Turning Challenges into Opportunities

Legislation in both Europe (EU Directive 2011/62/EU) and the US (California’s e-pedigree program) that is designed to help control the transportation of pharmaceuticals across borders and fight the distribution of counterfeit drugs will soon be coming into effect. The need to ensure patient safety is a key driver behind such legislation.

While the requirements can be onerous for pharmaceutical manufacturers, there also may be potential benefits beyond the critical one of eliminating dangerous counterfeit medicines from the marketplace.

All that serialized data that must be collected, monitored, and controlled – if managed properly, may be useful for not only achieving regulatory compliance, but also increase supply chain visibility and control, improve a company’s decision-making ability, and, ultimately, reduce costs and increasing profitability.

How do you look at the need to implement track and trace solutions? Do you see a challenge or an opportunity? What progress have you made so far? Have you overcome any hurdles and gained insight that others could benefit from? Share your thoughts and experience!

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Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Guiding Cocrystal Development

Cocrystals offer pharmaceutical manufacturers an alternative method to using salts or hydrates for obtaining a crystalline solid form of an API with desirable stability and dissolution behavior.

Recently, the FDA issues its final regulatory guidance on cocrystals (http://www.fda.gov/downloads/Drugs/Guidances/UCM281764.pdf).

Even though nearly all commenters requested that the FDA not classify cocrystals as 'drug product intermediates' but as salts, the agency elected to keep this definition in the final guidance.

Why were so many opposed to this approach, and what impact might the FDA’s decision to retain this classification have on the eventual acceptance of cocrystals in drug formulations?

There is significantly more information required for drug product intermediates, In addition, the decision could benefit generic companies, which may be able to use cocrystals as a means to get around patents. Thus, in the short and long term, this decision may deter branded pharmaceutical manufacturers from developing formulations based on cocrystals.

What do you think of the FDA’s final guidance on cocrystals? Will it have an impact on their further development? Or do you  think the performance benefits that can be gained in certain cases by using cocrystals will outweigh the additional testing and reporting requirements and the potential longer-term threat of generic competition?

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

Out of the Box Thinking

New simple-to-install, universal connectors for asceptic parenteral manufacturing are making it much easier for pharmaceutical manufacturers to combine single-use technologies with permanent, stainless-steel systems and/or with other single-use systems from different manufacturers with different coupling requirements.

This type of connector makes it possible to shrink the footprint of manufacturing operations in the clean room and reduce the steps necessary for achieving sterile manufacturing. Both advantages add up to improved efficiency and productivity.

However, there are even greater potential benefits if this type of technology can be shown to provide an asceptic connection outside of the clean room.

Do you think connector technology can achieve such a level of sterility assurance? What type of evidence would you need to be convinced? Would you then feel comfortable using them outside of the clean room in order to leverage the numerous efficiency, productivity, and cost gains such an approach would make possible?

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

Analysis the Terahertz Way

Terahertz waves are low energy waves that can penetrate up to a few millimeters into substances and detect interactions on the molecular level (intermolecular hydrogen bonding or intramolecular interactions in large biomolecules like proteins), the microscopic level (film thickness, interfacial interactions) and at the structural level (density and porosity), all non-destructively.

These capabilities seem to be a perfect fit for the pharmaceutical industry. So why isn’t the technology more widely used?

Early instruments were unwieldy with respect to their size, for one thing. Advances in the laser, emitter and detector technologies required for the generation of terahertz waves have made it possible for instruments today to be of a practical size. Cost has come down as well, and now is at a reasonable per measurement level. Instrument manufacturers are also now offering easy-to-use platforms for terahertz analysis.

Of course, there is also the fact that the pharmaceutical industry is conservative and takes its time when considering the adoption of new technology. Just look at Raman analysis and where it was 10-15 years ago, and how it has become a much more commonplace analytical tool today.

What do you think about terahertz spectroscopy? Is your company interested in this technology? Have you used it in your product development of processing operations? Have its capabilities won you over, or do you still have concerns? How easy is to interpret the results? Do you see it as an alternative or substitute for some existing analytical techniques?

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