Laboratory Services

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

• Formal method establishment
• Compendial testing
• Specialty capabilities
• Full-Time Equivalent (FTE) programs

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.

Cell & Gene Therapy Laboratory Services