We had to turn to Alera Labs when our former CRO ran into major difficulties with drug product stability assessment. Alera Labs was able to develop and validate a challenging analytical method within an extremely short timeframe. This helped us start our clinical program on time.
Alera Labs is a contract research organization (CRO) providing analytical and pre-formulation support to pharmaceutical, biotech and medical device companies. Alera Labs also provides analytical support to agricultural companies. Alera Labs was founded in 2010 after realization that most larger CROs are not able to accommodate the needs of the small startup companies requiring faster response times and operating with much smaller budgets. It is extremely crucial for a small startup funded by angel or venture capital funds to achieve milestones on time, and even a day delay means a world of difference in the success of the process or formulation, or start of toxicology or clinical studies.
Our company specializes in providing high quality analytical services at a low cost with the fastest turnaround time in the industry at no additional charge. Its founders worked on both sides of the CRO business (as part of a CRO and at pharmaceutical or medical device companies) and know all the shortcomings of the majority of the CROs firsthand.
We are the only company that would provide you with a quotation within 24 hours of your work request.
Starting with a proposal for the work that you require and working with you closely to bring your project to successful closure, we will always ensure timely communication and the most efficient solutions to your problems.
We received a request through the website to perform an urgent investigation of a plant culture media to verify concentration of two carbohydrates and an antibiotic at a very low concentration. In addition, antibiotic did not have any UV absorbance, thus complicating its detection. Nevertheless, only two days later, a suitable LC-MS method was developed and successfully used to troubleshoot media preparation. Our client was able to uncover complex interactions between different media components and come up with a solution for a viable formulation.
One of our clients requested to develop a method for a very low abundance plant intermediate. Major obstacles were instability of this metabolite during sample preparation and its surfactant nature, which presented a significant challenge in its chromatographic separation. We were able not only successfully develop a very sensitive LC-MS/MS method, but also achieve much higher recoveries in our spiking experiments compared to the best values published previously (90% vs 15%).
One of our clients was developing an inhalation formulation containing two actives at extremely low concentration. One active was a lypopeptide with no chromophore, the other active was a phosphorothioate oligonucleotide with very unusual properties. The client turned to us after two other CROs failed to develop a viable assay, and thus critical animal studies were significantly delayed. We were able to develop suitable assays in a short timeframe and transfer the methods to the animal facility. Drug development program has since progressed to the clinical stage.
LTI was introduced to Alera Labs when a client sourced them for their project. Alera was very flexible in helping to meet the unique product’s needs. They had the speed and ability to run complex analyses without any OOS’s. We look forward to working with them again in the future endeavors.
Alera Labs has a great deal of experience with chemical analysis of the compounds in our market space. They have been very helpful in setting up and running HPLC assays suited to our specific needs with minimal investment. They also provide super fast turnaround times on our analyses and this has significantly reduced our development times since we started working with them a few years ago.