CMC

(Chemistry, Manufacturing, and Controls)

The Chemistry, Manufacturing, and Controls activities required during the development of pharmaceutical products are highly complex. For this reason, it is quite common for pharmaceutical companies to encounter significant CMC obstacles during the development process.

Ora can provide the critical CMC expertise needed to advance drug candidates along the clinical regulatory pathway toward the ultimate goal of NDA approval. Our CMC team possesses extensive industry experience in all aspects of pharmaceutical development including:

• Compound synthesis
• Formulation development
• Analytical testing and controls
• Manufacturing
• Clinical supplies
• Delivery systems

We specialize in liquid, semi-solid, and sterile product development and have an in-depth understanding of the unique challenges these dosage forms present. Our team has been directly involved with the chemistry and manufacturing of many approved ophthalmic drugs, and can provide assistance from formulation design and preservative selection to commercial scale-up and manufacturing control strategies.

Ora’s deep experience is specific to ophthalmology. We are experts in identifying the challenges unique to ophthalmology across formulations that include solutions, suspensions, emulsions, and ointments. We can also provide expert guidance in the areas of preservatives and preservative compatibility, stability testing, dealing with difficult compounds, working with polymers, manufacturing processes, risk management, aggressive project management of vendors/suppliers, as well as CMC sections for pre-IND, IND, EOP2 packages, and NDAs.

Ora’s in-house chemistry laboratory enables our CMC team to rapidly create and evaluate formulation prototypes in a seamless manner alongside Ora’s clinical research departments. We also maintain ongoing strategic relationships with several cGMP test laboratories and manufacturing facilities that provide us with preferred pricing and scheduling of manufacturing campaigns. We offer expert project and contract management and integrate closely with clinical research groups to deliver investigational material for clinical trials on time and within budget. We can also formulate supplies for toxicology testing in-house.

Ora is very flexible, and can provide everything from individually tailored services to complete turnkey CMC programs. Larger clients with their own internal resources often cherry-pick individual services, or engage Ora to serve on a consulting basis to review plans, help trouble-shoot, or participate in calls with vendors.

Many smaller clients look to Ora to provide full turnkey services, including formulation strategy work, interface on IP, formulation development and screening, assay development, stability testing, manufacturing process development, managing the process to secure supplies for clinical trials, integrating COAs into regulatory filings, and following stability.

By providing in-depth scientific knowledge and extensive practical experience in pharmaceutical development, we can help advance drug candidates toward market success in the most efficient manner possible.

For more information, please contact George Minno, PhD, Director of CMC, at (978) 685-8900, ext, 9435 or at gminno@oraclinical.com.