Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges must be immediately addressed to keep timelines on track. In early-stage OSD formulation development, complex solubility issues, difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API) all can lead to delays in development. During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physicochemical characteristics of a product.
Market trends push the boundaries on the development cycle or speed of the drug product, opening possible gaps in understanding multi-variable interactions such as raw materials, manufacturing processes, packaging, and storage on the critical quality attributes of the drug product. Therefore, "it is critical to design tests that examine the interaction of multi-variables on the (OSD) drug product," states Mark Lewis, Alcami Site Director, Wilmington Drug Product Manufacturing Operations.
Allocating design space resources and tolerance to modifications in the drug product helps support manufacturers in staying ahead of OSD challenges and, furthermore, “the backing of highly trained scientists who handle diverse projects in state-of-the-art development and manufacturing facilities certainly helps us understand challenges and overcome them before it becomes problematic,” says Lewis.
As quality and safety expectations increase, companies should pursue technical services improvements to stay relevant in the ever-evolving pharma and biologics space. For instance, serialization implementation has become mandatory in the United States. Substantial investment is required to build a sustainable solution that is compliant with Drug Supply Chain Security Act (DSCSA) requirements. With serialization, you must deploy packaging line equipment and software to support OSD forms in bottles, blisters, and cartons. One of Alcami’s most significant technical advancements has been the implementation of serialization and aggregation capabilities.
“It takes a highly-skilled, cross-functional team across operations, package design, and validation to bring to fruition added equipment and technology to the packaging lines,” says Michael Reel, Alcami Director, Technical Services. “This integration delivers improved product quality through enhanced traceability and packaging line inspections.” Alcami’s serialization software allows for data transfer with trading partners to perform careful management of master data across different platforms. Alcami has successfully transitioned clients into its serialization program with the help of these systems and processes.
Another opportunity to prevent delays in OSD development is to commit to operational excellence. Companies must continuously evaluate processes to identify waste reduction opportunities. “5S implementation has helped us eliminate the waste of searching for equipment and working around items that do not belong in the workspace. The use of shadow boards allows us to quickly ensure all parts are available for equipment set-up,” states Marty Shelton, Alcami Vice President, Global Operational Excellence. “Such changes have been implemented using at-a-glance visual management. These types of enhancements help improve quality and reduce turnaround time, which are both critical in meeting customer needs.”
In conclusion, right-first-time OSD products depend on robust formulations, staying current in a fast-paced industry, and reducing waste. Alcami strives for superior quality through integrated teams involving technical, quality, and manufacturing teams and by doing what’s right, not what’s easy.
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Mark Lewis, Site Director, Wilmington Drug Product Manufacturing Operations
Michael Reel, Director, Technical Services
Marty Shelton, Vice President, Global Operational Excellence