Primera Analytical Solutions is a GLP and GMP CRO in great standing with the FDA. Our primary objectives are quality and to become a trusted partner. 

Services include:

- Large and small molecule CMC, bioanalytical, release testing. Method development/validation, method transfer (Assay, Impurities, Dissolution, PK/PD, ADA, cell-based/non cell-based NAb)
- Cell & Gene Therapy (FACS, qPCR, ddPCR, cell-based assays
- Cell potency assays
- Impurity studies (LC/MS/MS, GC/MS, ICP/MS)
- Extractable and leachable studies
- Stability studies
- Dissolution
- Abuse-deterrent studies
- Solid state characterization
- Product and raw material release testing
- Metabolite characterization, bioavailability and bioequivalence studies
- Bioassay method development and validation
- Impurities by ELISA
- Peptide mapping
- HRMS

Analytics

Biotechnology

Clinical Trials

Health Care

Health Diagnostics

Life Sciences

Primera Analytical Solutions Corporation

Bibo Xu

Charles Stewart

Bianca Buckwalter

Ingrid Wang

Honghao L.

The Scientific Research Team at Primera Analytical Solutions is dedicated to advancing drug development through comprehensive analytical services. Leveraging expertise in method development, validation, and transfer, the team conducts a wide array of studies, including potency assays, impurity characterization, and stability testing. They ensure compliance with GLP and GMP standards, aiming to provide high-quality data that supports regulatory submissions and helps foster valuable partnerships with clients.

Scientific Research Team

Leadership Team

Quality Assurance

Scientific Research Team

About

Team members

Other teams at Primera Analytical Solutions Corporation

Leadership Team

Quality Assurance