Featured Whitepaper: Vaisala
A GMP Warehouse Mapping Guide
Sponsored By: Vaisala
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.
|
|
|
| |
 |
|
| |
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. |
| |
Extractables and Leachables for Pharmaceuticals and Medical Devices
Author: Allen Kesselring, Ph.D.
Sponsored By: EAG Life Sciences
Extractables and Leachables (E&L) studies challenge our industry due to their late stage occurrence and investigational nature. This white paper defines Extractables and Leachables and outlines an E&L study plan that is both scientifically relevant and compliant within GXP regulatory systems. |
| |
Analysis of aggregates in nasal spray suspensions
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper reviews the importance of measuring particle size distribution and degree of aggregates in nasal spray formulations. Raman chemical imaging is presented as a greatly improved method of analyzing aggregates and agglomerates in nasal spray suspension formulations. Reviews the time and cost savings compared to current practice. |
| |
Outsourcing in Regulatory Affairs: Insights from the Top Pharmaceuticals
Author: Kristofer J. Spahr, Director of Regulatory Services
Sponsored By: TAKE Solutions
Economic and competitive pressures continue to motivate Regulatory Affairs organizations to explore outsourcing models as a vehicle for providing flexibility and efficiencies across the spectrum of Regulatory business processes. In a recent set of interviews with the heads of Regulatory Operations within five of the top ten global Pharmaceutical companies, this whitepaper reveals how they outsource submissions management activities to some degree and are looking at additional opportunities for further outsourcing expansion. Learn from their shared experiences in submissions management outsourcing and how they have realized positive financial impact in increased productivity, an ability to focus internal staff on higher value activities, and an increased flexibility in meeting submission schedule fluctuations. |
|
| |
|
 |
|
| |
Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: 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. |
| |
CRITICAL CLEANING APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Author: Jeff Phillips, Sr. Manager, Science and Marketing
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. |
| |
Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: KIMBERLY-CLARK PROFESSIONAL* – (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. |
| |
Interest Grows in Single-Use Pumps
Author: Wallace Wittkoff
Sponsored By: Pump Solutions Group (PSG®)
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. |
| |
Improved Productivity in Peptide Purification
Authors: Dr. Reno Nguyen, Scott Anderson, Chitra Sundararajan, Dennis McCreary, Dr. Jochen Saar
Sponsored By: Grace Discovery Sciences
The demand for high purity peptides is increasing. Small synthetic peptides to large cellular produced peptides are being investigated for possible therapeutic benefits. Optimized purification techniques are required to meet these high purity demands in an economical manner. |
| |
Asset Accuracy: A professional appraisal is essential to know what you have and what it's worth
Authors: 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. |
| |
|
| |
|
 |
|
| |
“Countering Drug Counterfeiting”
Author: Aqeel Fatmi, Ph.D., Global Vice President of Research and Development and Operations, Banner Pharmacaps Inc.
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 Soflet® 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. |
|
| |
|
 |
|
| |
Maintaining Aseptic Conditions During Sterility Testing
Author: Jochen Dobberstein
Sponsored By: SGS Life Science Services
USP 35 <71> describes sterility testing as a general requirement, and consistent, meticulous testing is essential to obtain accurate results. This paper describes best practices for sterility testing. |
|
| |
|
|
|
| |
What You Should Know About Lean Six Sigma Initiatives
Author: Jim Webber
Sponsored By: Compliance Insight Inc.
Investment in improvement can take many forms, e.g. capital improvements, equipment upgrades, product redesign, etc. All work is achieved through processes, so if those processes are ineffective and/or inefficient, then less than perfect outputs/cost are the result – and not just once – but over and over again! Resources are scarce, and always will be. Therefore utilization of the resources allocated to process improvement must be done with careful planning and within a well thought-out framework – if you want your organization to have a culture of superior performance. This paper lays out the framework – the foundation for an effective continuous improvement initiative. |
|
| |
|
|
|
|
|
|
|
|
|
|
|
