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(919) 228-8209Alera Labs, LLC104 TW Alexander Dr., Building 3, Research Triangle Park, NC 27709
Alera Labs, LLCAlera Labs, LLC
Alera Labs, LLC
  • HOME
  • ABOUT US
    • Overview
    • Industries we serve
      • Chemical industry
      • Pharmaceutical industry
      • Cosmetic, Health and Beauty industries
      • Food industry
      • Dietary Supplements
    • Turnaround time
  • SERVICES
    • Discovery Services
      • Impurity Identification
      • Structure Elucidation
      • ADME/Tox Assay
      • Stability Testing
    • Development Services
      • Bioanalytical services
      • Method and Assay Development
        • Method Troubleshooting and Optimization
        • Method Development, Validation and Transfer
      • Biomarker Analysis and Assay
      • Preformulation Development
  • CAPABILITIES
    • Gas Chromatography
    • Liquid Chromatography
    • GC/MS
    • LC/MS
    • LC-MS/MS
    • ICP-MS
    • FTIR
    • Karl Fischer
  • RESOURCES
    • Brochures
    • Clients Speak
    • Gallery
    • Online payment
  • CONTACT US
  • CAREERS
  • BLOG
  • HOME
  • ABOUT US
    • Overview
    • Industries we serve
      • Chemical industry
      • Pharmaceutical industry
      • Cosmetic, Health and Beauty industries
      • Food industry
      • Dietary Supplements
    • Turnaround time
  • SERVICES
    • Discovery Services
      • Impurity Identification
      • Structure Elucidation
      • ADME/Tox Assay
      • Stability Testing
    • Development Services
      • Bioanalytical services
      • Method and Assay Development
        • Method Troubleshooting and Optimization
        • Method Development, Validation and Transfer
      • Biomarker Analysis and Assay
      • Preformulation Development
  • CAPABILITIES
    • Gas Chromatography
    • Liquid Chromatography
    • GC/MS
    • LC/MS
    • LC-MS/MS
    • ICP-MS
    • FTIR
    • Karl Fischer
  • RESOURCES
    • Brochures
    • Clients Speak
    • Gallery
    • Online payment
  • CONTACT US
  • CAREERS
  • BLOG
  • WHY CHOOSE
    ALERA LABS
    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 more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays
  • WHY CHOOSE
    ALERA LABS
    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.
    Read more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays
  • WHY CHOOSE
    ALERA LABS
    METHOD TROUBLESHOOTING AND
    OPTIMIZATION
    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 more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays
  • WHY CHOOSE
    ALERA LABS
    SAMPLE ANALYSIS / INVESTIGATION
    We will also gladly perform fast and efficient
    sample analysis either using a method provided
    by the client or developed by us.
    Read more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays
  • WHY CHOOSE
    ALERA LABS
    BIOMARKER ANALYSIS AND ASSAY
    DEVELOPMENT SERVICES
    Analysis of biomarkers in biological samples
    can dramatically increase your chances of
    success in any drug development program
    Read more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays
  • WHY CHOOSE
    ALERA LABS
    PREFORMULATION SERVICES
    Our expert team will provide a variety of
    preformulation services to support your early
    stage drug development program.
    Read more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays
  • WHY CHOOSE
    ALERA LABS
    ADME / TOX ESSAYS
    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 more
    Method Development, Validation and Transfer
    Impurity Identification and Structure Elucidation
    Method Troubleshooting and Optimization
    Sample Analysis / Investigation
    Biomarker Analysis and Assay Development services
    Preformulation services
    ADME / Tox essays

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.

Case studies

  • Project 1
  • Project 2
  • Project 3

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.

+ Project 1

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.

+ Project 2

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%).

+ Project 3

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.

Testimonials

  • 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.

    Prof. Linmarie Sikich, University of North Carolina
  • 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.

    Carrie Shults, project manager from Lyophylization Technology, Inc.
  • 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.

    CEO of a pharmaceutical device testing company from the Boston area
Services Overview

Discovery Services

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    Impurity Identification

    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.

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    Structure Elucidation

    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.

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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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    Stability Testing

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

Development Services

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    Bioanalytical services

    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.

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    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.

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    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.

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    Preformulation Development

    – 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)

Our capabilities
Request a quote to get pricing and service information from Alera Labs
Contact info
  • Location:
    PO Box 13019 (USPS only) 104 TW Alexander Dr., Building 3, Research Triangle Park, NC 27709
  • Phone numbers:
    (919) 228-8209
  • E-mail:
    info@aleralabs.com
Blog
  • Cell death assays for drug discovery Part 3
    May 28, 2011
  • Cell death assays for drug discovery Part 2
    May 19, 2011
  • Cell death assays for drug discovery Part 1
    May 19, 2011
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