Formulation and Drug Delivery

As part of a major project to design and build a new bulk vaccine antigen plant, the authors were asked to investigate and implement a suitable fumigation system for clean room decontamination. The facility was designed to handle and contain live influenza virus, and has clean room suites designed to containment levels CL2 and CL3 according to the Approved Code Of Practice and Guidance (ACOP, Control of Substances Hazardous to Health 4th Edition). From the outset, specific areas within the facility were identified as requiring fumigation and this formed part of the initial design brief.

We are currently experiencing a problem with one of our tablet lines. While the tablets appear white immediately after manufacture, after a time many of the tablets begin to take on a yellowish appearance. Could this be an issue that surface analysis could help resolve?

Actavis Acquires Site From Pfizer, Cardiokine Names President and CEO, More...

Novo Nordisk Drops Inhaled Insulin Product, Neurocrine Appoints CEO and President, More...

Crucell and Sanofi Pasteur Sign Agreement, WuXi Pharma Names COO, More...

The National Nanotechnology Initiative's new strategic plan affirms the federal government's support for research and development in nanotechnology, including for medical and healthcare applications.

Merck Sells Facility to Cherokee Pharmaceuticals, Inflazyme Announces Senior Management Resignations, More...

There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.

The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.

News, world briefs, facility roundup, events and other items for January 2008.

The use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..

Millipore and Novozymes Form Alliance, Applied Biosystems Names President and CEO, More

Merck & Co. initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, Pedvaxhib, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax.

Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

Company and People Notes: Eisai Acquires MGI Pharma, Ceregene Names CEO, More

Researchers at the University of Kentucky (KY, USA) have located a gene that kills cancer cells while leaving normal cells intact.

Company and People Notes: Boehringer Ingelheim Expands Facility, Regulus Therapeutics Names President and CEO, More

Various manufacturing techniques can improve a drug's solubility, thus increasing its bioavailability. The authors examined whether melt granulation can enhance drug solubility using meloxicam as the drug substance and myrj-52 as the binder.

To keep up with applications, FDA promotes new testing and administrative methods.

In honor of Pharmaceutical Technology's 30th anniversary, the editors conducted a survey of 320 readers last spring to discuss industry advances and future directions. Here are some of your foward-looking responses.

Individualized dosing for specific patient needs has been the goal of medical and pharmacotherapy specialists since they first envisioned pharmacogenetic evaluation. With the measurement of individual levels of metabolism, the optimum dose can be calculated for each individual patient.