Alera Labs, LLC. - Contract Analytical Laboratory in RTP, NC Area


Why choose Alera Labs

  • Method Development, Valid…
  • Impurity Identification a…
  • Method Troubleshooting an…
  • Sample Analysis / Investi…
  • Biomarker analysis and as…
  • 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.

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Impurity 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.

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Method 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.

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Sample Analysis / Investigations

We will also gladly perform fast and efficient sample analysis either using a method provided by the client or developed by us.

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Biomarker analysis and assay development services

Analysis of biomarkers in biological samples can dramatically increase your chances of success in any drug development program

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Preformulation Services

Our expert team will provide a variety of preformulation services to support your early stage drug development program.

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ADME/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).

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Wednesday, 22 Feb 2017

Welcome to Alera Labs

Alera Labs is a contract research organization (CRO) providing analytical and pre-formulation support to pharmaceutical, biotech and medical device 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.

Recent advances and additions to our method portfolio include:

- Quantitative analysis of PEG load on gold nanoparticles down to several molecules per particle

- Quantitative analysis of fatty acids, fatty alcohols/aldehydes, leukotrienes and cholesterol in various matrices from as little as 2 mg of sample

- Extremely sensitive in vitro method for determination of DNA crosslinks using LC-MS, which can be used for screening or optimization of anti-cancer drugs with DNA crosslinking mode of action

- Analysis of metabolic plant intermediates using LC-MS/MS at ppb levels, which is useful in monitoring transgenic plant metabolic pathways

- High throughput HPLC assay for quantitative carotenoid testing from as low as 20mg of plant tissue

Services Overview


Small Molecule Analysis

- Analytical development for testing of raw materials, intermediates, drug substances and finished products (various dosage forms)

- Development of analytical methods for the analysis of compounds requiring advanced levels of difficulty, e.g. absence of UV-Vis chromophores,  extensive matrix interference, poor peak resolution etc

- Investigational studies involving structure elucidation of unknown degradation products or impurities requiring advanced techniques (e.g. LC-MS)

- Validation of analytical methods according to ICH guidelines

- Bioassay development and sample analysis using LC-MS/MS (ABI Sciex API-4000)

- Developmental stability studies

- Biomarker analysis and assay development services


Large Molecule Analysis (MW, Composition, Assays)

- Protein and peptide characterization using HPLC-MALS (multiangle laser light scattering)

- Protein separation and purification by FPLC (analytical and semi-preparative)

- DNA and RNA oligonucleotide analysis

- Lipid analysis (fatty acid composition, cholesterol etc)

- Carbohydrate and polysaccharide analysis

- DNA and RNA oligonucleotide analysis

- Synthetic polymer analysis


Extractables and Leachables Testing

Preformulation Studies (click to learn more)

ADME/Tox Services (click to learn more)

Some examples of analytical techniques used

- HPLC-DAD (High Performance Liquid Chromatography with Diode Array Detection)

- HPLC-FLD (Fluorescence Detection)

- HPLC-RI (Refractive Index Detection)

- HPLC-ELSD (Evaporative Light Scattering Detection)

- HPLC-Ion Chromatography

- HPLC-GPC (Gel Permeation Chromatography)

- HPLC-MSD (Mass Selective Detection)

- HPLC-MS/MS (Tandem Mass Spectrometry)

- GC-MSD (Gas Chromatography with Mass Selective Detection)

- Capillary Electrophoresis

- UV-Vis (Ultraviolet/Visible Spectroscopy)

- FTIR (Fourier Transformation Infrared Spectroscopy)

- NMR (1H, 13C) - Nuclear Magnetic Resonance

- ICP-MS (Inductively Coupled Plasma - Mass Spectrometry)

- Protein separation and purification by FPLC (analytical and semi-preparative)






















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