Averica Discovery Services

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:
- Structure Elucidation
- Reference Standards
- Toxicology Studies

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

Product Testing Services