Integral Biosystems, LLC

About Integral Biosystems, LLC

Integral BioSystems, a contract research service organization in the Boston area specializes in the design and formulation development for ophthalmic, transdermal, intravenous, intranasal and oral routes of drug administration. Furthermore, the company offers intellectual property and contracts development/negotiation services. Integral BioSystems excels in the conceptualization and design of drug development solutions for drug candidates that are challenging to deliver. These challenges include inherent insolubility of the drug, intrinsic tissue impermeability of the drug, and incompatibility with physiological fluids.
Our services also include the development of specialty sustained release systems, such as microspheres, nanospheres, liposomes, depots, etc. The company hopes to form liaisons and collaborations with start-ups and larger companies alike. Integral BioSystems, LLC was founded by experienced drug development professionals with combined expertise in drug delivery, formulation development and CMC. The company has adopted a translational medicinal approach to drug development, customizing delivery systems to accomplish the biologically effective objectives of the therapy.
Delivery systems are customized to achieve sustained release or targeted, tissue-focused delivery, or fast-release/instant delivery, depending upon the desired product attributes. Once the drug-containing formulations are tested in preclinical models, an integrated CMC plan is developed to systematically transition the project to scale up and product development. As part of product development, Integral BioSystems specializes in efficiently developing a dosage form to manufacture and test in Phase I/Phase II first-in-man trials for proof-of-concept. The company has a network of manufacturers / analytical houses for pharmaceutics, that can fast-track the manufacture and release of the sterile dosage form for first-in-man trials.
Integral BioSystems also recognizes the need from both small and virtual clients to further supplement their current service offerings by providing consultant services. Consultant participation will be available at the task, project and program level. Integral BioSystems offers a full range of consulting services to complement our formulation development, manufacturing and analytical services.
We can provide “stand alone” development consulting or intertwine it with our other service offerings. The services we offer with our drug development program consist of pre-formulation, formulation development, analytical method development, preparation of toxicological materials, then development of the formulation into formats that will be applicable to clinical dosing in the route of administration. Integral BioSystems scientists will scale-up the formulation preparation and technology transfer to an aseptic, GMP manufacturing site for final packaging of CTM. We assist in each step, from project management and consulting, integrated to our development services. Contact: info@integralbiosystems.com 781-879-4677.