Evaluation of marking technology for risk management in the biopharmaceutical supply chain

Abstract

Amgen is a leader in the biopharmaceutical industry. It manufacturers and provides human therapeutics that drastically improve lives. Amgen's reputation and brand, its goodwill, is an invaluable asset to its ability to succeed in an increasingly competitive landscape. Because of this, risk management, both in manufacturing and in supply chain arenas, are directly linked to continuing long-term sustainable growth. With an increasingly global market and expanding pipelines, biotechnology companies, like Amgen, face a supply chain challenge to manufacture and distribute products using economically feasible methods that ensure patient safety. Preventing product mix-ups plays a key role in ensuring that safety. Marking nude product that moves intra-Amgen or to contract manufacturers will provide a higher level of confidence that the right product is reaching the patient. Several solutions for marking nude vials and syringes immediately rise to the top of the strata of potential technologies. Despite being promising, each technological solution has key unknowns that must be answered by rigorous labscale testing to provide quantitative data to make the best decision on the future of this process within Amgen. Along with the testing, it is clear that the financial landscape of the different solutions varies a great deal. Each potential solution will be analyzed to determine its capital requirements as well as ongoing costs. Lastly, the solution must be realistic to implement into Amgen's current GMP. And thus, each technology will be evaluated as it relates to the overall complexity of implementation into an already tightly controlled process. From a more macroscopic industry perspective, the FDA, as well as other regulatory agencies, has been discussing this issue for several years. Strategically, biotechnology companies are all hesitant to invest in a particular solution at the moment for fear that the FDA will require a different solution in the near term. In reality, biotechnology companies risk billions in R&D and drug development and are therefore, in a way, naturally risk averse when it comes to their processes and operations. Inventory and manufacturing operations are more driven by risk management than by cost. Of course, the important factor to remember is that risk management is a precursor to drug quality and patient safety. The majority of the risks that are controlled are risks that would either prevent environmental contamination of the drugs or affect the quality of the drugs. Altruistic or not, this has profound long term business strategy implications in an ultra-competitive marketplace where another biotechnology firm would certainly oblige taking market share if Amgen were to suffer a reputation ruining event.