PHARMACEUTICAL

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. Primera understands the unique needs of our customers and our extensive experience allows us to provide highest quality and fast turnaround times. We are registered with the FDA with no observations and no 483 findings from two FDA audits at October 2008 and April 2012. We are in full compliance with GLP/cGMP regulations.
  • Stability Studies
  • Leachables and Extractables
  • Chiral Separation
  • Drug Substance Impurity Profiles
  • Pre-clinical and Clinical Studies
  • Coulometric and Volumetric Karl Fischer Testing
  • Heavy Metal Analysis by ICP/MS
  • Polymer Analysis
  • Full Sample Management Service
  • Residual Solvents
  • Raw Materials Testing
  • Cleaning Validation

BIOANALYTICAL

Primera’s bioanalytical department provides exceptional services in method feasibility, development, validation, method transfer and sample analysis with strong scientific background, up-to-date regulatory knowledge, extensive industry experience and cutting edge instrumentation. Our highly skilled scientists have a proven record working with the most challenging compounds and complicated biological matrices with fast turnaround time under both GLP and non-GLP environments. Our mission is to provide high quality product, fast turn-around at a competitive price. Exceeding your expectations is always our goal.
  • Method Feasibility and Method Development
  • GLP Method Validation
  • GLP Sample Analysis in support of clinical trials
  • Bioequivalence Studies
  • Non-GLP DMPK Support
  • Controlled Substance License
  • Complex Sample Matrices Handling
  • Metabolism Stability CYP
  • CYP 450 Isozyme Mapping
  • CYP 450 Isozyme Induction and Inhibition
  • Blood, Serum, Urine, and Tissues

BIOPHARMACEUTICAL

We deliver high quality biopharmaceutical analysis services including biological assays and biochemical characterizations. Our team offers unsurpassed skill and experience in developing and optimizing biopharmaceutical analysis, method validation, sample analysis and stability storage services.
  • Biochemical Characterization of Protein and DNA
    • Molecular weight determination
    • pI determination
    • Amino acid composition analysis
    • Peptide mapping with HPLC or LC/MS/MS
    • Glycosylation assay (glycans, sialic acid, mono-saccharide)
    • Stability studies following ICH Guidelines
  • Impurity Analysis
    • Impurity ELISA assays: HCP, rPA, Customized impurities
    • Residual DNA by Q-PCR
  • Bioassay and immunoassay development, validation, and sample analysis
    • Ligand-binding assays
    • Immunogenicity assays
    • Anti-drug antibody assay
    • Neutralizing antibody assay
    • PK/TK assay
  • Cell-based assays (bioassays)
    • Antibody-dependent cell-mediated cytotoxicity (ADCC)
    • Complement dependent cytotoxicity (CDC)
    • Kinase domain receptor activation assay (KIRA assay)
    • GPCR assay
    • Cell proliferation and apoptosis
    • Customized cell based assays

AGROCHEM

We are experts in developing residue analytical method in complex matrices as well as accurate, fast turnaround residue analytical services. Our scientists have extensive experience in sample extraction and cleanups in soil, plant material and animal tissues. Primera uses internally developed or Sponsor-provided protocols to conduct Independent Laboratory Validations (ILVs) in accordance with the EPA Guidelines (PR Notice 96-1). Our scientists possess in-depth knowledge, extensive experience, and expertise in conducting and troubleshooting ILVs. Should the method provided fail to perform, Primera will prescribe remedial changes to the method for a subsequent successful ILV. Primera Analytical has refrigerators and freezers for a temperature range of 4°C to -80°C. We also have stability chambers that control temperature and moisture. All storage units are alarmed 24/7 and have independent generator backup.
  • Method Development
  • Independent Laboratory Validations (ILVs)
  • Storage Stability
  • Sample Analysis
    • Residue Studies
    • Soil Dissipation Studies
    • Ground and Surface Water Studies
Contact Us

We're not around right now. But you can send us an email and we'll get back to you, asap.