Laboratory Services

Analytical Method Development
Biologics
Formulation Development
Laboratory Services

Comprehensive Laboratory Services for Pharmaceuticals and Biologics

Our advanced laboratories and experienced scientists specialize in method development, validation, and testing. These services ensure product quality, compliance, and informed decision-making from early development to commercialization, supporting clients in delivering safe and effective products to market.

Laboratory Services Core Capabilities

Small and large molecule development

Compendial testing: Chemistry and microbiology

Method establishment and QC testing

Stability testing and storage

  • Formulation Development

    We take a proven and proactive approach to guiding your drug product development program from compound to clinic.

    Our team specializes in addressing challenging formulations for New Chemical Entities (NCEs) and crafting high-performance dose forms that align with your specific needs.

    Services

    • Early-phase accelerated programs
    • Versatility across biopharmaceutical classification systems
    • Creative solutions for pharmaceutical challenges
    • Expertise in parenteral and solid formulations

  • Analytical Method Development

    We can help elevate your pharmaceutical development by ensuring regulatory compliance. Our adaptable analytical services can support from pre-clinical stages through to commercialization and post-launch analyses.

    Our cGMP analytical laboratories are designed to maximize efficiency, meet your development needs, and deliver results. We use an Electronic Laboratory Notebook (ELN), enabling direct integration with formulation development, project management, and quality systems.

    Services

  • Biologics Laboratory Services

    Alcami provides extensive analytical services for biologics, including peptides, proteins, and oligonucleotides. We support drug development from initial characterization to commercial release, focusing on safety, purity, and efficacy. Alcami utilizes a range of advanced analytical techniques and instrumentation to assess binding, identification, characterization, purity, and safety attributes of biologics.

Modalities Supported

  • Peptides
  • Proteins
  • Oligonucleotides
  • Plasmids and vaccines

Development Service Offerings

  • Cell & Gene Therapy Laboratory Services

Modalities Supported

  • Viral vectors
  • Autologous
  • Allogeneic

Development Service Offerings

Related Topics
Biologics
Navigating the Next Phase of Biologics
Host Cell Impurities, Bioassays, Micro-Flow Imaging
Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential
Contact Alcami
Summary

Alcami offers comprehensive laboratory services for pharmaceutical and biotechnology companies, including standalone and bundled options with drug product manufacturing. With decades of experience, we provide analytical testing, formulation development, and method establishment. Our expertise spans small and large molecules, including biologics, peptides, and advanced therapies. Our services support drug development from early stages to commercialization.

Related Topics
Biologics
Navigating the Next Phase of Biologics
Host Cell Impurities, Bioassays, Micro-Flow Imaging
Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential
Contact Alcami
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