Going Modular

Modular biopharma facilities seem to be attracting a lot of attention these days because of the rapidity with which they can be constructed. Many also incorporate single-use technologies, so not only is time saved, but there is also the potential for reduced capital investment.

Beyond these obvious advantages, the availability of such modular factories creates opportunities for biopharmaceutical manufacturers to install facilities in locations they might not otherwise have considered. With the lower capital investment and ease of construction, it may be possible to construct multiple, smaller production facilities, thus enabling more localized and customized service. In addition, with the growth of niche medicines with smaller volumes, the ability to cost-effectively construct smaller operations more quickly and at lower cost can help manufacturers reduce their time to market and maximize their profitability.

Has your company opted to build a modular biopharmaceutical manufacturing facility? What has been your experience? Are there really significant cost and time savings? Do they functionally equally as well as a conventional, “brick and mortar”   facility? What issues have you come across? What good experiences would you want others to know about? Do tell!

  

And don’t forget. If you haven’t already, you can sign up for the Pharmaceutical Sciences, Manufacturing & Marketplace Report here.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

The Benefits of Biodegradability

Interest in biodegradable polymers is expanding rapidly in a wide range of industry sectors and as growing numbers of polymer-chemistries become available. The pharmaceutical industry is no exception. In fact, there are significant benefits to the use of biodegradable polymers in formulated drug products that go well beyond their sustainability, which is what is, in large part, driving the use of such polymers in other sectors.

Biodegradable polymers are, in fact, ideal for the development of sustained release parenteral products or the taste masking of tablets, capsules, and granules. In the case of parenterals, the ability to provide sustained release increases ease of use and may in turn leader to greater patient compliance.

Biodegradable polymers are also being investigated, in conjunction with nanoparticle conjugates, for targeted drug delivery of highly potent APIs. They can even be used to provide sustained release of antibiotics or anti-inflammatory or other actives at the site of surgery or on an implanted medical device.

What is your experience with biodegradable polymers? What applications for these materials are you investigating or would you like to see explored? Let us know.

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.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Can a Process be Too Productive?

Advances in monoclonal antibody (mAb) production have superseded the abilities of downstream processing systems. Current production systems generate much higher concentrations that cannot be handled by traditional separation processes. Whether it is ion-exchange columns or centrifugation systems, processing solutions with higher biomass has become a real challenge for the industry. At the same time, the growth in the biosimilar market is placing downward cost pressures on these downstream processes.

What do you think can be done to address this issue? Is enough progress being made with salt-tolerant and mixed-mode ion-exchange media? Will introduction of single-use systems be effective in reducing costs in general? What about the use of flocculation and precipitation? Membrane technology?

Beyond specific new technology solutions, what new strategies might be adopted to help overcome the challenges faced by mAb producers?

Share  your thoughts and ideas.

Don’t forget to sign up for the eNewsletter here if you haven’t done so yet.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

INTERPHEX Lesson: The Little Things Really Do Count

In meetings at INTERPHEX, and even while just observing the wide range of equipment offerings on display at the show, it struck me quite strongly that pharmaceutical product quality often relies to some degree on very small parts and components. My experience has largely been related to the chemistry and processing of APIs, and not so much with the physical equipment involved in their final formulation.

Not only is the vast array of required machined parts and the level of detail to which they have been developed quite impressive, the potentially significant impact that even a little wear or damage to these small parts can have on product quality is quite something. As a result of this recent education, I have a new appreciation for the complexity of pharmaceutical manufacturing equipment and the work required to properly maintain it.

Do you have strong feelings about a type of manufacturing equipment that you feel doesn’t receive the recognition it deserves? Let us know.

And what insights did you take away from this year’s INTERPHEX? Did you spot any significant new trends (the growing use of x-ray and terahertz analysis techniques), regulatory concerns (the push for serialization) or facility design issues (modular systems), or something all together different? Share your thoughts!
                                                   

Don’t forget to sign up for the eNewsletter here if you haven’t done so yet.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report