Major impurities in a drug product should ideally be identified in the early stage of the drug development process, to achieve better control of manufacturing (CMC) in the later stages of compound development. However, those present only at low concentrations are often analyzed significantly later in the process. Finding the structure and source of an impurity is often instrumental in evolving a method for controlling it or eliminating it completely. Delays in conducting impurity analyses often occur because regulatory deadlines …
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An Interview With Antiva Biosciences
Antiva Biosciences develops creatively designed therapeutics that dramatically improve health outcomes for patients suffering from diseases caused by HPV. Averica Discovery worked with Antiva to provide specialist contract research services. Here we sit down with Mike Wallace, Director, Pharm Dev and CMC Project Mgmt at Antiva Biosciences to discuss his experience of working with us. MW: We worked with Averica to force degrade an API. The scope of work included analytical method development, force degradation and tentative structural assignments based …
Developing and Validating an HPLC Method
A host of resources must be harnessed to bring a drug to commercial launch. These include in-house development scientists, CROs and CMOs, all of whom are dependent upon reliable and reproducible data. This inevitably requires methods which generate high-quality results. Method development is a core capability at Averica. Our methods are robust, can be performed in-house by the client through the use of transferable technology, produce consistent results, and are aimed at deadline-oriented drug development processes. Averica employs a unique …
Averica Discovery Announces New Leadership Team and Expands into A Larger Facility
Averica Discovery Services Inc., announced today a new leadership team and the expansion into a larger facility to meet rising industry demand. Paul Lefebvre has been promoted to General Manager of the company to work alongside Cindy Berger, Vice President of Operations. In addition, Heather Lane has been appointed to lead sales and marketing activities. Paul has led Averica’s growing laboratory since January 2008 when he joined from Waters. Heather brings over 19 years of business and sales experience in …
Understanding the importance of stress degradation studies
“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 …
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 …