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

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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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Sunday, 20 May 2012

Welcome to Alera Labs

Alera Labs is a contract research organization (CRO) providing analytical and pre-formulation support to small and mid-size 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 out of much smaller budgets. It is extremely crucial for a small startup funded by a venture capital to achieve certain milestones on time, and even one day means a world of difference for the success of the process or formulation development program.

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 and medical device companies while having to outsource analytical work) 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, in most cases within the same day.

Starting with a proposal for the work that you require and working with you closely to bring your project to a successful closure, we will always ensure timely communication and find the most efficient solutions to your problems.

Recent advances and additions to our method portfolio include:

- Quantitative analysis of fatty acid composition and/or cholesterol in various matrices from as little as 1mg of sample

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

- Analysis of metabolic plant intermediates using LC-MS/MS at ppb levels (useful for monitoring of transgenic plant metabolic pathways)

 

Services Overview

Small Molecule Analysis

- Analytical development for testing of raw materials, intermediates 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, etc.
- Investigational studies involving structure elucidation of unknown degradation products/impurities requiring advanced techniques (e.g. LC-MS)
- Validation of analytical methods according to ICH guidelines
- Developmental stability studies
- Biomarker analysis and assay development services
- Extractables and Leachables testing

Large Molecule Analysis (Composition, MW, Assays)

- Protein and peptide characterization
- DNA and RNA oligonucleotide analysis
- Lipid analysis (fatty acid composition, cholesterol etc)
- Carbohydrate and polysaccharide analysis
- DNA and RNA oligonucleotide analysis
- Synthetic polymer analysis

Preformulation Studies

- Solution stability studies (define sensitivities to pH, buffer, buffer strength, and salt concentration)
- Solubility curves (determine ionization constant (pKa), define solvent and cosolvent solubility)
- Agglomeration or micelle determination and size
- Forced degradation and compound/protein stabilization studies
- determine compound/protein sensitivity to pH, heat or oxidation
- stabilizer screening (using pharmaceutical, veterinary or agricultural approved additives)

Aqueous or Cosolvent Product Development

- Prototype formulas developed based on preformulation study results
- Round 1: short term stability studies to separate the wheat from the chaff
- Round 2: optimize formulas and monitor on stability to pick the champion

Filter Compatibility Screening

-Screen compound/protein adsorption and stability following filtration at lab scale

ADME/Tox Services

Alera Labs also provides preclinical contract testing services for the evaluation and optimization of the ADME, Toxicity and Pharmacokinetic properties of drug candidates early in the drug-discovery process. Click here 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)
- GC-MSD (Gas Chromatography with Mass Selective Detection)
- Capillary Electrophoresis
- UV-Vis (Ultraviolet/Visible Spectroscopy)
- FTIR (Fourier Transformation Infrared Spectroscopy)