Bio Concept Laboratories - Ophthalmic Product Development

Bio-Concept Laboratories is an FDA registered contract research organization (CRO) and contract manufacturing organization (CMO). We offer a full range of ophthalmic product development services including formulation, analytical method development, microbiology testing, aseptic sterile cGMP manufacturing and stability.

Our clients are predominantly ophthalmic companies from the biotechnology, pharmaceutical and medical device industries. They range from start-up, virtual, mid-sized and mature companies.

Our recent expansion into a 30,000ft ² facility in Salem, NH positions Bio-Concept for continued growth as we expand our services to address the needs of a diverse and growing client base.

Integrated ophthalmic product development program – market efficiency

Bio-Concept has developed an integrated product development program designed to bring your new product to market, efficiently and effectively. The status, strategy and assumptions are routinely reviewed with the client and modified as appropriate. Each project is assigned a project coordinator to give you and your project the personal attention you both deserve.

Development of ophthalmic formulations

Our expertise in the development of ophthalmic formulations allows Bio-Concept to anticipate and address challenges that are unique to ophthalmic products. We offer specialized insight into preservative systems, ingredients, buffers and other excipients.

Flexible hand-fill processing

Aqueous solutions, emulsions and suspensions are formulated and filled into plastic bottles with a dropper tip and cap. We also have experience with gels and ointments. Our flexible hand-fill process allows us to customize manufacturing requirements to address a variety of fill volumes and container options.

Our experience allows us to identify, early on, the most challenging items that could potentially affect the success of the project. We also assess the validity of our approach. In this way, we can predict and overcome possible delays while minimizing your costs.

Pre-formulation studies determining drugs' physiochemical properties

During this process, Bio-Concept characterizes your product and how it behaves. Pre-formulation studies are conducted to determine the physiochemical properties of drug substances and excipient interactions. This is a crucial part in developing an optimized formulation.

We also look how your product behaves with different ingredients and fine tune the formulation. Ultimately, we optimize your product around different parameters, determining the order of addition of ingredients, compounding limitations, equipment compatibility, and their impact on manufacturing, product performance, and stability.

All this helps us create an appropriate formulation that will not only withstand FDA scrutiny, but will also help quicken the successful launch of your product.

Analytical assay method validation

At Bio-Concept, we are highly experienced in developing, qualifying, validating, and comprehensively documenting analytical methods for raw materials, process streams, dosage forms and cleaning operations.

Our method development services cover a full range of analytical methodology including wet chemical, high-pressure liquid chromatography (HPLC), gas chromatography (GC). The analytical group employs state-of-the-art Water's Alliance 2690 HPLCs and routinely applies a photo-diode array detector for method development and validation.

For bulk drug and final dosage form, we develop stability-indicating assays and validate the method for active compounds and excipients. These procedures support finished product testing, stability studies, the analysis of batch residuals and cleaning agents.

Bio-Concept will customize a method validation protocol to your specifications and to meet current ICH or USP / NF requirements. Methods are validated for the following parameters:

• Accuracy
• Linearity
• Ruggedness (intermediate precision)
• Limit of quantitation (LOQ)
• Limit of detection (LOD)
• Precision
• Recovery
• Robustness
• Range
• Specificity

Aseptic sterile clinical manufacturing

The manufacturing process stage is similar to creating a recipe. We determine what ingredients should go into the formulation, at what intervals and under what conditions. It is another instance where our experience proves to be invaluable.

Each customer has different needs and different requirements. That's why Bio-Concept's clinical manufacturing program offers so much flexibility. We will work with almost any customer configuration and support a variety of testing procedures. We will make sure your product is ready for clinical trial and manufacture.

The master batch record precisely outlines all the steps needed to manufacture your product for clinical use. As part of our clinical manufacturing program, Bio-Concept creates a comprehensive master batch record suitable for all clinical needs and FDA approval.

In an effort to further reduce your time to clinical trial, Bio-Concept can label your product to avoid delays in using an outside company.

Bio-Concept has the flexibility to work with many different types of configurations. These include:

• Plastic bottles with dropper tips and caps from 3mL to 15mL
• Glass vials 2ml to 20ml
• Volumes from 0.5ml to 15ml
• Batch size of 2,000 units
• Filtration
• Bulk solution autoclave
• Split-phase

Analytical chemistry and microbiology cGMP testing

Bio-Concept offers both cGMP and stability testing to support the pharmaceutical, ophthalmic, and medical device industries. We also test for method development and validation, product compatibility, accelerated stability, market claims, technical troubleshooting or any customized product investigation.

Bio-Concept performs analytical chemistry, biochemistry, and microbiology cGMP compendial testing for medical devices, ophthalmics, and Rx and OTC pharmaceuticals. In addition to maintaining high quality processes, we turn around the tests rapidly to ensure the client's timelines are met.

Stability programs

Bio-Concept is equipped with precisely controlled environmental chambers to simulate long-term temperature and humidity conditions according to ICH or FDA guidelines. In addition to the traditional accelerated stability studies, we perform rapid degradation profiles of samples to quickly assess the product options. All of our chambers are connected to an outside alarm service for emergency notification.