Integral BioSystems, LLC
Integral BioSystems is a pharmaceutical contract research organization working on complex products such as long-acting injectables, suspensions, injectables and topical formulations for intranasal, dermal, ophthalmic, subQ and intramuscular routes. It provides preclinical formulation, analytical, testing, and process-development services for complex drug products, including small molecules, proteins, peptides, and nucleic acids. Its work spans route-specific dosage-form development, cGLP studies, stability and release testing, scale-up, and technology transfer. The company has an innovation-focused wholly owned subsidiary, Symphony Therapeutics, LLC, with licensable products (OcuHeal-UV400+, NanoM-Wafer Lubricating Bandage). Symphony is operating within Integral facilities.
Industries
Nr. of Employees
small (1-50)
Integral BioSystems, LLC
23 Crosby Drive, Suite 100A, Bedford, MA 01730
Integral BioSystems, LLC is currently seeking investment
Integral BioSystems, LLC is seeking a seed investment in the range of 1m-5m
Patents
Membrane-adherent self-assembled systems for treatment of ocular disorders
2020-03-31 • US-10603273-B2
View DetailsMethods and biocompatible compositions to achieve sustained drug release in the eye
2019-06-25 • US-10328033-B2
View DetailsMethods and biocompatible compositions to achieve sustained drug release in the eye
2018-04-03 • US-9931306-B2
View DetailsMembrane-adherent self-assembled system for treatment of ocular disorders
2018-02-27 • US-9901544-B2
View Details
Membrane-adherent self-assembled systems for treatment of ocular disorders
2020-03-31 • US-10603273-B2
View DetailsMethods and biocompatible compositions to achieve sustained drug release in the eye
2019-06-25 • US-10328033-B2
View DetailsMethods and biocompatible compositions to achieve sustained drug release in the eye
2018-04-03 • US-9931306-B2
View DetailsMembrane-adherent self-assembled system for treatment of ocular disorders
2018-02-27 • US-9901544-B2
View DetailsProducts
An ocular insert platform with formats designed for sustained delivery or for dissolution on the ocular surface. The inserts hydrate after placement, and composition can be adjusted to affect dissolution or release characteristics.
A lipid-based nanoscale delivery platform developed for ophthalmic formulations and evaluated for other routes, including dermal, otic, and intranasal delivery. The platform is described as carrying active ingredients in lipid cores within a dispersed formulation.
An ocular insert platform with formats designed for sustained delivery or for dissolution on the ocular surface. The inserts hydrate after placement, and composition can be adjusted to affect dissolution or release characteristics.
A lipid-based nanoscale delivery platform developed for ophthalmic formulations and evaluated for other routes, including dermal, otic, and intranasal delivery. The platform is described as carrying active ingredients in lipid cores within a dispersed formulation.
Services
Contract development of complex pharmaceutical formulations and dosage forms for small molecules, proteins, peptides, and nucleic acids across multiple administration routes.
Development strategy, formulation risk assessment, and project planning from molecule characterization and preformulation through development milestones.
Analytical method development, qualification, validation, and transfer; active ingredient and dosage-form characterization; bioanalysis; and stability, dissolution, release, and permeability testing.
Standalone testing engagements include reference-product deformulation, dissolution and in-vitro release testing, and tissue-permeability testing.
Preparation and testing of toxicology supplies, dose verification, release testing, and stability studies conducted under cGLP requirements.
Formulation process engineering, process-control development, scale-up, and transfer of development processes to cGMP manufacturing facilities.
Contract development of complex pharmaceutical formulations and dosage forms for small molecules, proteins, peptides, and nucleic acids across multiple administration routes.
Development strategy, formulation risk assessment, and project planning from molecule characterization and preformulation through development milestones.
Analytical method development, qualification, validation, and transfer; active ingredient and dosage-form characterization; bioanalysis; and stability, dissolution, release, and permeability testing.
Standalone testing engagements include reference-product deformulation, dissolution and in-vitro release testing, and tissue-permeability testing.
Preparation and testing of toxicology supplies, dose verification, release testing, and stability studies conducted under cGLP requirements.
Formulation process engineering, process-control development, scale-up, and transfer of development processes to cGMP manufacturing facilities.
Expertise Areas
- Pharmaceutical formulation development
- Ophthalmic drug delivery
- Injectable and depot formulations
- Controlled-release drug delivery
Key Technologies
- Lipid nanoparticles
- PLGA microspheres
- Cyclodextrin complexation
- Microencapsulation
Key People
Founder, President and CEO
Co-Founder, Chief Operations Officer, Legal Counsel and IP
Founder, President and CEO
Co-Founder, Chief Operations Officer, Legal Counsel and IP
News & Updates
A research summary describes microsphere development and testing, including particle size, peptide loading, burst release, accelerated release, and injectability.
A research summary describes a dissolvable ocular insert evaluated for surface spreading, dissolution time, mechanical properties, preclinical tolerability, and sterilization feasibility.
A research summary describes an ophthalmic lipid nanoparticle formulation evaluated for UV blocking, corneal-cell protection, ocular-tissue distribution, tolerability, and stability.
A research summary describes a lipid-based ophthalmic formulation evaluated for particle size, release, corneal permeability, and delivery of two active ingredients.
The company announced plans to exhibit at the annual meeting in Seattle, Washington, from May 5 to May 8, 2024.
A research summary describes microsphere development and testing, including particle size, peptide loading, burst release, accelerated release, and injectability.
A research summary describes a dissolvable ocular insert evaluated for surface spreading, dissolution time, mechanical properties, preclinical tolerability, and sterilization feasibility.
A research summary describes an ophthalmic lipid nanoparticle formulation evaluated for UV blocking, corneal-cell protection, ocular-tissue distribution, tolerability, and stability.
A research summary describes a lipid-based ophthalmic formulation evaluated for particle size, release, corneal permeability, and delivery of two active ingredients.
The company announced plans to exhibit at the annual meeting in Seattle, Washington, from May 5 to May 8, 2024.