Glass delamination(1) has become a bit of a hot topic in the area of parenterals over the past several years. Glass delamination is, indeed, a serious issue which can not only cause pharmaceutical companies millions of dollars in recalls, but also stands as a safety hazard to end users. Delamination is essentially the flaking off of the top layers of a glass surface into the liquid contents of a pharmaceutical vial, syringe, or other container. Numerous companies have experienced this issue, and have had to open investigations(2) to address the issue. The question is, how can we be proactive, rather than reactive, in addressing concerns with glass delamination? How can we minimize the risk of experiencing a delamination issue, in order to protect the welfare of end-users and uphold the quality of our products?
Gateway Analytical has teamed up with researchers from the Division of Pharmaceutical Analysis at FDA/CDER to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products. This study was performed to address aqueous nasal spray suspensions stability during long-term shipping/storage. During the study, suspension formulations were subjected to temperatures that may possibly be reached inside shipping containers during hottest and coldest months in St. Louis, MO.
Original Event Date: Tuesday, December 17, 2013
Duration: 60 minutes
Presenters: David Exline, Senior Vice President & Antonio Scatena, Laboratory Manager at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical
On November 20th, Antonio Scatena, Laborator Manager and Cara Plese, Scientist at Gateway Analytical hosted a webinar designed for scientists working in the pharmaceutical industry. During this webinar, they discussed the advantages of using Raman analysis in conjunction with other analytical techniques, such as microscopy, SEM/EDS and FTIR in investigations to identify unknown materials. They discussed the sample types that are best suited for Raman analysis and tips on how to discover the best parameters to use for you investigation. They also discussed how Raman Analysis can be used to analyze inorganic materials, such as metal oxides, pigments and minerals which would typically not yield results with FTIR analysis.
Recently, the American Association of Pharmaceutical Scientists (AAPS) released a post on their blog authored by Binodh DeSilva, Executive Director of Immunochemistry and Biomarker Development and Mark E. Arnold, Ph.D., Executive Director of the Bioanalytical Sciences and Selective Integration Department at Bristol Myer Squibb on the FDA and industry discussing crucial draft bioanalytical method validation guidance. Here is an excerpt from the post:
For the third consecutive year Gateway had the pleasure of exhibiting at the AAPS Annual Meeting, which was held this year in San Antonio, at the very large Henry B. Gonzalez Convention Center. AAPS members and attendees come from a wide range of areas within pharmaceutical drug development and biopharmaceuticals. In addition to offering free popcorn daily and an open bar on Tuesday night, this year, our focus was to promote analytical services that not only support drug product formulation development but also address manufacturing issues such as particulate contamination and source determination.
Published in Inhalation Magazine’s (www.inhalationmag.com) August 2013 issue featuring Rebekah Byrne, Scientist and David Exline, Senior Vice President of Gateway Analytical
Original Event Date: Wednesday, November 20, 2013
Duration: 60 minutes
Presenters: Cara Plese, M.S., Scientist I, & Antonio Scatena, Laboratory Manager at Gateway Analytical
On August 28th, Cara Plese, M.S., Scientist I and David Exline, Senior V.P. at Gateway Analytical hosted a webinar designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of tablet and semi-solid drug products. During this webinar, our presenters provided examples of commonly found contaminants in tablet and semi-solid drug products and how these contaminants are introduced into the manufacturing process. They presented a basic multi-tiered analytical approach to characterize foreign particulate matter and how to solve particulate contamination issues using a scientific approach. The importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination was also discussed.