Integral BioSystems


Contract research organization (founded 2009, operational 2011) providing R&D and cGLP technical services for specialty drug formulation development. Core activities include formulation development across multiple delivery routes, analytical method development and transfer, scale-up/process engineering and licensing of platform delivery technologies. Facility is a ~10,000 sq ft laboratory with a documented quality system supporting R&D and cGLP activities.

Industries

biotechnology

Nr. of Employees

small (1-50)

Integral BioSystems

Integral BioSystems, LLC 23 Crosby Dr Ste 100A Bedford, MA 01730


Patents

Membrane-adherent self-assembled systems for treatment of ocular disorders

US-10603273-B2

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Methods and biocompatible compositions to achieve sustained drug release in the eye

US-10328033-B2

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Methods and biocompatible compositions to achieve sustained drug release in the eye

US-9931306-B2

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Membrane-adherent self-assembled system for treatment of ocular disorders

US-9901544-B2

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Products

Lipid nanoparticle delivery platform for enhanced bioavailability

Platform lipid nanoparticle technology designed to transport molecules across biological membranes (e.g., cornea, mucosa) to improve tissue absorption and reduce required dose.

Thin-film wafer platform for mucosal/ocular sustained delivery

Dissolvable or non-dissolvable thin-film wafer technology for sustained local delivery to mucosal surfaces; can function as a biomimetic bandage and deliver labile molecules while maintaining molecular integrity.


Services

End-to-end formulation development for a range of dosage forms and routes up to preclinical readiness.

HPLC/UPLC method development and transfer, LC-MS/MS assays, stability studies, impurity mapping and bioanalysis in tissue matrices.

Preparation, analytical release and stability testing of toxicology supplies under cGLP oversight.

Scale-up using process equipment and development of process controls; technology transfer to cGMP manufacturers.

Fee-for-service collaborations and evaluation/licensing of delivery platforms to enhance API performance or enable IP strategies.

Expertise Areas

  • Ophthalmic drug delivery
  • Formulation development for multiple administration routes
  • Sustained-release and controlled-release systems
  • Analytical method development and bioanalysis
  • Show More (6)

Key Technologies

  • Lipid nanoparticles (LNP)
  • Thin-film dissolvable wafer delivery
  • Microencapsulation / microspheres
  • Nano- and micro-crystallization
  • Show More (9)

News & Updates

Participation and presentations at scientific conferences including ARVO and TechConnect, showcasing ocular delivery platforms and related technologies.

Monthly newsletter for collaborators tracking patent grants, trademarks, collaborations and conference updates.

Company technologies (platform delivery systems) have received patent grants and validations in multiple global jurisdictions as reported in press releases.

Established a subsidiary focused on productizing delivery platforms and pipeline development (announced in news and event posts).


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