Request For Authors

Calling all pharmaceutical industry experts with valuable knowledge on important subjects and a passionate opinion to go with it: I want you to contribute to this blog or to write an article for the Pharmaceutical Sciences, Manufacturing & Marketplace Report!

Has your company developed a new characterization technique that could reduce production times and help lighten the burden on pharmaceutical QC labs? Have you used a tried and true excipient in a new way that formulators could benefit from? As a biosimilar manufacturer, are there specific technologies that you find help ensure consistent quality that matches the branded drug?

Take this opportunity to demonstrate your expertise to an interested audience. As a journalist with a chemical background and many years of working in the fine and specialty, coatings, pharmaceutical, and related industries, I am in an excellent position to speak with industry experts and synthesize and organize their thoughts and perceptions. But I would like to add to that service by providing direct insights from the experts themselves.

Please contact me (PSMMREditor@gmail.com) with your proposed topic. 

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

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Mixing It Up

Mixing technology seems like a basic capability with little room for further advancement. Nothing could be further from the truth. Whether working with just solids, solids and liquids, or just liquids, there are numerous factors that must be considered when combining different materials. For solids, there is particle size and size distribution and the stability of the particles. When mixing a solid and liquid, the dissolution rate of the solid and the viscosity and shear stability of the liquid are important. Suspensions involve yet another set of variables.

As a result, each mixing process is unique and requires unique parameters and process conditions.  Recognition of this fact can lead to improvements in mixing and blending processes for even the simplest ingredients.

Have you had such an experience you can share?

I am also curious about the adoption of newer mixing technologies by the pharmaceutical industry.

For example, is resonant acoustic mixing (RAM) (from Resodyn Acoustic Mixers), which is an impeller-free mixing technology that uses propagation of a low frequency, high intensity acoustic wave through the material to cause both bulk flow and micro-scale mixing, appropriate for mixing of pharmaceutical formulations, or is it only suited for mixing processes related to the manufacture of intermediates and APIs?

Are there any other novel mixing methods that are finding use in the pharmaceutical industry?

Any ideas? Let me know!

And maybe I’ll see you at INTERPHEX. Stop by the Pharmaceutical Technology booth (#4139) to say hello!

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

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Gearing up for INTERPHEX

INTERPHEX 2013 is just around the corner, and the show looks to be as big and busy as ever. Our April 24^th issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report discuss advances in various types of equipment used in the pharmaceutical industry, from mixing and blending equipment for solid dosage forms to visual inspection equipment for parenterals and the use of microreactors for chemical API manufacturing.

According to a survey of members of the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable, which was conducted in 2012 (1), that although implementation of continuous processes in pharmaceutical API manufacturing is not a standard practice as of yet, eight of the nine responding companies have taken a continuous process to the pilot plant or production scale. The survey also identified several reasons for implementing continuous processing, including simplification and increased speed of scale-up, increased throughput, and increased safety, reduced waste, greater process control, and overall cost savings.

The problem, of course, is that continuous processing, and particularly the use of microreactors, is a new technology that requires significant investment. With existing capacity and facilities in place for batch manufacturing, it is hard to argue for additional investment even though the benefits are measurable.

Manufactures of microreactors have made progress in addressing many of the concerns associated with their systems. Modular reactors have been introduced that can be fit for different reaction processes and run in parallel to address scale-up needs. Issues, however, remain, such as the need for large numbers of connectors and uncertainty about flow distribution. Integration with downstream processing is also a consideration.

It seems, though, that the use of some sort of flow chemistry for continuous chemical synthesis will eventually be adopted in some form.

Are you surprised by the survey results? Or does your experience fit well with the experience of these pharmaceutical manufacturers? As a microreactor manufacturer, how are you addressing concerns regarding the technology?

You can read more about microreactors for continuous chemical manufacture in the April 24^th issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report.

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 A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Reference

1. P. Poechlauer et al., Org. Proc. Res. Dev. 16 (10), 1586−1590 (2012).

Biologics in the Spotlight

The 2013 BIO International Convention takes place this month in Chicago, Illinois. Since cell-culture media are such a critical component for the manufacture of biologics, the fourth issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report includes a roundtable discussion on this subject, with comments on trends in media development from leading manufacturers.

With respect to media for protein expression, the focus, it seems, has moved from increasing protein expression yields to ensuring product quality by gaining better control over the makeup of the cell- culture media. That means closer scrutiny of raw materials and investigation of the effect of each of the numerous media components on cell performance, which has led to increased investment in and development of characterization techniques.

Of course, there is also growing demand for culture media used for the production of therapeutic cells. The media needed in these applications must be carefully designed to encourage proliferation without specialization until the desired time. Isolation of the cells, which tend to be fragile, requires much gentler downstream processing conditions.

The use of chemically defined media seems to offer a solution in both applications. Manufacturers can characterize individual raw materials and ensure that they meet specifications and perform as needed.  The key will be the ability to achieve accurate characterizations and develop methods that allow researchers to make connections between specific component properties and certain cell performance parameters.

Are there technologies available today that can achieve these goals, or do existing characterization techniques require modifications to be of maximum use? How do you evaluate the performance of your cell culture media? What do you expect from your media supplier along these lines?

We’d like your opinion. And suggestions of topics related to biologic API manufacture that you don’t believe receive the attention they should. Think about writing a guest blog – I welcome your input.

Look for the fourth issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report this week. If you haven’t signed up to receive it yet, take the opportunity right now. Just click here.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

A Look at Freeze Drying of Parenterals

With the annual meeting of the Parenteral Drug Association coming up this month, we have elected to feature advances in freeze drying in our the upcoming first April issue of the Pharmaceutical Sciences, Manufacturing & Marketplace Report.

Freeze drying, or lyophilization, has been used for many products, beginning with blood plasma products, antibiotics, and vaccines. As the number of biologic drugs, and thus parenterals formulations, has increased in recent years, lyophilization technology has also become more widely used. While the industry has a better understanding of critical issues today and equipment capabilities have improved to address some of these issues, there is much that remains unknown. In addition, as freeze drying is used for greater numbers of high value products, further technical demands will arise.

Even simple questions – such as when lyophilization is appropriate – need to be addressed as potential new applications present themselves. There will be both formulation and process-related issues to consider: protein/nucleic acid stabilization in the solid state, heat transfer, nucleation, vial fogging, handling of high concentration formulations, reconstitution, scale-up, characterization and analysis.

Will new dryer designs address these issues? Or will changes in formulations be the key? Do excipients have a role? What new characterization techniques might be of value?

Share your thoughts. Also, please suggest other topics related to parenteral manufacturing that you feel are not well-covered but could be useful to our readers – especially on new technologies that others can benefit from. You are the experts. Help me make the Pharmaceutical Sciences, Manufacturing & Marketplace Report as valuable a resource as possible.

And 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