Process design and manufacturing strategies in pharmaceutical production

Pfizer's Batch Process Design Model

Pfizer is a global pharmaceutical manufacturer heavily invested in drug discovery (Pfizer, 2013a). Accordingly, the supply chain needs of Pfizer are atypical of most manufacturers because a significant portion of its production activities must be tailored to meet the needs of researchers investigating the efficacy of drugs in clinical trials. The needs of the research and development arm of Pfizer therefore dominate the process development structure of the company.

Pfizer is in the business of supplying drugs for human and animal consumption; however, before a drug candidate can be brought to market it must win regulatory approval through clinical trials (Pfizer, 2013b). Drugs must therefore be manufactured initially in small batches and then scaled up as it progresses through the three phases of clinical trials. These drugs can represent small molecules manufactured from chemicals, biological derived from plants or animals, or vaccines. Many of these products have short shelf lives and therefore need to be prepared shortly before use. To meet these requirements Pfizer must emphasize consistent quality, on-time delivery, and cost containment.

For the above reasons, Pfizer cannot depend upon a make to stock process design because it would be difficult to predict whether a drug candidate will successfully transition through each phase of the clinical trial. A make to stock process design would therefore add unnecessary costs to the research and development process whenever stocks were rendered useless by the failure of a drug candidate to pass muster in clinical trials.

A make to order process design would make little sense as well, since the doctors involved in clinical trials have no interest in customizing a drug preparation for each customer. Doing so would defeat the purpose of the clinical trials, which is to determine the efficacy and safety of a drug when administered to the general public. In other words, Pfizer is interested in understanding how safe and effective a drug is in everyone. The process design strategy utilized by Pfizer is therefore batch.