Laboratory Services

Analytical Method Development

Analytical Method Development
Laboratory Services

Analytical method development tailored to your needs.

We offer a fully integrated analytical method development, validation, and testing solution, supported by advanced analytical and information technologies. From our electronic laboratory notebook (ELN) data collection system to its integration with formulation development, project management, and quality systems, our cGMP analytical laboratories are designed to maximize efficiency and deliver accurate results.

  • Formal Method Establishment Capabilities

    Method evaluation

  • Method development

  • Method transfer and verification

  • Phase-appropriate method validation

Full-Time Equivalent (FTE) Employee Programs

We offer full-time employees to provide dedicated support to your projects. Our FTE employees have full use of our services, equipment, and support to deliver on your program.

Analytical method development core capabilities

Drug substance and drug product stability indicating assays

Related substances, chiral purity, and residual solvent analysis

Dissolution testing with UV and HPLC backend

Preservative and stabilizing excipients assays

Phospholipid and fatty acid analysis

Physical and structural chemistry

Remedial method validation/method lifecycle evaluation studies

Drug substance and reference standard material characterization

Reference standard qualification

Process validation support

Cleaning method verification

Drug product comparator studies

Material contact studies

  • Biologics Analytical Method Development

    From the initial characterization of a drug substance to its commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality. With these critical attributes in mind, Alcami’s biologics analytical method development team will work with you to design a robust quality system to support every phase of your product development lifecycle.

    Binding | Potency

    Enzyme Activity, ELISA, Cell-Based Assay, UV Protein Concentration

  • Identification

    Western Blot, SDS-PAGE, Sequencing by LC / MS, Accurate Mass, Unknown Peak ID

  • Characterization

    Peptide Map, AAA, Oligosaccharide Analysis, Glycosylation Profile, Extinction Coefficient, Gel Permeability

  • Purity

    Chromatogprahic – RP-HPLC, IEX-HPLC, SEC Electrophoretic – SDS-PAGE, CE-SDS, IEF, cIEF

  • Safety

    Residual Host Cell Protein, Endotoxin (LAL), Bioburden, Sterility, Sub-visible Particulates (HISafety Residual Host Cell Protein, Endotoxin (LAL), Bioburden, Sterility, Sub-visible Particulates (HIAC and MFI)

  • Instrumentation

    Waters Q-tof Premier, Agilent 6550 Q-tof, AB Sciex API 4000 / 5000, Agilent GC / MS, Beckman PA800 CE-LIF, iCE Capillary IEF

Summary

Alcami offers a robust range of analytical services to support drug development. Our state-of-the-art laboratories provide a wide range of testing capabilities, including stability studies, impurity analysis, dissolution testing, and method development. With a focus on efficiency and data management, we deliver accurate and reliable results to meet client needs.

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