Averica Discovery Services
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Marlborough, Massachusetts, US
Averica Discovery is an analytical development CRO, offering chromatography based custom services. Our expert chromatographers develop methods for the purification and analysis of small molecules to support drug discovery and development teams.
Our custom services involve the development and optimization of a chromatographic method specific to the project purpose. Services Include: chiral separation, achiral separation, small molecule purification, impurity isolation and identification, method development and validation, and custom assay development.
MEDICINAL CHEMISTRY SERVICES: Drug Target Assays, Drug Discovery Support Services, Compound Purification, Impurity Separation, Impurity Isolation, Impurity Identification, Medicinal Chemistry
ANALYTICAL LABORATORY SERVICES: Chromatography Separation, Chromatography Services, Chiral Resolution, Chiral Chromatography, Impurity Profiling, Discovery Analytical Services, Drug Preformulation Characterization Studies, Analytical Methods Development
NOTE: Averica is not an analytical testing lab, and doesn't not use chromatography systems for testing. Averica cannot handle any type of biologic fluid or material, such as serum or urine.
Preparative chromatography is a great solution for a source of purified enantiomer supply of small molecule chiral compounds, during the early and intermediate state of lead drug candidate profiling. We create method that are fast and easy to scale-up, giving you the ability to receive more material as needs change from milligrams to kilograms.
Preparative chromatography also offers a reliable and cost-effective purification solution. Whether polishing a batch of compound to achieve a hard-to-meet purity standard, producing reference standard material, removing a problematic impurity, or isolating an unknown degradant; we apply the same highly efficient preparative SFC and HPLC technology to solve the problem.
APPLICATIONS
-Purified supply material for mechanistic studies, differential activity, structural biology, in vivo toxicology, or advanced profiling
-Purification of water sensitive, unstable, or difficult to purify compounds
-Purification of compounds with multiple chiral centers
-Targeted purification of a desired enantiomer or isomer.
-“Polishing” compounds to achieve needed enantiomeric excess (ee)
INSTRUMENTATION
Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE
-Fastest turnaround & highest recovery
-Turnaround in DAYS, not weeks or months - even at larger scale
-DEA Schedule I-V compounds
-Success-oriented and highly responsive team with many years of pharmaceutical experience
Small molecule impurity isolation and identification offers you critical information on the structure of your impurity.
Preparative Scale Impurity Isolation Applications:
Averica’s process uses a broad suite of analytical and preparative instrumentation to rapidly develop a unique isolation strategy for each impurity. Our aim of giving you enough material to get a definitive structure, while creating a scalable method that can deliver material for reference standards or toxicology studies.
INSTRUMENTATION
Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE
-Trace component isolation 0.01% of bulk
-Batch scale chromatography to 1 kg
-Degradation kinetic studies — Understand Formation, Purge and Fate
-Drug substance or drug product — Solid, liquid, and semi-solid dosage forms
-Impurity method development and optimization
-Fast timelines, as short a week!
Averica offers rugged and robust analytical method development, method qualification, and method validation services specific to your small molecule drug development needs. Our approach considers the requirements of your compound together with the requirements of your method. With a properly developed method – fit to the compound and fit for purpose – your decision making will be easier, and your timeline will be shorter.
METHOD DEVELOPMENT SERVICES:
• Purity, potency (assay), and quantify impurities
• Stability indicating methods
• Chiral purity and chiral release testing
• ICH Q11 support, e.g. for qualification of regulated starting materials (RSMs)
• Molecules with unique complexity or physical properties
• Robust methods for fast method transfer
METHOD DEVELOPMENT ATTRIBUTES
System Suitability, Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ), Linearity, Accuracy, Sample Stability, Standard Stability, Evaluation of Range, Mass Balance, Physical properties assays, EPSA – Intramolecular Hydrogen Bonding
INSTRUMENTATION
Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE
-Emphasis on making sure that a chromatographic method meets your needs, and serves you development effort
-Depth of experience with method development makes us uniquely suited to tough compounds and projects
-Custom assay design and physical properties testing
-Small scale assay development for when material is limited
Preparative chromatography is a great solution for a source of purified enantiomer supply of small molecule chiral compounds, during the early and intermediate state of lead drug candidate profiling. We create method that are fast and easy to scale-up, giving you the ability to receive more material as needs change from milligrams to kilograms.
Preparative chromatography also offers a reliable and cost-effective purification solution. Whether polishing a batch of compound to achieve a hard-to-meet purity standard, producing reference standard material, removing a problematic impurity, or isolating an unknown degradant; we apply the same highly efficient preparative SFC and HPLC technology to solve the problem.
