Analytical Testing / Services

Analytical Testing

SAFC® offers specialized testing services to support both pharmaceutical and biopharmaceutical development. We offer programs for:

API method development

Analytical validation and verification

Spent medium analysis

Solid state analytical testing

Pharmaceutical raw material analysis

Test results can be used to support development projects, regulatory filings, or batch release. Data can be supplied in customized formats along with expert comments and recommendations.

API Testing Capabilties

HPLC, gas and ion chromatography, identification, water analysis, autotitrators, UV spectrometry, melting point range, tapped density, particle size determination

Spent Medium Analysis

Free amino acids, lipids/fatty acids, water-soluble vitamins, standard elements, trace elements, cholesterol, glucose

Pharmorphix Solid State

Diffraction studies, structure elucidation, thermal methods, moisture sorption, bulk properties determination, microscopy

Pharmaceutical Raw Materials

EDXRF, Maldi-TOF, multinuclear FTNMR, ICPMS, LCMS, GC-MS/MS

Services

SAFC offers specialized development and manufacturing services to assist throughout the biopharmaceutical development process. From developing an optimal expression platform to designing a custom single-use bioprocessing solution, we can assist you in each stage of biopharmaceutical development:

Cell engineering

Media screening

Media optimization and simplification

Media and feed development

Custom small-scale medium manufacturing

Biomanufacturing scale-up solutions

Spent medium analysis and stability testing

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