Ophthalmic Formulation Development Services
Integral BioSystems delivers ophthalmic formulation development services with 50+ years of combined experience, making it one of the few premier CROs focused on ocular drug delivery.
A significant challenge to ocular drug delivery scientists is the necessity to circumvent the protective barriers of the eye without tissue damage. The goal of ophthalmic drug delivery is the design of therapeutic systems that will achieve optimal concentrations of the selected drug at the target tissue for an appropriate duration.
Ocular disposition and elimination of a therapeutic agent is dependent upon its physico-chemical properties as well as the relevant ocular anatomy and physiology. As much as 95% of the total volume of the ophthalmic solution is lost by drainage into the lacrimal duct, tear turnover, and conjunctival absorption. Thus, for acceptable bioavalability, a proper duration of contact with the cornea must be maintained.
Factors that are important in the design of ophthalmic delivery systems are the intrinsic permeability of the drug through the various ocular tissues, such as the cornea, sclera, etc., the biocompatibility of the delivery system with ocular tissues; and the ability of the delivery system to “deliver” a predictable concentration of drug over the desired time duration.
CRO Services for Ophthalmic Drug Delivery
- Integral BioSystems has a special focus on ophthalmics, with approximately 80% of our clients in ophthalmic drug development. We aim to design ophthalmic formulations that are chemically stable and are designed to have minimal systemic exposure and high local concentrations at the site. Furthermore, we design our research formulations to be scalable and transferable into clinical dosage form development.
- We design ophthalmic products for both back-of-the-eye and front-of-the-eye indications.
Types of Ophthalmic Formulations
These dosage forms can be developed on a fee-for-service basis for our clients.
- Suspensions
- Solutions
- Injectables-Sustained Release
- Microspheres
- Depot formulations
Capabilities
- Expert Guidance
- Method Transfer/Method Development
- Development of Target Product Profile
- Compatibility Studies with excipients
- Prototype Fabrication and characterization
- Permeability Studies of drugs through Corneal and Scleral Tissues
- In-Vitro Compatibility Studies of the drug with ocular tissues
- In vitro release experiments
- Stability studies of the ocular formulation
- Container closure compatibility
- Scale up and tech transfer
Ocular Drug Delivery Development Platform Technologies
Beyond fee-for-service formulation work, Integral BioSystems owns two licensable platform technologies built specifically for ocular drug delivery development. The NanoM Wafer is a biodegradable, bioadhesive ocular insert placed in the lower conjunctival fornix, where it hydrates into a translucent hydrogel and releases the incorporated drug over a sustained period without requiring surgical removal. OcuHeal LNP is a licensable lipid nanoparticle platform designed for eye drop formulation development that reaches deep ocular tissue, offering a non-invasive option to evaluate alongside intravitreal injection for posterior segment candidates. Both platforms are available for licensing alongside Integral BioSystems’ contract formulation work.
Facilities & Equipment
- R&D labs in operation since 2011;
- cGLP compliant in 2018;
- 10,000 square feet of office/lab space
23 Crosby Drive,
Suite 100A,
Bedford, MA 01730
50+ Years of Combined Experience
Our scientific staff operates with the highest standards of integrity, quality, excellence, and safety, with the ultimate goal of doing good science.
CEO Shikha Barman, PhD, has 27 years of experience in drug development with numerous patents and publications in drug delivery, biomaterials, and gene delivery. She was inducted as a Fellow in 2021 by AIMBE for her contributions to drug delivery. Dr. Barman’s background spans ophthalmic, injectable (IM), and dermal (sublingual and targeted therapies). She was featured in C&EN and ACS in the April 2013 issue as one of four women entrepreneurs to watch, and a Technology Showcase winner in 2015 in CRO/CMO, Boston, MA.
COO and Company IP Attorney Dave Karasic is Integral’s first investor. He brings 35 years of engineering, IP, and legal experience to the company.
Why Choose Integral BioSystems
- Over 80 percent of client programs are ophthalmic, giving Integral more than 20 years of concentrated ocular formulation experience most CROs of this size do not have.
- Two proprietary, licensable platforms, the NanoM Wafer ocular insert and OcuHeal LNP, available alongside fee-for-service formulation work.
- A two-tier quality system, Tier I for early exploratory work and Tier II under 21 CFR 58 cGLP, so a program does not need to change CRO partners as it advances toward IND-enabling data.
- Led by CEO Dr. Shikha Barman, PhD, with more than 30 years of drug delivery experience, 35+ US patents, and AIMBE Fellow recognition.
- Trusted by biopharma companies from small biotech to larger pharma, including Alcon, Regeneron, and Nacuity Pharmaceuticals.
- Competitive pricing and fast turnaround without stepping outside cGLP-compliant facilities and equipment.
- Woman-owned business.
Some of our amazing customers
What Our Clients Say
Ophthalmic Formulation Development Services FAQs
What Is the Difference Between Anterior and Posterior Segment Ophthalmic Drug Delivery?
The anterior segment includes the cornea, conjunctiva, aqueous humor, iris, ciliary body, and lens, and it is generally reachable with a topical formulation because the drug only has to cross the corneal epithelium and the blood aqueous barrier. The posterior segment includes the vitreous, retina, choroid, and optic nerve, and it sits behind the sclera and the blood-retinal barrier, so a conventional eye drop typically delivers only a small fraction of its dose to that tissue. This is why posterior segment programs usually require an intravitreal injection, an implant, or a sustained-release platform such as the NanoM Wafer, rather than a topical solution.
How Does the NanoM Wafer Ocular Insert Control Its Release Rate?
The NanoM Wafer is placed in the lower conjunctival fornix, where it hydrates into a translucent, bioadhesive hydrogel rather than dissolving or requiring surgical removal. Formulation scientists adjust the matrix composition of the wafer, not the dosing schedule, to lengthen or shorten how long the drug is released. Because the insert stays in contact with the ocular surface rather than washing away with tear turnover, it is suited to programs where a conventional eye drop cannot maintain enough contact time for the target concentration.
What Quality System Governs Ophthalmic Formulation Development at Integral BioSystems?
Integral BioSystems runs a two-tier quality system. Tier I supports flexible research and development work for early exploratory ophthalmic formulation and method development, and Tier II operates under 21 CFR 58 cGLP compliance for regulated, submission-grade ophthalmic studies. A program can move between the two tiers as it advances from early feasibility work toward IND-enabling data, without changing CRO partners.
How Does OcuHeal LNP Reach Deep Ocular Tissue From an Eye Drop?
OcuHeal LNP encapsulates the active ingredient in a lipid nanoparticle designed to move past the barriers that stop most eye drop formulations at the corneal or conjunctival surface, reaching tissue deeper in the eye without an intravitreal injection. This gives a formulation team a non-invasive option to evaluate for posterior segment candidates before defaulting to an injectable or implant-based delivery route.
What Happens After Integral BioSystems Signs a Confidential Disclosure Agreement for an Ophthalmic Program?
Every engagement begins with a Confidential Disclosure Agreement, followed by a scoping meeting that reviews existing data, the clinical indication, the intended route of administration, and the specific formulation challenges of the candidate. From there, Integral BioSystems builds a strategic plan and a detailed project proposal with cost evaluation before starting the 15-step development program that carries the candidate through formulation, analytical work, and technology transfer.
Get a Quote for Your Ophthalmic Formulation Development Program
Integral BioSystems designs and executes ophthalmic formulation development services for anterior and posterior segment candidates, from early feasibility work through cGLP-compliant tech transfer. Contact Integral BioSystems today to discuss your ocular drug candidate and receive a project-specific quote.