Guest blog by Tim Lozier.

My daughter has been learning how to ride a bike for the past year.  She’s actually become quite adept at it, and for someone who loves to cycle, I am certainly proud.  But there were certain obstacles to overcome to get to this point.  We started simply with the tricycle – learning to pedal.  Then we switched to a “run-bike” to help learn balance.  Now we are on a two-wheeled bike with training wheels, and slowly beginning to take the training wheels off.  With each step forward, my daughter expressed a certain degree of fear – “will I be able to do this?,” she intimated. Once she made the leap to the next level, she realized how much easier biking can become.  Leaving the training wheels can be scary, but the freedom of two wheels is much better.

When I speak to customers and prospects about Quality Management Systems Validation, I get much of the same trepidation.  For many years, the concerns of software systems center around the validation of those systems.  After all, if the system fails to work properly, the company becomes liable and any repercussions will most likely not be pretty. Read more »

Emerging markets continue to attract the attention of pharmaceutical companies thanks to their high growth and large patient populations. Back in 2011, the locations of focus were the so-called ‘BRIC’ countries (Brazil, Russia, India and China). But with more markets emerging and drawing the eyes of the pharmaceutical industry have the original BRIC countries lost some of pharma’s favour?

Not at all, judging by several developments this year. Read more »

What will be the future of pharmaceutical outsourcing? What factors will influence the relationships between sponsor companies and contract service providers and what practical solutions are both seeking? These questions were addressed at a conference this week in Philadelphia, Bio/Pharmaceutical Manufacturing Partnerships, organized by CBI in conjunction with Pharmaceutical Technology. Read more »

Continuous manufacturing is the way of the future for solid-dosage pharmaceuticals, but one of the challenges for implementation is how to define a batch for quality assurance testing.   Read more »

Development in hot melt extrusion (HME) using twin-screw extruders to make solid-dosage drug forms has increased significantly in the past decade, although it is still in its infancy, said Charlie Martin, president of the US operations of Leistritz at the recent Pharmaceutical Extrusion Seminar organized by the company. An interesting aspect of HME is the variety of physical forms that can be given to the melt after mixing. Read more »

Improving bioavailability of poorly water-soluble drugs is an ongoing challenge for formulation scientists and is of crucial importance to advance clinically promising drug candidates. A Pharmaceutical Technology webcast, Bioavailability Enhancement through Lipid-Based Drug Delivery, will examine advances in lipid-based drug delivery systems for enhancing the bioavailability of absorption-limited small and large molecules. Read more »

Combustible dust is a fire and explosion hazard in many industries that handle dusty materials, including pharmaceuticals. Deadly dust explosions and how to prevent them have been a concern in the US and a focus for the US Chemical Safety Board (CSB) and Occupational Safety and Health Administration (OSHA) for the past several years. Read more »

Efficient energy consumption has taken to the friendly skies with a little help from the sun—and pharma. The Solar Impulse, a Swiss solar-powered airplane, is attempting to make its longest flight—from Switzerland to Morocco with a layover in Spain—in a 48-hour intercontinental test flight piloted by project originators Bertrand Piccard and André Borschberg.

Bayer MaterialScience became an official partner of the project in 2010, according to a May 24, 2012, press release. Since then, more than two dozen scientists at the company’s laboratories in Leverkusen, Dormagen, and Krefeld-Uerdingen, Germany, have been tasked with brainstorming ideas for lightweight construction and energy efficiency.

Read more »

The biopharmaceutical industry is increasingly turning to disposable, single-use systems that offer flexibility and cost benefits. This trend was evident at the Interphex 2012 exhibit in New York earlier this month in the disposable systems and components that were prominent in many booths. Exhibitors commented that disposable systems were unheard of at Interphex as little as six years ago, but now they are everywhere. Read more »

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story). As a result, digital signatures are becoming more commonplace throughout laboratories, manufacturing sites, and offices as companies search for ways to track and file processes, SOPs, approvals, supply chain movement, drug applications, and more. Quality management systems, much like our personal lives, are becoming far more digital and far less paper-based.

PharmTech discusses this issue and related compliance issues in a recent webcast, available on-demand here.