2015 Arden Conference
The pharmaceutical industry is undergoing great change, and incremental improvement to the decades old batch manufacturing paradigm is no longer sufficient to ensure viability. Fortunately, broad implementation of continuous manufacturing in both API and drug product arenas has great potential to address industry needs. This workshop will provide participants with an up-to-date and in-depth understanding of the benefits, technologies, formulation/process design practices, the degree of uptake within the industry, regulatory considerations and implementation challenges associated with continuous manufacturing for oral solid dosage forms (OSD). Case studies will be used to demonstrate “state-of-the-market”, gaps and emerging OSD continuous manufacturing technologies, including automation and measurement systems necessary to integrate equipment in a continuous process train.
Goals and Objectives
The pharmaceutical industry is going through a period of great change. Fewer blockbusters exist, while the emergence of precision/personalized medicines and rare/orphan drugs is driving the industry towards more products with smaller volumes. Additionally, local manufacturing is increasingly important for diverse geographic markets. Further, despite increased portfolio complexity, pressures are mounting to achieve a market demand-driven supply chain with reduced lead-time requirements that is more responsive to volume uncertainty. Clearly, incremental improvement to the decades old batch manufacturing paradigm is no longer sufficient for Rx, OTC, and nutraceutical viability.
Broad implementation of continuous manufacturing has great potential to address the needs of the pharmaceutical industry. Indeed, end-to-end continuous manufacturing processes are being implemented that integrate several oral solid dosage (OSD) unit operations, thereby achieving the transformation of raw materials to film-coated tablets in the matter of minutes. With continuous manufacturing systems, it is possible to “scale out” with run time or clones, which enables new inventory management approaches. This flexibility also makes it possible to use the same equipment for development and commercial manufacturing, minimizing the need for scale-up/tech transfer. Other advantages offered by continuous manufacturing are numerous and include smaller equipment footprint (and therefore cGMP processing area), interchangeable unit operations (i.e. mills, blenders, tablet/capsule machines and optional dry granulation in an existing direct compression or wet granulation line) shorter cycle times, inventory reduction, improved yields, reduced capital costs, and improved control over quality. Indeed by not requiring large bulk handling, continuous processing can enable simpler manufacturing trains (direct compression vs granulation) in some cases. Not to be overlooked, in contrast to traditional batch processing, continuous manufacturing (combined with Process Analytical Technology and Controls) facilitates exploration of process variable space to collect a large dataset during a single run. These advantages can therefore reduce API needs, development and manufacturing costs and timing, as well as the risk of product failure and stock-outs.
Despite the significant investments in continuous manufacturing development over the last decade and fast pace of industry uptake, the significant potential of continuous manufacturing has not yet been exploited. Fortunately, however, significant momentum has been building for several years, and a number of academia and industry companies are actively working to implement continuous manufacturing for oral solid dosage forms.
This conference will provide an up-to-date and in-depth understanding of the technologies and challenges associated with continuous manufacturing for OSD. It will also provide a forum for the pharmaceutical industries, equipment vendors, academia and regulatory agencies to engage in discussion to transform pharmaceutical manufacturing. Specific goals and objectives include the following:
- Communicate a vision for how OSD continuous manufacturing can be broadly implemented in the pharmaceutical industry, for both development and commercial (e.g., product switchovers) arenas.
- Present case studies to demonstrate “state-of-the-market” and emerging OSD continuous manufacturing technologies.
- Provide fundamental engineering aspects associated with continuous processing (e.g., control volumes, residence time and distribution, non steady-state startup and shutdown considerations) and equipment not commonly used in batch processing (powder feeders, continuous blenders and dryers).
- Provide an understanding of the automation (Local and Supervisory levels) and measurement systems (eg, Process Analytical Technology) necessary to integrate equipment in a continuous process train.
- Share contemporary formulation and process design space practices, especially as they are evolving to support continuous manufacturing.
- Address regulatory considerations and control strategy (using real-time principles) for OSD continuous manufacturing, both for new and existing products.
- Due to its cost-effectiveness and simplicity, highlight approaches to enable continuous direct compression processing across a wide formulation space.
- Discuss how to convert existing batch processes to continuous processes.
- Discuss practical limits (pragmatic or equipment limits) for scaling to both small and extremely high throughputs.
- Delineate technology, organizational and cultural barriers to implementing continuous manufacturing.
Who should attend?
Pharmaceutical scientists and commercial manufacturing personnel that are seeking to understand continuous manufacturing for oral solid dosage (OSD) forms and how it may transform development and manufacturing.
- Formulation/process design and development scientists, managers, and leaders
- Process engineers
- Measurement scientists
- Materials/powder science scientists
- Automation/Advanced Process Control engineers
- Regulatory CMC personnel
- Pharmaceutical sciences project leaders
- Contract Manufacturing Organization scientists and management
- OSD equipment, automation, and in-line analysis vendors