“Frequently time is of the essence. It is necessary to evaluate, in a short time span, the stability of a product change, and here, the design of stress conditions which will accelerate decomposition in a meaningful way is necessary. This is a difficult task and one very particular to the stability scientist.” J.T Carstensen. Defining stress testing and its role in stability: what does it show? Stress testing is a fundamental requirement in all drug development programs. It provides evidence …
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Mass Balance – What, When, How?
This “fishbone diagram”, shown by permission from Steven Baertschi (S. W. Baertschi et al, Trends in Analytical Chemistry 49 (2013) 126-136), lay’s out everything that could impact mass balance in a study of pharmaceutical stability and degradation. For our team, this is a problem solver’s map of the world: What is mass balance? When we add together the assay value for the drug and the adjusted responses of all the degradants, they should equal the initial value – mass …
Increasing Productivity in a Chromatography Lab
Learn from the chromatography experts how to increase efficiency when using SFC. Paul Lefebvre, Lab Director, Averica Discovery, presented at the AkzoNobel Kromasil Prep Symposium 2018 on: ‘FAST, SCALABLE, PREPARATIVE SFC: MAKING THE SEPARATIONS LAB MORE EFFICIENT’ Download your copy now
Neopharm Labs Acquires Averica Discovery
Today Averica Discovery announced its acquisition by Neopharm Labs, an analytical testing lab based out of Quebec. Together the companies offer a full range of services that cover every stage of the drug development cycle including R&D, method development and validation, impurity isolation and profiling, stability testing and management, and commercial testing in chemistry and microbiology. Excerpt from Press Release – “Our clients can now take advantage of an expanded range of services,” adds Dr. Jeffrey Kiplinger, President and …
Journal of Chromatography – New Issue on Enantioseparations
Shout out for the new issue of the Journal of Chromatography – it’s on chiral chromatography! Available wherever such products are sold (the Harvard Coop?)… or on the interwebs, of course. First papers I read : Preparative supercritical fluid chromatography: A powerful tool for chiral separations David Speybrouck, Emmanuelle Lipka Comparison of liquid and supercritical fluid chromatography mobile phases for enantioselective separations on polysaccharide stationary phases Syame Khater, Marie-Anne Lozac’h, Isabelle Adam, Eric Francotte, Caroline West Toward structure-based predictive tools for the …
Averica Answers: Can You Capture a 0.01% Impurity?
Averica Answers is a series of short videos that each tackle a question we are often asked. In this video, Paul Lefebvre discusses trace impurity isolation. We do like to work with the customer to define a source of enriched material. Once we define that source of material it becomes easy to work with. Now to say, if we had to work with something that was at a very low level, that means is it’s detectable. Because it’s separatable, we …
Averica Answers – What is Averica’s Approach to Impurity Isolation?
In this video, Paul Lefebvre discusses Averica’s approach for targeted isolation of impurities. The stability indicating method is the gold standard for figuring out what’s what. That’s what the customer is using to identify and quantify all the impurities that they have. What we do is we kind of squish everything together, process a lot of material really fast, and chop it up. Then we take the pieces and we analyze them by the gold standard. And, we see …
Averica Discovery Expands Capabilities and Capacity by 50%
Enhances ability to supply early drug development programs while shorteningproject timelines MARLBOROUGH, MA, June 2, 2016 – Averica Discovery Services Inc., an analytical development contract research organization (CRO), today announced new hires and the acquisition of new equipment that significantly expands the Company’s capacity and capability. Averica offers analytical development services to pharmaceutical companies; supporting new drug profiling, early to mid-stage clinical development, and CMC. Averica filled three new laboratory positions, and added new instrument systems: a new preparative Supercritical Fluid …
5 Ways to Prevent Impurity Isolation Scope Creep
Contracting tough projects with a CRO always requires active management, but some projects are complex enough that scope creep is a common problem. Impurity isolation falls into this category – the target impurity is an unknown, present at an uncertain level in a sample, and may not be stable. It’s a fun problem for the analytical team, but a headache for a project manager. Here are five tips on controlling scope creep in impurity isolation projects: 1) Start …
Life Science Marketing Radio Interviews Olga Torres
In an inherently highly technical and highly customized contract research space, Olga Torres, Director of Marketing at Averica, developed a marketing plan that very successfully engages people based on Averica’s online presence. In the Life Science Marketing Radio interview, Olga shares the importance of marketing for a niche life science business and lessons learned along the way to digital credibility. Click to link to podcast page, containing audio and transcript. Life Science Marketing Radio, hosted …