What is Quality by Design (QbD) – and Why Should You Care?
Sponsored By: DPT Laboratories
Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone.

Leak Rate Testing for Freeze Dryers
Author: Lisa Hardwick
Sponsored By: Baxter BioPharma Solutions
A study was performed to use a more scientific approach to establish leak rate acceptance criteria, by answering the question: What is the maximum volume of air that can leak into the freeze-dryer without violating the Class 100 / Grade A microbial specifications?

How Can Manufacturing Get More Out of Rheology?
Author: Robert G. McGregor
Sponsored By: Brookfield Engineering Laboratories
Rheology is the science that investigates the flow behavior of materials.  Whether the product is a liquid, cream, paste, or powder, manufacturing transfers raw ingredients through multiple processing stages to create the finished product.

Industry Report on Viral Destruction: Smooth thermal processes consistently and effectively destroy these germs
Author: John Miles
Sponsored By: MicroThermics
This Q&A report includes information on viral inactivation and sterilization; and integration, scale up, and advantages of high temperature short-time (HTST) and ultra-high temperature (UHT) processes.

Aqueous Critical Cleaning: A White Paper
Author: Malcolm McLaughlin
Sponsored By: Alconox
Validation white paper – This comprehensive white paper covers the how to design and execute a cleaning validation in the pharmaceutical industry.  It covers the determination of limits and how to perform aspects of cleaning validation such as sample collection.

How to Control the Nutraceutical Supply Chain
Authors: Jonathan Feinbaum and Anthony Harnack
Sponsored By: Aptean
Myriad regulations pose compliance challenges for drug manufacturers, but if done successfully, business opportunities can arise.

Keeping Relative Humidity Calibrated: To find the right vendor you need to ask the right questions
Author: David Love
Sponsored By: Rotronic Instrument Corp
Many processes in pharmaceutical science require controlled humidity to produce the desired product and preserve the necessary quality control. To maintain a humidity-controlled environment, manufacturers must keep instruments calibrated. Do you really know your relative humidity calibration vendor?

Improving Productivity in Purifying Antroquinonol Using UltraPerformance Convergence Chromatography (UPC2) and Preparative Supercritical Fluid Chromatography (Prep SFC)
Authors: Rui Chen, John McCauley, Jo-Ann Jablonski, Carol Fang, and Jacquelyn Runco
Sponsored By: Waters Corporation
Natural products are a productive source of leads for new drugs due to their high chemical diversity, biochemical specificity, and many "drug-likeness" molecular properties. A large portion of today's existing drugs on the market are either directly derived from naturally occurring compounds or inspired by a natural product.

Quality-by-Design Approach to Stability Indicating Method Development for Linagliptin Drug Product
Authors: Syed Salman Lateef and Vinayak AK
Sponsored By: Agilent Technologies
In this work, method development process is performed using QbD tools, in order to minimize variation in execution and method transfer. Multiple column chemistries are evaluated, with the help of QbD software and the Agilent 1200 Infinity Method Development Solution.

Modernizing the USP Monograph for Acetaminophen
Author: Rongjie Fu
Sponsored By: Agilent Technologies
A USP method for Acetaminophen is transferred to superficially porous Agilent Poroshell 120 columns for significant time and solvent savings.  Several phases of Poroshell 120 are compared.

Transfer the USP method for Ceftizoxime from a Traditional 5-um Column to an Agilent Poroshell 120
Author: Rongjie Fu
Sponsored By: Agilent Technologies
A USP method for ceftizoxime is transferred to a superficially porous Agilent Poroshell 120 column for significant time and solvent savings.

Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin, Feng Zhang, PhD, and James C. DiNunzio, PhD
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.

Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution
Authors: L. Sarode, S. Malekar, C. Cote, and D. R. Worthen
Sponsored By: Nisso America
The purpose: to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot melt mixed ASDs of FLD.

Tableting Performance of Sorbitol Excipient
Author: Marjorie Lejeune
Sponsored By: Tereos Syral
Tereos Syral has conducted a formulation study to assess the tableting performance of sorbitol excipient (spray-dried and crystalline) against lactose when associated with ascorbic acid at 25%. It shows that sorbitol ensures high quality, while providing competitive advantages in terms of hardness, friability, color stability, dilution potential, and dissolution profile.

Robotic teamwork - Complex Assembly with Inspection and Laser Welding
Author: Felix Henning
Sponsored By: OPTIMA pharma GmbH
A form of administering drugs that goes beyond anything known to date, is the associated process in which several components are joined into one another and to some extent welded as well. The medication container, which resembles a carpule, only constitutes a product that is ready for use together with numerous other components.

2014 QMS Health Check
Author: Martin Lush
Sponsored By: NFS International
Time to take a look at your QMS. Time for an overdue Health Check. With increasing numbers of FDA 483 warning letters, consent decrees, and recalls, it's time to evaluate your QMS. Time to take NSF Health Sciences Pharma Biotech's QMS Health Check to ensure your business is ready for 2014.