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By Phil Nixon, Jay Lakshman, and Keirnan LaMarche

Phil Nixon-finalJay Lakshman-finalKeirnanLaMarcheThe pharmaceutical industry is going through a period of dramatic change, and incremental improvement to the decades-old batch manufacturing paradigm is no longer sufficient. Fortunately, 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 a 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, among many other advantages. Surprisingly, however, the significant potential of continuous processing has not yet been exploited in the pharmaceutical industry despite significant investments over the last decade and an accelerating pace of industry uptake.

arden-house-2015_only-art01This year’s Arden conference is focusing on the advances in the continuous manufacture of tablets, capsules, and other OSD forms. Currently, pharmaceutical manufacturing is primarily carried out by batch processes. Examples of batch processes abound in daily life; from baking cookies to washing clothes. Batch manufacturing has been preferred over the last century of pharmaceutical manufacture due to its flexibility and ease of design. However, producing batch after batch of material with consistent quality attributes is a constant challenge. As quality by design becomes an ever more important facet of pharmaceutical manufacture, continuous manufacturing has become an attractive alternative to batch production methods. Continuous manufacturing is a technique, developed over a century ago, that allows the quality of the product to be more easily controlled during the operation. In a continuous process, operating at steady state conditions, the properties of the product do not change with time at any point in the process. This allows the process to adapt to variation encountered during manufacture and produce a product with consistent properties.

The conference should be of great interest to pharmaceutical scientists, commercial manufacturing personnel, regulators, and academics who are seeking to understand continuous manufacturing for OSD and how it may transform development and manufacturing. Continuous Manufacturing of Solid Oral Drug Products, will be held March 16–18 in Baltimore. Full program and registration details can be found at www.aaps.org/Arden. The conference 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. 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.

We hope you can attend and contribute to the conference.

Phil Nixon, Ph.D., is the program lead for Pfizer’s Portable, Continuous, Miniature & Modular development and manufacturing initiative. Working in a technology and innovation group, he supports technology strategy development and execution.
Jay Lakshman, Ph.D., is a global technical project management leader at Novartis, working on portfolio projects and oral technology platforms. Enabling poorly soluble drugs and simplifying pharmaceutical dosage forms and manufacturing process are areas of his research interest.
Keirnan LaMarche, Ph.D., is a senior research investigator for the Drug Product Science and Technology department of Bristol-Myers Squibb. He has worked on innovative approaches to formulation and process development for solid dosage forms at BMS since 2008.