration including patient safety, medical efficacy, budget implications and labor uti…
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February 21, 2013
Management of medication delivery through lyophilization - freeze-drying - is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins and monoclonal antibodies, must b…
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February 21, 2013
Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since…
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October 25, 2012
The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of enhancing patient care and safety.1 While the goal of p…
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August 23, 2012
by Dr. Weihong Wang, manager of molecular and cell biology, Lancaster Laboratories
Introduction
Characterization of a biological product, which includes the determination of physicochemical properties, biological activity, immunochemical properties…
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July 31, 2012
Kurt Moyer, Ph.D.
Director of Research, NSF Pharmalytica
Bristol, Connecticut, USA 06010
BIOGRAPHICAL NOTE
Dr. Moyer is currently the Director of Research at NSF Pharmalytica. Prior to joining NSF Pharmalytica, Dr. Moyer served as a Senior Resear…
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June 20, 2012
Pharmaceutical companies are moving away from all-inclusive, in-house operations and partnering with Contract Development and Manufacturing Organizations (CDMOs) for solvent-based solid-dose manufacturing. When researching CDMOs, important considerat…
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