Process Selection

Operations management can be defined as the activities that produce goods and services. At sanofi-aventis, an operation entails the culmination of pharmaceutical operations, industrial affairs, and research and development to produce regulated medications/drugs for our sound health.

Sanofi-aventis utilizes two product flows; Project and Batch Flow. A Project form of operations is used for products in the Research and Development stage. New medications at Sanofi-Aventis start in the Project form because they are working on one unique product and, while each new drug may have a very small amount of process similarity, the majority of the process needs to be approached as though it were being done for the very first time. This process form requires highly skilled research technicians and low or no automation in the process. Once the drug is approved by the FDA, the process then changes to a Batch flow. A Batch flow is characterized by the production of a product in batches or lots. Batch operations often use general purpose equipment that is not specialized to make just one particular product, but several, which offers great flexibility. For example, at Sanofi-Aventis, each batch of the product moves from one work center to the other. The tablet making process begins with blending/mixing and then moves on to a dryer. Next the product moves to the tablet press and finally to the tablet coater. Each of these machines can be reused to make different medications. The only difference might be which press is used to shape the raw powder into either round or special shaped tablets. Each batch is then assigned an expiration date and lot number. A Batch processes can be configured to handle low as well high volume orders.

Sanofi-aventis is currently celebrating the approval of Multaq® in the United States by the Food & Drug Administration in the United States. Multaq® is a multichannel blocker that inhibits various ion channels of cardiac cells. It is the first antiarrhythmic that has demonstrated in patients to decreased the risk of cardiovascular hospitalizations or death from any cause as well as the risk of stroke when used on top of standard therapies. This drug will now be making the leap from the Project Process to the Batch Process of manufacturing.

Batch Production of Tablets in Pharmaceutical Manufacturing

Products at sanofi-aventis are made-to-stock (MTS) which provide faster service to customers and reduces cost. The products are carried in inventory to immediately fulfill customer demand. Sanofi-Aventis carries a standard product line where medication strengths are specified by the producer and not by the customer. The customer cannot request a customized strength for his/her particular needs as all tablets of that particular brand are made identical and produced in advance. Although this does not provide the most flexibility to each particular customer, it enables amble inventory to be available to satisfy the customer need as soon as possible. After all, imagine if you were very sick and needed to wait for your medication to be manufactured before you can begin your course of antibiotics to begin to feel better? You most likely would not be very happy with the wait. There are some upsides to a more customized, made to order pharmaceutical, which will be addressed, but speed and cost trump the benefits of this option for the most part.

Sanofi-aventis falls in the project make-to-order/assemble-to-order category for new products that are still in the research and development phase and batch flow make-to-stock category of the Process Characteristics Matrix for finished goods products.

Of the four factors that appear to influence process selection, sanofi-aventis relies mostly on Labor, Technology and Market conditions. The industry dictates that sanofi-aventis hire skilled labor in the areas of chemistry, biology and pharmacology, which pay high salaries. The company must also consider the latest software suites and production machinery to enable more efficient productions while providing higher quality products. Pharmaceutical companies are also forced to straddle both the project and the batch process due to the fact that they only have the exclusive right to a drug for a certain period of time after its introduction to the mass market. After that point, revenues drop significantly as generic equivalents enter the market place. They need to constantly have project teams in place working on the next best thing to remain competitive. The company needs to use a batch flow rather than an assembly line process for two reasons. The first constraint is that they are bound by the shelf-life of the product and compliance with regularly changing FDA regulations. If the company mass produces a product and there is an FDA recall or the product expires prior to purchase, they stand to lose a large amount of revenue.

Mass customization would essentially entail making a different product for each customer. Although it would be the ideal option for each customer, it would be very difficult to implement in the pharmaceutical industry. Not only would the process have to be changed from MTS to MTO/ATO, the cost would be very high and the customer would have to wait for their medications to be custom made. An ideal outcome of the mass-customization of medications may be the fact that people that were on an assortment of regular medications would not need to take so many pills. Various medications, adverse interactions and timing of dosage constraints permitting, could be combined into one “superpill”. The only way that we could foresee this working is if pharmacies and manufacturing plants worked together like never before. The pharmaceutical companies would need to set up mini manufacturing plants across the world to be in relatively close proximity to all pharmacies. Prescription filling requests at the local pharmacy would also have to be electronically linked to manufacturing plants. While this sounds like an appealing idea, the costs associated would be too prohibitive.