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Technology Impacts ICH Q3D Compliance Testing

Chemist PouringA little known fact about testing drug products and excipients using USP 232/233 monographs for compliance to ICH Q3D Guidelines is that analytical interferences can be present resulting in non-compliance. Brooks Applied Labs has specialized in the testing of metals and metalloid compounds for over 30 years culminating in a robust understanding of what interferences may be present, both chemical and spectral, and how to mitigate them. An excellent example is that the introduction of oxygen gas to produce the AsO+ anoalogue during ICP-MS analysis has been established as the gold standard for arsenic quantitation. Does your CRO currently support this technology? BAL offers educational webinars to empower our pharmaceutical partners with information for making the most educated decisions possible. Contact us today to revolutionize the way your enterprise approaches supply chain CRO selection and experience the BAL difference.

 

 

Elemental Quality Perspectives for Chemically-Defined Media

BioPharma SolutionsWhen an out-of-specification (OOS) event is encountered, investigative teams often direct their initial focus on physical attributes of the production cycle. Sifting through temperature logs, calibration data, and personnel training records can only get you so far when pursuing a root cause analysis. An often-overlooked fact is that biologically-derived pharmaceutical drugs rely upon controlled chemical environments for both production and drug viability.  Minute differences in both micronutrients and contaminants play a key role in mitigating OOS events, as well as optimizing yield and maintaining drug efficacy. To protect their investments and maximize profitability, pharmaceutical companies must incorporate chemistry quality testing beyond what their supply chain can typically support. Brooks Applied Labs has been supporting the pharmaceutical industry for over a decade in not only understanding complex chemical systems but also providing analytical services at highly specialized levels.

Micronutrients and contaminants play antagonistic roles for all organisms, which is why it is imperative to monitor for small changes in concentrations in each lot of chemically-defined media. Chemically-defined media contains a plethora of components, from salts to amino acids and transition metals, and each chemical must be monitored for both the target concentration of metal and metalloid micronutrients but also non-target (contaminants) elements which can be cytotoxic.

The first step to integrating chemistry into quality systems is requiring that each lot for every component applied to chemically-defined media has a subsample that is retained for future investigative analyses. The next stage is to ascertain if the appropriate acid-cleaned container was used for storage (also offered by BAL). By working with in-house scientists, as well as the experts at BAL, a list of elements can be generated that includes both micronutrients and possible contaminants. Understanding that the concentration of elements in the final chemically-defined media is cumulative and impacted by each component, analytical data objectives must be defined. Validated methods must then be referenced to ensure compliance. Finally, a rigorous testing regimen needs to be defined and adhered to.

Of course, the aforementioned approach to the modification of a quality system is simplistic and the actual implementation will require significant resources. However, the outcome will be a more robust quality system with an increased confidence in profitability for current and future lines of drugs. If you are currently in a state of duress over an OOS event or are compelled to mitigate future ones, contact us today. In the world of pharmaceutical drug manufacturing, time is money, and our job at BAL is to advance your interests as fast as possible.

BAL’s TMP Lead Ties the Knot!

Emily Trevor WeddingOn August 3rd, BAL’s Trace Metals, Pharma Group Lead, Emily Seeley, married Trevor Prophet, a Membership Director at the Northshore YMCA in Bothell. Their celebration took place in Port Ludlow, WA, next to the water with mountains in sight surrounded by friends, family and their pup Pepper. The happy couple spent the following week honeymooning along the Washington State Coast. All of us a BAL wish you both the best of wishes in your new chapter of life together!

Se and Hg in Fish Collected Near Power Plants

Arsenic SpeciationBrooks Applied Labs’ data was featured prominently in a recent Environmental Toxicology and Chemistry journal article titled, “Selenium and Mercury in Freshwater Fish Muscle Tissues and Otoliths: A Comparative Analysis”. Authors Robin Reash et. al. presented a study where they measured mercury (Hg), methylmercury (MeHg), and selenium (Se) in muscle tissue and otoliths from 12 species of fish collected from locations influenced by power plant wastewater. There were interesting differences between Se and Hg in their correlation between concentration in the tissues and otoliths and ecological/exposure factors, perhaps explained by the different manners in which Se and Hg bioaccumulate. For more information, the full abstract can be viewed on-line. Visit the BAL website for more information regarding the vast array of analytical services available for biological tissues

Welcome to the Selenium Centre of Excellence

Selenium Centre of ExcellenceThe Selenium Centre of Excellence (SCE) is a non-profit organization seeking to advance innovative scientific solutions to address the growing global concern of selenium for the betterment of its inhabitants, ecosystems, industry, and regulatory bodies. Forever altruistic, Russell Gerads (BAL’s Business Development Director) is a member of the SCE Steering Committee, where he helps to guide operational and research activities. Membership to SCE is open to anyone that shares the organization’s goals and belief that technology, science, and engineering can help solve many of the issues associated with selenium. Please contact Frank Gu (f.gu@utoronto.ca or 416-978-8518) for more information about the SCE, or visit our website to learn more about BAL’s speciation and analysis capabilities for selenium.

Welcome Baby Nyah to the BAL Family!

Nyah Marie GreavesBrooks Applied Labs is happy to announce that Client Services Manager, Lydia Greaves, and her husband, Lionel Greaves IV, welcomed their baby girl, Nyah Marie Greaves, to the world on July 23rd. Big brother, LGV, just adores his new baby sister! Nyah even got to attend her first BAL Summer Picnic last weekend, which she slept through like a champ! We look forward to welcoming Lydia back from her maternity leave in mid-October. Congratulations from all of us at BAL on the new addition to your family!