Our Services, And More Information :: Product Development Program - Formulation Development - Clinical Manufacturing

Experience & Expertise:
At Bio-Concept, we have the years of practical experience and expertise to get your product to clinical trial quickly. And we have particular experience with ophthalmics and injectables. In particular, the staff at Bio-Concept has extensive expertise in the following areas:

product development formulation technology microbiology analytical chemistry aseptic fills

formulation science stability process research pilot scale-up manufacture

Formulation:
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.

Assay Method Development and Validation:
At Bio-Concept, we are highly experienced in developing, qualifying, validating, and comprehensively documenting analytical methods for dosage forms. Our method development services cover a full range of analytical methodology including wet chemical, high-pressure liquid chromatography (HPLC), and gas chromatography (GC). The analytical group employs state-of-the-art Water's Alliance 2695 and Agilent’s Series 1100 HPLCs with multiple detectors including photo-diode array (PDA), UV/Vis, and refractive index (RI). For final dosage forms, we develop stability-indicating assays and validate the method for active compounds and preservatives. These procedures support finished product testing and stability studies.

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:

• System Suitability
• Forced Degradation
• Accuracy
• Linearity
• Ruggedness (Intermediate Precision)
• Limit of Quantitation (LOQ)
• Limit of Detection (LOD)
• Precision
• Recovery
• Robustness
• Range
• Specificity

cGMP Testing and Stability:
Bio-Concept offers cGMP finished product and stability testing to support the pharmaceutical, ophthalmic, and medical device industries. We also test for method development and validation, product compatibility, accelerated stability, technical troubleshooting or any customized product investigation. Our quality control services include a wide array of current USP/NF tests. And our stability program is designed to store and test your product under ICH and FDA temperature and humidity controlled conditions. Best of all, all the support you need to test and release your product is on site, enabling your company to work with us from start to finish.

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

Antimicrobial Effectiveness Testing Bacterial Endotoxins (Limulus Amebocyte Lysate) (LAL) Bioburden Ultraviolet Spectroscopy Formulation Development GC Analysis HPLC Analysis Methods Development and Validation

Microbial Limits Tests Osmolality pH Stability Testing Sterility Testing Viscosity Water Determination (Karl Fischer)

During the stability stage, we are developing stability information that are added to the comprehensive documentation we prepare for each project. We even produce interim stability reports for clients to submit to the FDA.

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 alarm service for emergency notification.