Pharma Open for Business

Time is of the essence when it comes to getting new products to market. Launching innovative solutions that address unmet customer needs is vital for success. The time companies have for product development is ever-shrinking, however. At the same time, technology is advancing more rapidly than ever and the quantity of relevant and information is expanding exponentially.  The most successful firms will be those that can leverage not only the latest technology advances, but also those anticipated on the horizon, while simultaneously accessing the broadest possible skill set and a comprehensive knowledge. In the global market that exists today, that means looking beyond the organization and utilizing all potential resources, or implementing an open innovation (OI) strategy.

Where does your company stand with respect to the OI concept? Do you collaborate with entities outside of your company – universities, institutes, government agencies, even individuals? Have you made use of the services of the various companies that have formed to facilitate OI? What has been your experience? Have you found that people in your company are resistant to bringing technology in from the outside for fear of losing their jobs? What has management done to allay such concerns? What have been some of the stumbling blocks? What about successes?

And don’t forget. If you haven’t already, you can sign up for the Pharmaceutical Sciences, Manufacturing & Marketplace Report here. Also check out the Pharmaceutical Technology/Biopharm International Marketplace at www.pharmabiomarketplace.com.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Pharmaceutical Asset Management: What is the Optimal Approach?

The pharmaceutical industry is undergoing many changes today, three of which in particular are having a major impact of the asset needs of drug manufacturers: the shift away from the development of blockbuster drugs to a focus on smaller-volume therapies that target diseases affecting sub-segments of the patient population; the increasing focus on biologic drugs at the expensive of small molecule APIs; and the growing adoption of single-use systems throughout the production process. The growing interest in continuous processing could perhaps be considered a fourth factor.

As a result of the evolution of the pharmaceutical industry, the conventional approach of constructing large, multipurpose, stainless-steel based facilities for large-volume manufacturing is not longer applicable for most of the drug products coming to market today. Interest in modular facilities that can be rapidly built in locations close to the targeted population is growing, particularly for biologic drugs. Smaller-scale single-use systems can also be more rapidly installed, often in much smaller spaces and in some cases in existing, non-purpose-built structures. We discussed such approaches for modular manufacturing in the Pharmaceutical Sciences, Manufacturing, and & Marketplace Report.

What, then, is to be done with the existing infrastructure? Is there a way to still leverage the equipment and facilities that exist? Is the only practical answer to shutdown these locations and minimize any losses? Or is there a way to breathe new life into older sites and process equipment in some way that will maximize the return on the investment?

What has your company done with older plants and production equipment that has been replaced with single-use systems or smaller, strategically placed modular facilities? Have you accessed the used equipment market, and if so, how have you leveraged these pre-existing assets? What are other options?

Gain a further perspective on asset management of pharmaceutical equipment in the Pharmaceutical Sciences, Manufacturing, and & Marketplace Report.

And don’t forget. If you haven’t already, you can sign up for the Pharmaceutical Sciences, Manufacturing & Marketplace Report here. Also check out the Pharmaceutical Technology/Biopharm International Marketplace at www.pharmabiomarketplace.com.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Extractables and Leachables Add Complexity to the Supply Chain

Parenteral drug manufacturers continually face the challenge of managing extractables and leachables (E&Ls) in their drug products. It is an ongoing problem because materials changes made all the way through the supply chain. The elastomers for tubing and seals, the plastics for containers, and the glass used in syringes all can affect the E&L profile of a parenteral drug. That means that new contaminants can be introduced at any time, and their identification and reactivity must be determined. That in turn means that extensive analyses must be carried out to ensure patient safety.

Clearly, increased awareness throughout the supply chain is critical to gaining some level of control over E&Ls. A recent article in the Pharmaceutical Sciences, Manufacturing & Marketplace Report examines advances in testing and controlling E&Ls.

But has the pharmaceutical industry done a good enough job at educating suppliers on this important issue? What do you think should be done to improve the understanding of suppliers far down the supply chain? What has your company done when working with your suppliers?

If you haven’t already, be sure to sign up for the eNewsletter so that you can read what experts in the field have to say. Then let us know what you think. Also check out the Pharmaceutical Technology/Biopharm International Marketplace.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Going Green

Did you know that proteins developed as therapeutic agents have been produced in plants since the late 1990s?  There have, in fact, been several biologics produced in transgenic plants, including gastric lipase, interferon, and insulin, that have entered human clinical trials. There are also clinical trials underway for cancer treatments based on proteins produced in plants.

The use of plants has several advantages over fermentation and cell-based technologies. There is no use of animal derived products or growth factors, and aseptic handling systems are also not necessary. No time-consuming identification and isolation of appropriate cell is required, either, so plant-based systems can be functional in a much shorter time. In addition, the biological features of bacterial, viral, and plant biology can be combined to achieve high yields and offer significant flexibility.

Have you utilized this technology? What was your experience? Do you agree that plant-based protein expression has significant potential? Or do you see problems with it, and if so, what concerns do you have?

If you haven’t signed up to receive it yet, take the opportunity right now. Just click here. Also check out the Pharmaceutical Technology/BioPharm International Marketplace at www.pharmabiomarketplace.com.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

X-Ray: Analysis: Seeing Straight Through

Any analytical method that can be carried out without damaging the samples is attractive for pharmaceutical manufacturers. It is not surprising, therefore, that interest is growing in industrial X-ray analysis. This nondestructive analytical technique offers both depth of penetration and reasonably high resolution, making it possible to capture the internal geometric data of a sample along with its density distribution, information that can be useful for process and design verification, product-quality analysis, foreign-material determination (metal, glass, organics), fill-level confirmation, and missing-components detection. In addition, with three-dimensional computed tomography imaging, it is possible to get a true three-dimensional view of the inside of a tablet, capsule, gelcap, or any type of solid or semisolid dosage form. Packaging materials–from medicine bottles to syringes–can also be evaluated.

What is your experience withX-ray analysis of solid or semi-solid dosage forms? Have you found it useful for identifying the source of inconsistencies in the disintegration of fast-dissolve formulations, or perhaps the improper functioning of your syringes or pill container seals? What other applications might there be for X-ray imaging in pharmaceutical manufacturing? What are its limitations? How might it be improved?

Don’t forget to sign up for the eNewsletter here if you haven’t done so yet. Also check out the Pharmaceutical Technology/Biopharm International Marketplace at www.pharmabiomarketplace.com.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report