Our Services

Comprehensive analytical support for all phases of drug development from discovery through commercialization.

Key Features

IND (Investigational New Drug) application support

• NDA (New Drug Application) analytical packages

• ANDA (Abbreviated New Drug Application) support

• Discovery and preclinical analytical support

• Phase I-III clinical trial support

• CMC (Chemistry, Manufacturing, Controls) documentation

• Regulatory submission packages

• Post-market surveillance testing

Applications

• Small molecule drug development

• Biologic drug development

• Biosimilar development

• Generic drug development

• Combination products

• Medical device-drug combinations

Comprehensive protein characterization services for monoclonal antibodies, biosimilars, and complex biologics.

Key Features

• Intact mass analysis (native and denatured conditions)

• Peptide mapping and sequence confirmation

• Glycan analysis (N-linked and O-linked)

• Charge variant analysis by cIEF and IEX

• Size variant analysis by SEC-HPLC

• Aggregation and fragmentation studies

• Post-translational modification analysis

• Disulfide bond mapping

• Higher order structure analysis (CD, FTIR, DSC)

• Forced degradation studies

Applications

• Monoclonal antibody (mAb) characterization

• Biosimilar comparability studies

• Antigen characterization

• Therapeutic protein development

• Vaccine characterization

• Cell and gene therapy products

Comprehensive safety testing and quality control for biopharmaceutical products.

Key Features

• Sterility testing (USP <71>)

• Bacterial endotoxin testing (USP <85>)

• Mycoplasma testing (USP <63>)

• Bioburden testing

• Container closure integrity testing

• Particulate matter testing

• pH and osmolality testing

• Residual DNA testing

• Host cell protein (HCP) quantification

• Residual solvent analysis

Applications

• Biopharmaceutical release testing

• Raw material qualification

• Environmental monitoring

• Process validation support

• Stability testing programs

• Regulatory compliance testing

State-of-the-art mass spectrometry platforms for comprehensive molecular analysis.

Key Features

• LC-MS/MS (Liquid Chromatography-Mass Spectrometry)

• GC-MS/MS (Gas Chromatography-Mass Spectrometry)

• ICP-MS (Inductively Coupled Plasma-Mass Spectrometry)

• Orbitrap Elite and Exploris 240 systems

• High-resolution accurate mass detection

• Proteomics and metabolomics analysis

• Trace-level detection capabilities

Applications

• Pharmaceutical analysis and drug development

• Environmental monitoring and contaminant detection

• Food safety and residue analysis

• Biomarker discovery and validation

Comprehensive analysis of solid-state properties for pharmaceutical development.

Key Features

• X-Ray Powder Diffraction (XRPD)

• Differential Scanning Calorimetry (DSC)

• Thermogravimetric Analysis (TGA)

• Polymorphic screening and characterization

• Salt and cocrystal screening

• Stability studies

• Crystal structure analysis

Applications

• Drug substance characterization

• Formulation development support

• Quality control testing

• Regulatory submissions

Advanced chromatographic techniques for pharmaceutical and environmental analysis.

Key Features

• High-Performance Liquid Chromatography (HPLC)

• Gas Chromatography (GC)

• Ultra-High-Performance Liquid Chromatography (UHPLC)

• Ion chromatography

• Preparative chromatography

• Method development and validation

• Automated sample preparation

Applications

• Pharmaceutical purity testing

• Environmental contaminant analysis

• Food and beverage analysis

• Process monitoring and optimization

Comprehensive elemental analysis using advanced spectroscopic techniques.

Key Features

• ICP-OES (Inductively Coupled Plasma-Optical Emission)

• ICP-MS (Inductively Coupled Plasma-Mass Spectrometry)

• Atomic Absorption Spectroscopy (AAS)

• X-ray Fluorescence (XRF)

• Heavy metals and trace elements

• Multi-element simultaneous analysis

• ppb to ppt detection limits

Applications

• Environmental compliance testing

• Food safety and nutrition analysis

• Pharmaceutical elemental impurities

• Materials characterization

Advanced analytical techniques for impurity profiling and metabolite identification.

Key Features

• Impurity profiling and quantification

• Forced degradation studies

• Residual solvent analysis

• Elemental impurity testing

• Genotoxic impurity analysis

• Method development for trace analysis

• Metabolite identification and characterization

Applications

• Drug substance and product testing

• Stability studies

• Process development support

• Regulatory compliance

Comprehensive testing services for environmental and food safety applications.

Key Features

• Pesticide residue analysis

• Heavy metals testing

• Water quality analysis

• Soil contamination assessment

• Food safety testing

• Environmental monitoring

• Mycotoxin analysis

Applications

• Food and beverage testing

• Environmental compliance

• Agricultural products

• Regulatory submissions

Key Features

• Recombinant protein expression (E. coli, mammalian, yeast, insect)

• Monoclonal antibody (mAb) production and purification

• Biosimilar protein production and characterization

• Antigen expression and purification for vaccine development

• Protein A/G affinity chromatography

• Ion exchange and hydrophobic interaction chromatography

• Size exclusion chromatography and polishing

• Endotoxin removal and bioburden reduction

• Scale-up from μg to 100s mg quantities

• Custom protein modifications and conjugations

Applications

• Therapeutic mAb production

• Biosimilar development and manufacturing

• Vaccine antigen production

• Research-grade protein preparation

• Protein-drug conjugate (PDC) development

• Immunoassay standard preparation

Comprehensive formulation development services for small molecules and biologics from preformulation to commercial scale.

Key Features

• Preformulation studies and API characterization

• Excipient compatibility testing

• Dissolution testing and method development

• Stability-indicating method development

• Forced degradation studies

• Formulation optimization and scale-up

• Content uniformity and blend uniformity testing

• Particle size analysis and characterization

• Biologic formulation development (mAbs, proteins)

• Lyophilization cycle development and optimization

Applications

• Oral solid dosage form development

• Injectable formulation development

• Topical and transdermal formulations

• Biologic drug product development

• Biosimilar formulation comparability

• Stability testing and shelf-life determination

• Bioavailability and bioequivalence support

• Regulatory filing support (IND, NDA, ANDA)