By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.
February can be a difficult month, even when the winter is as mild as the one we just experienced in much of the U.S. But, for anyone working in or observing the pharmaceutical industry, this February brought to a climax the swell of bad drug manufacturing news that had been building since last year. Some of the lowlights:
- staggering multi-billion-dollar fines levied against pharma;
- lawsuits against companies for failing to prevent drug shortages;
- lawsuits against FDA for failing to revoke the manufacturing rights of companies with drug supply problems;
- state actions to allow generic copies to be introduced during the patent exclusivity period.
I couldn’t help but think of Don McLean’s classic song, “American Pie,” as I shivered with every industry email that was delivered. Could there be other parallels? After all, the song was written as an elegy for simpler days. Is the drug industry at a similar impasse, looking back to the old blockbuster model as it faces increased global competition, inadequate quality systems and demands for lower cost, adequate supplies and better product quality?
Only a more scientific approach to manufacturing can get the industry out of this situation.
Consider biosimilars. FDA just released guidances which seem to be based on the best available science, and common sense. Only time will tell how industry will look at development and manufacturing, and how FDA will engage the firms and the process. Clearly, science, not nostalgia, must dictate practice.
Pharma has yet to go through the transformations that have marked other industries. Most dramatically, it still lacks a definition of “standard practices” that maximize efficiency through minimizing and reducing unique practices. After all, not every action need be a new discovery!
Pharma’s process steps have not changed over the decades. As a result, there is a persistent view of best practices as art rather than science. Every granulation, blending, cleaning, or bioreactor incubation process is considered unique to the product, and treated as one-off and special.
Could one make cars this way?
The Importance of ASTM E55
Back in 2002, in accordance with OMB-A119, FDA’s PAT team decided to focus on consensus standards rather than guidances. After consulting with all stakeholders, technical committee E55 was formed through ASTM International. The consensus process was identified as the arena to bring together subject matter experts and stakeholders and on equal basis where each held only one vote.
During the last eight years, E55 has grown, changed and adapted. It has been reactive to the pulse of pharma, but hasn’t lost focus.
The past four to five years have been the most challenging. Since few FDA staff members expressed negative opinions and attitudes, E55 members shied away from the debate inherent in the consensus process.
However, change is clearly in the air, signaled by completion of FDA’s staff manual guide, as well as references to standards in some of FDA’s key recent guidances.
At the same time, a small group engaged in biopharmaceuticals created a standard on the process inactivation of retrovirus by pH.
The work originated in ASTM technical committee E48, but has been transferred to E55, which is seen as a more appropriate forum discussing biopharmaceutical applications. E55, in turn, has created sub-committee 04 (E55.04) entitled “general biopharmaceutical standards.”
As spring signaled the season of rejuvenation, in March E55 members met at the White Oak campus in Silver Spring. Hosted by FDA’s Office of Pharmaceutical Science (OPS), the meeting was opened by OPS Director Helen Winkle, who reaffirmed FDA’s commitment to consensus processes.
E55 has also been busy reassessing its vision and its roadmap. The committee aims to add value by promoting a consistent yet flexible framework. Its standards activities will cover the entire product lifecycle; the portfolio will consist of science and risk-based standards, and describe a scientific framework to facilitate pharmaceutical development, manufacture, and adherence to quality and performance criteria. In addition, E55 will seek liaisons worldwide with all global stakeholders.
Although the road ahead is long, E55 aims to do for pharma what mass production and the Model T Ford did for the automotive industry.
If you haven’t done this already, I urge you to study OMB-A119 and become an active participant in consensus standards.
Continuing in the old fashioned “one-off” approach to drug manufacturing can’t work for much longer. The levee is dry.
If you need convincing, please contact me at firstname.lastname@example.org.
image courtesy pandc.org.ua
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