Enron - A Lesson for Lyophilization

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Enron - A Lesson for Lyophilization
Fall 2003
Thomas A. Jennings, Ph.D.
Phase Technologies, Inc.
APR
On September 11, 2001 the United States experienced a disaster unparalleled in our history. The impact of that disaster is still being felt and all one can say is things will never be the same again. While the country was trying to recover, it was hit with yet another blow that was not perpetrated from those outside the country but from those within the country. It was the sudden and unexpected collapse of a giant energy company known as Enron. While the collapse of Enron in itself did not cause the dramatic loss of life that was experienced during September 11th, it nonetheless affected the lives of countless numbers of individuals and, most sadly, the very employees in the company who had invested their financial future of that company only to see it disappear almost overnight.
I do not know enough about the collapse of Enron to determine if any illegalities were involved, but there are some facts that have been made public. Perhaps the most disturbing, at least to me, is that a well respected and trusted accounting firm was involved. This firm appears to have known of the questionable accounting practices that were being conducted by Enron and either condoned or ignored the warning signs that such practices could bring down this giant energy company. If any general statement can be said, this was, at a minimum, poor upper management that not only caused financial harm to so many innocent people but also took from them their livelihood - their very employment.
Now you may wonder how the disaster of the collapse of Enron would have any bearing with lyophilization. After all, if there is any blame to be placed it would be directed at the upper management of the company and not to those who worked at a lower echelon. Certainly it would be a surprise to many people to see the CEO of a large pharmaceutical company at the controls of a freeze-dryer. That is precisely why I thought it necessary to write this article. For, with lyophilization, the upper management of the company may not know if the well being of the company could be in any way jeopardized by something related to the lyophilization process. In this case, it is upper management that may not be aware of what is occurring at the lower levels. Therefore, it will be the objective of this article to point out some key areas in the lyophilization of products where the Enron syndrome may be applicable.
The single main area where upper management may lack a clear understanding is that associated with validation. Undoubtedly, upper management is well aware that validation for good manufacturing practices would not only satisfy the requirements of any regulatory agency, but they would also be simply good business. In the minds of the upper management, good manufacturing practices are analogous to good business practices. Here is the question that the reader must ask: Is the upper management safe in assuming that everything is under control when it comes to manufacturing a lyophilized product or are there perhaps some areas that they should be concerned about?
Process Validation
Perhaps my greatest concern lies in the area of process validation [1]. Given that the top management takes a keen interest in this area, they may well follow the development of the product from its conception during the early stages of research and development. With all indications that the product will not only benefit those suffering from a given ailment or perhaps detect the early stages of a disease and thus catch it at an early stage where it is curable, it will prove to be financially rewarding to the company. So in such a win-win environment, the management approves to commit large amounts of funds and resources to undertake further development and finally clinical trials. What could be years later, and after the spending of a considerable amount of company funds, the product is awarded a license to go into production. So it must be with great satisfaction that the company starts the process to recover its outlay of funds for this product and also for products, for one reason or another, that did not make it through the clinical trials. Yet what a shock it must be for the company and its stock holders, when they receive a warning letter stating that the validated process obtained during the development of the drug does not agree with the ?validated? process used in production of the product. This is a warning letter that they as the top management team must now try to answer. Thus, the key management is faced with an Enron situation, where the issues are not obscure accounting practices but a major difference in process resulting from problems with the scale-up of the product from a development dryer to a large production dryer. Unless, those in the lower echelon can quickly recognize the problem and solve it, the company may be forced to halt production until the problem can be solved. Even if the problem is quickly solved, the fact that such a letter is a matter of public record can only be viewed as being detrimental to the image of the company. To avoid such an Enron effect, those responsible for validation and transfer of the process must be especially careful that the techniques used in the validation of the process are universal and applicable to all dryers [2].
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