Featured Whitepaper: Vaisala
A GMP Warehouse Mapping Guide
Sponsored By: Vaisala (Warehouse)
This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries.
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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Sponsored By: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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Finding the right contract manufacturer
Sponsored By: Vetter Pharma International GmbH
Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvest. The pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy.
However, with fewer blockbuster drugs in the pipeline, companies are on the lookout for an enduring solution to meet market challenges. These include rising process costs resulting from stricter quality control criteria, evolving technologies, which are becoming more complex and costly, and the increasing stringency of regulatory standards. To maintain or expand market shares, pharmaceutical companies must devise new strategies to remain competitive. |
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Elemental Impurities: Navigating the Proposed Regulations of USP <232> and <233>
Author: David Kesselring, Ph.D.
Sponsored By: EAG Life Sciences.
The implementation of the proposed chapters USP chapters on elemental impurities, <232> and <233> is best suited to the use of closed vessel digestion and analysis by an ICP analytical technique. This paper addresses the challenges involved, as well as appropriate methods, procedures, and limits associated with this analysis. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Author: Charlie Martin; Feng Zhang, Ph.D.; James C. DiNunzio, Ph.D.
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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CRITICAL CLEANING APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Author: Jeff Phillips
Sponsored By: Alconox
Discussion on the benefits of employing aqueous cleaning in pharmaceutical manufacturing. The proper use of aqueous cleaning helps manufacturers minimize surface residue and makes cleaning validation easier. |
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Interest Grows in Single-Use Pumps
Author: Wallace Wittkoff
Sponsored By: Pump Solutions Group.
One of the key differences between the pharmaceutical and biopharmaceutical industries: the pharmaceutical industry relies largely on synthetic chemical processes while biopharma relies largely on cellular processes. That difference has led to the development of new lines of processing equipment optimized for biologic processes. The latest development is single-use pumps. Wallace Wittkoff, Hygienic Market Director for Pump Solutions Group (PSG®), discusses the need for single-use technology. |
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Asset Accuracy: A professional appraisal is essential to know what you have and what it's worth
Author: Pharmaceutical Technology and Christopher Kinzie
Sponsored By: EquipNet
Pharmaceutical Technology interviews EquipNet’s Director of Appraisals and Valuations, Christopher Kinzie, about how companies can benefit from professional equipment and business appraisal and valuation services. When you know what you have and what it’s worth, you limit risk of liability and maximize the value of your assets. |
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An Overview of the Principles of MSE
Sponsored By: Waters
Waters MSE is a simple, generic method that enables you to obtain “all of the data all the time” in a single analysis. Learn about the key requirements of a comprehensive quantitative and qualitative analytical workflow and gain an understanding of the three stages of MSE. |
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TOC Measurement of Samples Per USP <643>
Sponsored By: Shimadzu
The United States Pharmacopoeia has established guidelines for determining system suitability and established the acceptance of Water For Injection (WFI) purposes and Purified Water (PW) (USP Method <643>). This paper examines the use of Shimadzu’s TOC for meeting these requirements. |
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ACQUITY UPLC H-Class Bio with 2D Technology
Authors: Waters
Sponsored By: Waters
We present Raman spectroscopy as a quick and lower cost alternative to verifying the existence of low concentration methanol in alcohol. |
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Biosimilars: Global Impact of the Biologics Price Competition and Innovation Act of 2009
Author: Beckloff Associates, Inc
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Services Act (PHS Act) to create an abbreviated approval pathway for biological products that are shown to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product. Biological products are generally derived from living material (e.g., human, animal, or microorganism), have complex structures and are usually not fully characterized. |
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Preparing for Mandatory eCTD Submissions to FDA
Author: Greg A. Onyszchuk, Ph.D.
Sponsored By: Beckloff Associates, Inc.
How can PDUFA V possibly be related to the eCTD format for submissions to FDA? Actually, the logic is very straightforward. It is all related to the original PDUFA goal of speeding the review of new products. Among all of the ideas, proposals, commitments, and initiatives debated during the PDUFA reauthorization processes, no area has received as much attention as the FDA performance for the review of new products. |
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Risk Evaluation and Mitigation Strategies (REMS) Under FDAAA
Author: Beckloff Associates, Inc.
Sponsored By: Beckloff Associates, Inc.
The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA's ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. A report commissioned by FDA in the wake of the Vioxx® withdrawal, and subsequently issued by the Institute of Medicine in 2006, concluded that the science of drug safety needed major improvements. |
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The Regulatory Paradox of Laboratory Developed Tests
Author: Richard Angelo, Ph.D.,
Sponsored By: Beckloff Associates, Inc.
The development of increasingly more complex and sophisticated in vitro diagnostic (IVD) devices by clinical laboratories has precipitated FDA concern regarding a lack of product controls. These tests are often produced using available marketed kits, may include components purchased from a commercial supplier, and are offered for use as a diagnostic service. FDA contends that test ingredients or components used in the production of LDTs are essentially unregulated, therefore, of unpredictable quality. The regulatory boundary between FDA-regulated medical devices and LDTs exempt from FDA jurisdiction remains somewhat blurred; however, the looming finalization of the CPG and IDVMIA guidance documents stand to better clarify this borderline. |
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Countering Drug Counterfeiting
Author: Aqeel Fatmi, Ph.D.,
Sponsored By: Banner Pharmacaps Inc.
In addition to regulatory and legal efforts to stem the threat of the growing and serious problem of drug counterfeiting, U.S. drug sponsors are playing an increasing role by incorporating advanced counterfeit-resistant technologies on the dosage form itself, as well as on the packaging. While no single approach is sufficient to solve the daunting problem of counterfeiting across the globe, certain oral-solid-dosage coating technologies that are extremely difficult to duplicate are playing an important role in the ongoing struggle to protect prescription and over-the-counter drug products from counterfeiting and adulteration. Banner Pharmacaps SofletÒ Gelcaps, one of the leading technologies to identify counterfeiting, enrobes the tablet core using customized, proprietary equipment, with a tightly adhering gelatin, protecting active ingredients and providing a strong tamper-evident and tamper-resistant barrier. |
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Developing Palatable Drug Products – Top 10 Myths of Taste Masking
Author: Jeff Worthington, David Tisi.
Sponsored By: Ropack Inc.
Blister, an increasingly dominant force in pharmaceutical packaging, is earning notable interest from pharmas and consumer healthcare companies looking to expand market share. Four reasons for the interest in blister. |
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Barrier technologies – criteria for choices
Author: Jurgen Rothbauer, Jurgen Schafer
Sponsored By: Optima Group Pharma GmbH.
For implementing manufacturing, filling and closing processes, barrier technologies currently are the most commonly used technologies for regulated markets such as Europe, the United States, and Japan. Whether existing cleanrooms are operated with new or upgraded filling and packaging technology or if the enterprise makes investments in completely new manufacturing processes, including sterile and barrier technologies, a universe of options is available to pharmaceutical manufacturers. |
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4 Reasons to Consider Blister Packaging
Author: Paul Dupont.
Sponsored By: Ropack Inc.
Blister, an increasingly dominant force in pharmaceutical packaging, is earning notable interest from pharmas and consumer healthcare companies looking to expand market share. Four reasons for the interest in blister. |
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New HPC grade for DC
Author: Shinichiro Tsue
Sponsored By: Nisso America
We prepared new Super Fine Powder, Special Low Viscosity grade Hydroxypropyl Cellulose with the purpose of developing a high performance dry binder with high compression formability at low use levels. |
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