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Manufacture Ingredients, Quality & Compliance, Small Molecules, Supply Chain, Formulation

A Lifetime of Achievement

What was your first professional job?

In 1977, without having insight into what an excipient was and with only an undergraduate degree in chemistry to my name, I accepted a job offer from Colorcon. I began working for the company just two weeks after graduating. It was an exciting time for me as a young analytical chemist and I enjoyed learning about an area of the industry that had previously been completely unknown to me!

Colorcon was a small company at the time (I was employee #112). Though the company was relatively new, it was beginning to grow significantly in terms of size and recognition as a major supplier to the pharmaceutical industry. During the day, I learnt about excipients at work, and in the evenings, I attended night school at Villanova University to get my master’s degree. The opportunities for academic and professional growth really helped me manage and grow into my new role.

How did regulation become an integral part of your career?

My early role was as a green bench chemist checking that our excipients met the company’s quality standards. Relatively quickly, I progressed from Manager to Director of Quality Control for North America. The company had no separate regulatory department back then, so I ended up splitting a lot of my time between my own role and providing regulatory support for the company to assist our customers and our own internal R&D groups. It wasn’t until 1995 that the company developed the in-house regulatory department, which helped us share our expertise in the field of excipient design, and international regulations across the industry.

You’ve also been very much involved with IPEC…

Correct! I’ve been involved with the International Pharmaceutical Excipient Council (IPEC) from its founding in 1991, and I am sincerely proud of the association’s accomplishments. Our early goal was to harmonize compendial standards for excipients, as well as GMP guidelines and safety evaluation guidelines. It is incredible how much IPEC has grown over the years. And through my involvement with IPEC, I became more deeply involved in Colorcon’s regulatory affairs. It’s an area I am very passionate about; it’s so important that we continue to improve the regulatory framework surrounding excipients so that excipient manufacturers know what is expected of them, and pharmaceutical companies understand the realities of excipients when formulating drug products.

How did it feel to receive IPEC’s Louis Blecher Outstanding Lifetime Achievement Award?

Receiving the award came as a complete surprise to me, as it requires a nomination to be submitted to the Foundation’s board detailing the significant contributions an individual has made to IPEC. Though I was blindsided, the award carries sentimental value for me. Lou was a close friend of mine until he passed away in 2008. Having known Lou – and his passion, enthusiasm and drive to change the way an entire industry looked at excipients – made winning the award even more meaningful. He was the one who brought us all together to found IPEC. In those early days, he dubbed me “The Young Scientist” for my penchant for piping up from the back of a meeting with questions and comments. I was often the youngest person in the room but didn’t shy away from letting my voice and ideas be heard!

Lou was the first recipient of the IPEC Foundation Chairman’s Award, which was created to reward individuals who have made substantial contributions to the field of excipients. The award was renamed in his honor.

How would you like to see the industry progress?

Formulators weren’t vocal enough in the past to hold the attention of the industry when talking about the importance of excipients. But over recent years, regulators have thankfully become more aware of how essential the quality of excipients is to the overall quality of drugs produced. Unlike APIs, excipients are not pure. They are made of multiple components, including additives and residual processing aids that are inherent to the way that these products are made, all of which have the potential to have significant effects on their performance. In our experience, pharmaceutical companies will often be tempted to buy from cheaper sources so long as the excipients meet US Pharmacopeia specifications for drug development, disregarding the fact that the compositional differences between excipients can impact the final drug product.

IPEC seeks to help formulators understand that underpinning the variation seen in their finished drug products requires an understanding of the inherent differences caused by using excipients from different suppliers. The materials may meet the same basic specifications, but without doing all the same studies (e.g., stability, compatibility) with each supplier’s material during the original drug development, the materials are not interchangeable. IPEC has published a guideline in this area, “The IPEC Excipient Composition Guide 2009” and I have personally delivered seminars to help drive conversation around this issue and change the perception that certain excipients from multiple suppliers are fine to use as substitutes so long as they meet the broad specifications that are currently listed in the pharmacopeias. We hope that this will help users and makers communicate better as it relates to excipient composition profiles and the impact that compositional differences may have on drug manufacturing and performance.

Despite the challenges we face, I can see change happening in the industry and this makes me very optimistic about the future of the field. We still have a long road ahead of us, but I know that so long as we continue to make our voices heard, more progress will be made. In the 30 years that IPEC has existed, it has revolutionized the way excipients are viewed. Here’s hoping that the next 30 years will be just as successful!

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About the Author
Maryam Mahdi

Deputy Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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