Method Troubleshooting and OptimizationIf you have an old QC method that does not work and constantly needs troubleshooting, we might have a solution for you. In the past, we have identified shortcomings in our clientele's various existing methods and assisted them with improving their methods’ performance. We have also helped them define and perform additional validation experiments to maintain compliance. Sample Analysis / InvestigationsWe can perform fast and efficient sample analysis either using a method provided by the client or developed by us. We strive to provide the fastest turnaround time possible because we know that every day makes a big difference in a fast paced drug development environment. Oftentimes, urgent investigations need to be performed that impact manufacturing process and effect drug quality and we do our best to accommodate such urgent requests. Identification and Structure ElucidationIf 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. Method Development, Validation and TransferIf 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. Once we develop a method, we can assist with method validation and transfer to a third party or to the client’s laboratory. We will provide necessary guidance on the validation experiments required in compliance with cGMP. |
Preformulation Studies- Solution stability studies (define sensitivities to pH, buffer, buffer strength, and salt concentration) Solution Product Development - Prototype formulas developed based on preformulation study results Filter Compatibility Screening- Screen compound or protein adsorption and stability following filtration at lab scale Biomarker analysis and assay development servicesWe can provide free analysis of markers appropriate for your pathway or set up quantitative assays for your marker of interest. Read more...
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Alera Labs, LLC. - Contract Analytical Laboratory in RTP, NC Area
Why choose Alera Labs
- Method Development, Vali…
- Impurity Identification …
- Method Troubleshooting a…
- Sample Analysis / Invest…
- Biomarker analysis and a…
- Preformulation Services
- ADME/Tox assays
Method Development, Validation and Transfer
Our scientists have expertise with virtually all possible classes of compounds and can find solutions to most difficult separations.
Read moreImpurity Identification and Structure Elucidation
If you have a drug product or API that exhibits peaks in chromatograms that you would like to identify, we can assist with structure elucidation using LC-MS technique.
Read moreMethod Troubleshooting and Optimization
If you have an old QC method that does not work and constantly needs troubleshooting, we might have a solution for you.
Read moreSample Analysis / Investigations
We will also gladly perform fast and efficient sample analysis either using a method provided by the client or developed by us.
Read moreBiomarker analysis and assay development services
Analysis of biomarkers in biological samples can dramatically increase your chances of success in any drug development program
Read morePreformulation Services
Our expert team will provide a variety of preformulation services to support your early stage drug development program.
Read moreADME/Tox assays
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).
Read moreOur Services