APPLICATIONS
-Purified supply material for mechanistic studies, differential activity, structural biology, in vivo toxicology, or advanced profiling
-Purification of water sensitive, unstable, or difficult to purify compounds
-Purification of compounds with multiple chiral centers
-Targeted purification of a desired enantiomer or isomer.
-“Polishing” compounds to achieve needed enantiomeric excess (ee)
INSTRUMENTATION
Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE
-Fastest turnaround & highest recovery
-Turnaround in DAYS, not weeks or months - even at larger scale
-DEA Schedule I-V compounds
-Success-oriented and highly responsive team with many years of pharmaceutical experience
Averica offers rugged and robust Mass Spec Services. We can import your method or engage in analytical method development specific to your small molecule drug development needs. Our approach considers the requirements of your compound together with the requirements of your method. With a properly developed method – fit to the compound and fit for purpose – your decision making will be easier, and your timeline will be shorter.
INSTRUMENTATION Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
METHOD DEVELOPMENT SERVICES: • Purity, potency (assay), and quantify impurities • Stability indicating methods • Chiral purity and chiral release testing • ICH Q11 support, e.g. for qualification of regulated starting materials (RSMs) • Molecules with unique complexity or physical properties • Robust methods for fast method transfer
METHOD DEVELOPMENT ATTRIBUTES System Suitability, Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ), Linearity, Accuracy, Sample Stability, Standard Stability, Evaluation of Range, Mass Balance, Physical properties assays, EPSA – Intramolecular Hydrogen Bonding
AVERICA ADVANTAGE -Emphasis on making sure that a chromatographic method meets your needs, and serves you development effort -Depth of experience with method development makes us uniquely suited to tough compounds and projects -Custom assay design and physical properties testing -Small scale assay development for when material is limited
Stress testing is a fundamental requirement in all drug development programs. It provides evidence of the effect of environmental factors of the quality of a drug substance or product. You don’t want to wait to find out what will happen to your product when exposed to temperature, humidity, light etc.
Accelerated stress testing allows you to get answers faster.
APPLICATIONS -drug compound, API or drug substance study of the effects of light, humidity, temperature, acid, base and hydrolysis conditions.
INSTRUMENTATION Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE -Fastest turnaround & highest recovery -Turnaround in DAYS, not weeks or months - even at larger scale -DEA Schedule I-V compounds -Success-oriented and highly responsive team with many years of pharmaceutical experience
Forced degradation or stress testing is a fundamental requirement in all drug development programs. It provides evidence of the effect of environmental factors of the quality of a drug substance or product. You don’t want to wait to find out what will happen to your product when exposed to temperature, humidity, light etc.
Accelerated stress testing allows you to get answers faster.
APPLICATIONS -drug compound, API or drug substance study of the effects of light, humidity, temperature, acid, base and hydrolysis conditions.
INSTRUMENTATION Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE -Fastest turnaround & highest recovery -Turnaround in DAYS, not weeks or months - even at larger scale -DEA Schedule I-V compounds -Success-oriented and highly responsive team with many years of pharmaceutical experience
Preparative chromatography is a great solution for a source of purified enantiomer supply of small molecule chiral compounds, during the early and intermediate state of lead drug candidate profiling. We create method that are fast and easy to scale-up, giving you the ability to receive more material as needs change from milligrams to kilograms.
Preparative chromatography also offers a reliable and cost-effective purification solution. Whether polishing a batch of compound to achieve a hard-to-meet purity standard, producing reference standard material, removing a problematic impurity, or isolating an unknown degradant; we apply the same highly efficient preparative SFC and HPLC technology to solve the problem.
APPLICATIONS
-Purified supply material for mechanistic studies, differential activity, structural biology, in vivo toxicology, or advanced profiling
-Purification of water sensitive, unstable, or difficult to purify compounds
-Purification of compounds with multiple chiral centers
-Targeted purification of a desired enantiomer or isomer.
-“Polishing” compounds to achieve needed enantiomeric excess (ee)
INSTRUMENTATION
Analytical HPLC, Analytical SFC, Analytical Reverse Phase HPLC, Preparative HPLC, Preparative SFC, Preparative Reverse Phase HPLC, Supercritical Fluid Chromatography (SFC), UPC2, UPLC, GC/MS, ELSD, Mass Spec (MS), Accurate Mass MS, CAD Detection, PDA/UV, NMR
AVERICA ADVANTAGE
-Fastest turnaround & highest recovery
-Turnaround in DAYS, not weeks or months - even at larger scale
-DEA Schedule I-V compounds
-Success-oriented and highly responsive team with many years of pharmaceutical experience
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