Capability Statement

Integral BioSystems, LLC is a majority woman-owned business founded in 2009, with expertise and capabilities in drug development, specifically in R&D. Integral BioSystems is cGLP-compliant and is available to assist primary contractors and the NIH (and other appropriate government agencies) by providing the following services: 

SERVICES SUMMARY

  • Analytical method development (small molecules, biologics) by HPLC, UPLC
  • Analytical method qualification (cGLP)
  • API Characterization (XRPD, solubility, log P, forced degradation, NMR, FTIR, DSC, TGA, SEM)
  • Preformulation and compatibility studies
  • Formulation development
  • Nanocrystalline formulations
  • Emulsion, dispersion, liposomal formulations
  • Sustained Release Injectable Microspheres
  • Lipid Nanoparticles
  • Process Development and Scale up
  • Drug Binding studies
  • Container Closure studies
  • Syringeability studies
  • cGLP ICH Stability Studies
  • USP IV Flow-through IVRT studies
  • Particle Size Distribution (PSD), Laser Light Diffraction
  • Particle Sizing by Dynamic Light Scattering
  • Surface Tensiometry, Contact angle measurement
  • Osmometry
  • Moisture analysis by Karl Fisher
  • Rheology (Viscometry)
  • pH measurement
  • Residual Solvent Analysis by GC
  • Toxicology clean supplies and cGLP release testing
  • cGLP dose analysis
  • Bioanalytical method development
  • Analysis of API in tissues by bioanalytical LC/MS/MS
  • Scale-up and Technology Transfer

SUBJECT MATTER AND ROUTE EXPERTISE

  • Routes: Ophthalmic, Otic, Dermal, Sublingual
  • Analysis and formulation development of proteins, peptide, cDNA, protein-based vaccines for injectable and ophthalmic routes.
  • Analysis and formulation development of small molecules for injectable, intranasal, transdermal, pulmonary, otic and follicular formulations.
  • Subject matter expertise in sustained release delivery systems (microspheres, depot systems)
  • Subject matter expertise in eye-drops and ophthalmic drug delivery
  • Subject matter expertise in lipid nanoparticles and PLGA microspheres
  • Fast dissolving oral films to deliver vaccines

COMPETITIVE DIFFERENTIATION

  • Highly innovative and focused
  • Expertise is cutting-edge
  • Complex formulations
  • Trouble-shooting, problem solving various formulation issues

PAST PERFORMANCE AND CLIENTS

  • Have performed and delivered on >30 complex formulations in the injectable, ophthalmic and dermal space.
  • Assisted >20 companies in private sector with cutting-edge formulation development
  • Companies: Novartis, Alcon, Allergan, Perfuse, Allysta, Encore Vision, Nicox, ONO, ONL Therapeutics, Endogena, FHI360, Bill and Melinda Gates Foundation, Nacuity Pharmaceuticals.

COMPANY DATA

DUNS: 786575287; Cage code-6SVP3; NAICS CODE-541714

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