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 analytical testing laboratory providing analytical and pre-formulation support to pharmaceutical, biotech, medical device and agricultural (agbio) companies. Alera Labs was founded in 2010 after realization that most larger contract laboratories 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.
We have provided quotation on the day of an inquiry and started the work the very next day on multiple occasions. We have also developed assays within one week and analyzed samples for a low as $10/sample in a high throughput fashion.
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.
Alera Labs offers comprehensive impurities testing for both small and large molecule drug products or APIs. We can perform forced degradation studies, which will provide an insight into potential degradation pathways and their potential impact on pharmaceutical development. Degrading related impurities can be characterized or identified by performing degradation studies under acidic, basic, oxidative, and various heat and light conditions.
If you have a drug product or API that exhibits peaks in chromatograms that you would like to identify, we will assist with structure elucidation using LC-MS technique. Such studies are usually required during pre-clinical and early clinical stages. Major degradation products also need to be identified during forced degradation studies.
Your program will benefit tremendously from optimization of absorption, distribution, metabolism, excretion, and toxicity properties (ADME/Tox) of your compounds in addition to pharmacology (efficacy and selectivity).
We will also gladly perform fast and efficient sample analysis either using a method provided by the client or developed by us.
Fastest Non-GLP LC-MS/MS BioAnalysis
If you need to quickly obtain PK or TK data for your drug candidate, Alera labs will develop a “research grade” qualified bioassay using industry standard Sciex API-4000 LC-MS/MS instrument within one week (on average). We will then analyze your bioanalytical samples within 3-5 business days. Compare our average turnaround time to that of any larger CRO (1-3 months) and you will clearly see the difference. We partner with several local labs that provide toxicologic services.
Method and Assay Development
If you are in need of a challenging method development, you’ve come to the right place. Our scientists have expertise with virtually all possible classes of compounds and can find solutions to most difficult separations. Whether you are looking to quantitate a low level active compound with no UV chromophore or a highly labile compound, we can help solve your problem.
Biomarker Analysis and Assay
Ask us about validated, reliable biomarkers that can be used in your project. We can provide free analysis of markers appropriate for your pathway or set up quantitative assays for your marker of interest.
– Solution stability studies (define sensitivities to pH, buffer, buffer strength, and salt concentration)
– Solubility curves (determine ionization constant (pKa), define osolvent and complexing solubility)
– Agglomeration or micelle determination and size
– Forced degradation and compound/protein stabilization studies
– Determine compound or protein sensitivity to pH, heat or oxidation
– Stabilizer screening (using pharmaceutical, veterinary or agricultural approved additives)