Science at the interface
of biology and chemistry

Contract Research Organization

Serving bio-pharmaceutical companies since 2009

Integral BioSystems offers quality, high-end R&D and cGLP technical services in specialty drug formulation development services for a variety of dosage forms.

Integral Biosystem

Drug development experts

Integral BioSystems specializes in formulation development, analytical method development and scale-up /technology transfer of ophthalmics, dermals, injectables, otics, pulmonary, intranasal and rectal dose forms. 

We offer sustained release drug development expertise and know-how including injectable microspheres, liposomes, hydrogels, nano-complexes and micro/nanocrystals. 

Additional contract research organization services include GLP formulations for toxicology supplies and non-GLP bioanalytical analyses. Additionally, the company offers licensable, patent-protected delivery systems (OcuHeal™ and NanoM Wafer™) for 505b2 products. 

To date, Integral has developed complex formulations and dosage forms for small molecules, proteins, peptides, nucleic acids and small molecules. 

Why choose us

Based in Greater Boston, Integral BioSystems was founded by drug development experts with 50+ years of combined expertise in pharmaceutics and the development of drug products.

Our mission as a contract research organization is to transform research concepts from the lab to clinic-ready products using the highest standards of scientific excellence.

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50+ years combined experience
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10,000 sq ft cGLP compliant lab
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Competitive price
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Commitment to quality, integrity, safety and excellence
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Fast turnaround
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Clients trust us since 2011

We Offer a Systematic Step-wise Drug Development Program

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The success of a project is dependent on the big picture as well as the tactical details. Failure in either can result in loss of time and money for your company. While 50,000 feet strategy development is done as part of your goals development, Integral BioSystems can offer key input into the risk/benefit analyses of each strategic approach to assist the development team. This could range from the budgetary requirements, as well as regulatory considerations to get the drug from the laboratory to its validation in the clinic. 

Tactical details flows naturally from the big picture. Integral BioSystems develops a detailed project plan to take the concept from the laboratory to the clinic. 

Drug Formulation & Delivery Services

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CRO services

We specialize in the development of complex formulations and dosage forms for a wide range of applications including ophthalmics, dermals, injectables, otic, pulmonary, intranasal, oral, sublingual and rectal dose forms.

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Collaborations

We invite fee-for-service collaborations with pharmaceutical companies leveraging our technology expertise in Cyclodextrins, Lipid Nanoparticles, Microencapsulation, and Nano- & Micro-Crystallization for new drug development.

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Licensable technologies

Our NanoM Wafer™ and OcuHeal™ platform technologies have been patented globally. We welcome collaborations with pharmaceutical companies to render repurposed drugs IP-protectable with our drug delivery platforms.

Email us to discuss your next project

Newsroom

Press releases, newsletters & articles

Integral BioSystems to Exhibit at 2024 ARVO Annual Meeting in Seattle Washington May 5 to May 8 2024
https://www.einpresswire.com/article/694152500/integral-biosystems-to-exhibit-at-2024-arvo-annual-meeting-in-seattle-washington-may-5-to-may-8-2024

What our
clients say

Work with us

Do you want to join our contract research organization?

We are always looking for professional and inspired people who want to work according to our principles and standards. Look through our list of open positions or contact us to find out about job opportunities.

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Some of our amazing customers

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Clients
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FAQs

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. 

Contact us

To contact us about a project, please include a brief summary of your specific needs with your email.
Our company representative will call you back within the next business day.

    Let us help you with your next project.

    April 2024 Newsletter

    Integral BioSystems, a contract research organization focused on drug delivery and development, announces the publication of a monthly newsletter. We will update our collaborators on

    Learn more