Given the broad range of clients in the OSD manufacturing market, there is a hive of activity surrounding the topic. On one end of the spectrum, there are companies with extensive knowledge and experience in drug development, looking for a partner that can provide capacity. On the other end, there are emerging organizations seeking expertise in bringing their product through the various phases and to the market. Recognizing that these companies are an innovation engine for the industry, Alcami focuses on understanding and serving them to drive change and positively impact the industry through the development and launch of new treatments.
Today’s OSD formulations are becoming more complex. Compounds with low solubility and/or high potency demand innovative formulas to achieve the desired results. Sustained release and controlled release formulations remain increasingly popular. Throughout the manufacturing process, sources of potential extractables and leachables must be identified.
Moving forward, a major driver for business success is flexibility. While plans are made and schedules defined before the project begins, knowledge gained as the project progresses requires adjustments to the schedule. One of the most challenging aspects is maintaining the agility and flexibility to react to changing protocols. The ability to communicate effectively and to make adjustments rapidly and smoothly is key to bringing projects to fruition. Client requirements in early phase studies often evolve based on clinical results. This frequently means redevelopment or expansion of the dosage range covered by manufacturing. Being able to respond to changes that benefit the patient is critical to our success as a CDMO.
The OSD development through the manufacturing pipeline of products is expanding at a robust rate—even while the industry watches the investment, interest, and demand for biologics and biosimilars growing rapidly. There are several reasons OSDs continue to be the most popular dosage form for getting drugs to patients. In addition to being cost-effective and relatively easy to make compared to their large molecule counterparts, they are most importantly, patient-friendly, especially among the pediatric and geriatric populations.