Testing biopharmproducts can be complicated and results can be unpredictable. For a good testing outcome, it is important to create a precise testing strategy that incorporates appropriate technology, relevant resolutions, in-depth data analysis, and results interpretation aligned with compliance standards and regulatory requirements.
At TechnoPharmaSphere, we help you devise specialized testing strategies and execute testing using state-of-the-art technologies. Through our business partners, we cover all the product’s characterization including chemical, physical, biophysical, and activity characteristics. We are capable of testing intermediate samples from process and final samples to drug substance, drug product, formulation & device, and samples from stability studies.
Our world-class pharmaceutical testing services are helping the biotech industry to introduce newer and effective biopharm products to the public, safe and cost-effective. We have a deep understanding of the international pharmaceutical sector, that’s why we offer profound analytical method development and sample testing services.
We offer a broad spectrum of testing services for protein-based, blood plasma protein, peptide, small molecules, exosome, DNA, RNA, cells, and gene therapy products, tests include but not limited to:
Product’s structure: MS, FTIR, CD, DSC, VCD, Raman, Raman Optical Activity (ROA), AUC, SEC-MALS, DLS, NMR, Fluorescence, UV-Vis.
Purity methods: SEC-HPLC, AFFFF, UPLC (SEC and RP), RP-HPLC, CEX, cIEF, AUC.
Subvisible particulates, viral particles, and cell analysis: FlowCAM, MFI, Archimedes, AUC, Flow cytometry, TEM, NTA, RMM.
Impurities: Process and product related impurities, leachable, extractable.
Nucleic Acid: PCR
Binding: SPR, ELISA, MSD
Drug Product: Pre-formulation development, formulation development, incidents investigation, stability samples, in-use clinical compatibility studies, osmolality, viscosity, solubility and precipitation measurement.
We are offering also testing services for small molecules which is sometimes necessary for biopharm product development such as in ADC. We offer testing services for small molecules and cannabinoid pharmaceutics formulations such as but not limited to:
RP-HPLC-UV, RP-UHPLC-UV, Gas chromatography (GC), Thin‐layer chromatography (TLC), Ultraviolet (UV) spectroscopy, Nuclear magnetic resonance (NMR) spectroscopy, Mass spectrometry, LC-MS & GC-MS, Particle Size Analysis, Titration, Loss on Drying (LOD, Loss on Ignition (LOI), Karl Fischer Titration, Disintegration, Dissolution, Uniformity of Dosage Units