Integral BioSystems scientists are drug delivery and drug development experts, specializing in complex products, such as nano- and micro-suspensions and sustained release delivery systems such as microencapsulated products. We are also specialists in the formulation development of protein-based and nucleic-acid based biopharmaceuticals. Additionally, Integral offers rapid testing of formulations such as particle size distributions, osmolality, viscosity, MW determinations and ICH stability testing. 

This depends upon the project, type of therapeutic and available CMC data. For example, every project needs analytical development, pre-formulation, generation of formulation prototypes, short term stability, process development and scale-up. Call us with your project details, and we will advise. 

Many of our clients proceed rapidly from formulation development to toxicology studies. Integral is well situated to generate toxicology supplies with GLP-qualified analytical methods. We can release product cGLP, and perform extended stability studies with ICH guidelines. 

Integral BioSystems is not a cGMP facility and cannot manufacture product. We develop the product, develop analytical methods, perform cGLP validations, generate and release toxicology supplies, perform cGLP stability studies and tech transfer to a cGMP facility. 

We are happy to discuss your project and propose a development path.

Integral has considerable experience with biologics drug products, in ophthalmics and injectables. We are happy to discuss your project and propose a development path. 

OcuHeal™ was developed by Integral BioSystems. The technology is a platform lipid nanoparticle delivery system, designed to transport molecules through biological membranes such as the cornea, sclera, hair follicle, stratum corneum and intranasal epithelia. The technology is being developed for a multitude of ocular, otic, intranasal and dermal applications via Integral’s wholly owned subsidiary Symphony Therapeutics. The product under development is OcuHeal-UV400+. The technology is fully patented in 12 global jurisdictions. Additionally, OcuHeal product platform is trademark pending. CEOs, if you have a molecule that needs enhancement of bioavailability, contact us for a discussion. 

The NanoM Wafer™ technology was developed by Integral BioSystems and fully patented in 12 global jurisdictions. Additionally, the name of the platform is trademark pending. The NanoM Wafer is a thin film wafer technology that was initially developed for the eye. Without a drug, the NanoM Wafer technology can act as a corneal bandage and allow healing of the underlying tissue. The wafer is dissolvable or non-dissolvable, and is platform. The wafer can be designed to deliver sustained concentrations of drug to a mucosal surface. The process is gentle and maintains integrity of labile molecules such as proteins, peptides and nucleic acids. Contact us for a discussion.