Shri Thanedar, Ph.D., is the CEO and chief chemist of Avomeen Analytical Services. A veteran of the CRO industry, Thanedar has more than 25 years of experience supporting companies nationwide with services including method development and validation, chemical characterization, deformulation, extractable and leachable testing, stability and release testing, litigation support, and failure analysis services.
Avomeen Analytical Services was proud to exhibit at the 2013 AAPS Annual Meeting and Exposition in November. My team values this annual exposition as a tremendous opportunity to network with others in the industry. For me, the AAPS Annual Meeting serves as a meeting place for scientists from industry, academia, and government to collaborate with the singular focus of creating better medicine. To us, the conversations that arise at this event are often as valuable, if not more so, as the formal seminars and meetings.
Most conversations for my team centered on Avomeen’s primary analysis service of deformulation. This chemical analysis requires the breaking down of a sample to its basic components in order to both identify and quantify them. This complex technique attracted interest from attendees at the show and many people asked great questions regarding how it is used in the pharmaceutical development and manufacturing process.
While deformulation is quite complex and involves both the use of various analytical instrumentation, and expertise of deformulation scientists, the concept is quite simple. The process is used to determine a product’s ingredients and their quantities. This information is especially valuable when you are looking to reformulate a product to understand its formula, create a generic drug, or verify active and excipient ingredient characteristics.
The second most popular topic at Avomeen’s booth was that of pharmaceutical contamination and degradation. The presence of degradation components is one of the critical issues facing the quality of pharmaceutical products. When active drug molecules undergo degradation they can produce ineffective or possibly harmful molecules. Proper testing through mass spectroscopy, nuclear magnetic resonance, and many other techniques is necessary to characterize these degradants in order to isolate the problem components.
Other contaminants such as particles from machinery malfunctions or unknown impurities are fairly common problems in pharmaceutical manufacturing. Identifying these contaminants is a first step in contamination correction and quality assurance to ensure the safety of pharmaceuticals. At Avomeen, we do this through combined testing techniques such as high-performance liquid chromatography (HPLC) or gas chromatography and analyze the chromatograph to investigate unexpected peaks, which can be further characterized through mass spectroscopy. If this step is not conclusive, then we separate the contaminant use preparative HPLC and conduct further sophisticated characterization through techniques such as high resolution nuclear magnetic resonance.
Through the contamination testing process we have helped numerous pharmaceutical developers and manufacturers pinpoint contaminants’ origins thereby assisting in mitigating safety risks. At Avomeen we also offer failure analysis, leachable/extractable testing, and many other pertinent services for the pharmaceutical industry to guarantee pharmaceutical products’ purity and quality. By providing these services we seek to partner with pharmaceutical developers, manufacturers, and vendors to create formulations and maintain their excellence.
This collaborative approach characterized this year’s AAPS Annual Meeting and keeps us involved year after year. From seminar topics to the poster presentation, every aspect of the meeting pointed to the interrelation of the industry’s many contributors. Academics and researchers working with formulation specialists, manufacturers learning of new instrumentation and sterility practices: These conversations are ever deepening our understanding of the process from point zero to clinical trials and beyond. Such contribution from multiple avenues benefits not only those of us in the field but the end user. For as conversations expand, we continue to find better ways to create pharmaceutical products thus fulfilling our deepest desire.
Many thanks to AAPS for another great year and facilitating open conversation and education through every aspect of the 2013 Annual Meeting. We look forward to seeing everyone next year. For all attendees, please add your thoughts below in the comments and feel free to continue the conversation about deformulation, contamination analysis, or other services.